<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03297632</url>
  </required_header>
  <id_info>
    <org_study_id>VCC-LIFE-3</org_study_id>
    <nct_id>NCT03297632</nct_id>
  </id_info>
  <brief_title>Improving Muscle Strength, Mass and Physical Function in Older Adults</brief_title>
  <official_title>Functionally Designed Resistance Exercise With the Aim of Improving Balance, Muscle Strength, Muscle Mass and Physical Function of the Elderly: a Randomized Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Region Västerbotten</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Region Västerbotten</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Falls and fractures are serious and costly events for elderly individuals: they cause&#xD;
      functional impairments, increase mortality and contribute to huge healthcare costs for the&#xD;
      society. The number of falls, and following consequences, are expected to increase in society&#xD;
      as the proportion of the elderly population will increase, therefore it is crucial to be able&#xD;
      to detect and prevent falls and fractures in the population. The investigators have&#xD;
      previously published results that objective measurements of postural balance can predict fall&#xD;
      risk in 70-year-olds in Umeå and subsequently investigated whether balance can be improved&#xD;
      through 4-week balance exercise program. However, preliminary results suggest that the&#xD;
      frequency and duration of exercise should be longer than 3 times a week for 4 weeks to&#xD;
      produce effects. Furthermore, there is also evidence indicating a link between muscle&#xD;
      weakness and fall risk in elderly subjects, while research findings show that it is possible&#xD;
      for older individuals to influence muscle strength and muscle mass with resistance exercise.&#xD;
      Functional strength training can also positively influence the balance. In this context, the&#xD;
      investigators aim to investigate whether a 10-week resistance exercise program may positively&#xD;
      affect balance, muscle strength, muscle mass and physical function, with the aim of&#xD;
      preventing future falls and fractures in the population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background:&#xD;
&#xD;
      Falls and fall-related injuries are major health concerns for elderly individuals; they cause&#xD;
      functional decline and increased mortality, as well as incurring vast health care costs for&#xD;
      society. Occurrences and consequences of falls are expected to increase globally with the&#xD;
      growing number of elderly individuals. Hence, the improved detection of potential fall risk&#xD;
      markers is of importance when predicting individuals at risk for falls and subsequently for&#xD;
      improving strategies in fall-prevention. Falling can be the end result of intrinsic and&#xD;
      extrinsic factors negatively affecting an individual's ability to maintain balance, which are&#xD;
      often revealed during sequences of body movement. Balance can be both dynamically and&#xD;
      statically measured, the latter involves having the individual in a stationary standing&#xD;
      position, from which results researchers have proposed impaired postural stability as a risk&#xD;
      factor for falling. However, evidence regarding the association of postural instability with&#xD;
      prospective falls is limited, and population-based cohort studies in this field are scarce.&#xD;
      Other shortcomings of previous studies include the use of retrospective study designs, which&#xD;
      increase the risks of recall bias and the identification of risk factors as the result of&#xD;
      falls.&#xD;
&#xD;
      Postural instability is preferably investigated using objective measures of posturography,&#xD;
      which has advantages over regular clinical assessments since it reduces test performance&#xD;
      variability and avoids the subjective nature of scoring systems. Recently, researchers has&#xD;
      analyzed the performance of the Wii Balance Board (WBB) as an instrument for measuring&#xD;
      postural instability, revealing excellent concurrent validity and an ability to complement&#xD;
      existing fall assessments. However, these findings needed to be evaluated in a&#xD;
      population-based sample with a rich set of covariates. Hence, the investigators performed a&#xD;
      prospectively observational study to investigate how objective measures of postural sway&#xD;
      predicted prospective falls in a cohort of more than 1800 community-dwelling men and women,&#xD;
      all of whom were 70 years of age at the time of the investigation.&#xD;
&#xD;
      The results revealed that impaired postural stability can increase the risk of incident falls&#xD;
      by 75 to 90% among older adults in the highest quintile of postural sway, measured during&#xD;
      trials of both eyes open and eyes closed. One of the conclusions was that it would be&#xD;
      valuable to examine the clinical utility of the investigated parameters in future studies,&#xD;
      compare performance to established clinical balance tests, and to investigate whether&#xD;
      strategies to improve balance would reduce the fall risk. Thus, in a follow-up study the&#xD;
      investigators examined wether they could reduce the increased postural sway of participants&#xD;
      who was identified as having abnormal balance values, based on previous measurements. The&#xD;
      investigators also examined participants' functional balance through Time-Up-and-GO (TUG)&#xD;
      performance, together with measures of muscle strength and validated questionnaires on Fear&#xD;
      of Falling and Falls Efficacy. This follow-up study was conducted as a randomized&#xD;
      intervention study, with a total of 52 individuals recruited from the existing HAI study&#xD;
      cohort, with measures of postural sway in the 5th quintile, which indicated impaired balance&#xD;
      function. The intervention group performed three supervised group training sessions a week,&#xD;
      consisting of 30 minutes of balance training for 4 weeks while the control group received a&#xD;
      health consultation highlighting the importance of physical activity and balance exercise.&#xD;
      Preliminary data indicated that the exercise intervention had little to no effect on selected&#xD;
      measures on balance, strength and physical function. Thus, it may seem that a exercise volume&#xD;
      of 4 weeks of progressive balance exercise, 3 sessions per week, might be to low to produce&#xD;
      beneficial effects.&#xD;
&#xD;
      The results from this previous study indicated the need for a more comprehensive exercise&#xD;
      program in order to produce beneficial effects on balance, strength and physical function,&#xD;
      and in the long term, fall prevention. Previous research has shown that low muscle strength&#xD;
      together with low muscle mass, also known as sarcopenia, independently predicts falls,&#xD;
      fractures and overall poor health. However, a growing body of evidence also indicates that&#xD;
      older individuals are able to counteract the trend of age-related loss of muscle mass, as&#xD;
      well as improve dynamic balance, through the use of resistance exercise. For older&#xD;
      individuals, it is recommended that the exercise regimen lasts for 10-12 weeks, with 3&#xD;
      exercise sessions each week, in order to produce effects on muscle strength, muscle mass and&#xD;
      physical function, which is a higher total exercise volume than what was used in the balance&#xD;
      exercise study.&#xD;
&#xD;
      Aims:&#xD;
&#xD;
        1. The primary aim of the current study is to investigate the effect and feasibility of a&#xD;
           10-week instructor-supervised resistance exercise program designed for older individuals&#xD;
           with low muscle mass. The goal is to implement exercises that are possible for the&#xD;
           participants to also perform in their home environment, through the use of basic&#xD;
           equipment.&#xD;
&#xD;
        2. A secondary aim is to evaluate the effect of the very same exercise program, recorded in&#xD;
           digital videos and written instructions, to be used by the participant in their own&#xD;
           residence or similar location.&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      Recruitment is based on participants previously enrolled in the Healthy Ageing Initiative&#xD;
      (HAI) health examination, an on-going population based cohort study which invites all&#xD;
      70-year-olds in the Umeå municipality to participate. Eligible participants for this study&#xD;
      will be drawn from the lowest quintile of muscle mass (pre-sarcopenia) for men and women,&#xD;
      based on Dual-Energy X-ray Absorptiometry (DEXA, GE Healthcare, Lunar, Madison, WI, USA)&#xD;
      measurements in the HAI study and criteria taken from the European definition on sarcopenia.&#xD;
      Participants are first contacted by telephone where they receive information about the study&#xD;
      and are invited to participate. Upon agreement, participants are randomized either to the&#xD;
      control group, a home-based training group or instructor-led training group. The latter group&#xD;
      is offered instructor-based weight training in groups, three times a week for 10 weeks. The&#xD;
      exercise program is designed to engage whole-body muscle groups, with focus on leg and core&#xD;
      musculature, as well as being functional and include movements and muscle actions important&#xD;
      for active daily living. The home-based training includes 10 weeks of the same exercise&#xD;
      program, performed at home with digital support. The control group are offered access to&#xD;
      training instructions as well as digital support during follow up 6 months after the start of&#xD;
      the study. In addition, all participants receive cost-free training equipment for home use.&#xD;
&#xD;
      Testing is performed at baseline, after the intervention period during follow-up at 10 weeks,&#xD;
      as well as 6 months after baseline. The following tests and outcomes are included:&#xD;
&#xD;
        1. Primary outcome is Short Physical Performance Battery (SPPB) test score. The SPPB&#xD;
           includes several functional tests evaluating leg strength and power, postural stability&#xD;
           and gait speed. The SPPB is a common and validated clinical test of physical function.&#xD;
&#xD;
        2. Secondary outcomes include:&#xD;
&#xD;
             -  Objective measurement of postural stability, using the Wii Balance Board (WBB;&#xD;
                Nintendo, Kyoto, Japan) device, described and validated in a previously published&#xD;
                study (8). Each participant conducts two 60-s trials in a quiet stance, consisting&#xD;
                of eyes-open (EO) and eyes-closed (EC) conditions. Participants are instructed to&#xD;
                maintain an upright position throughout the test, stand relaxed and avoid any arm&#xD;
                or head movement. The WBB measures total centre of pressure (COP) sway length,&#xD;
                representing the sum of postural sway in the anteroposterior and mediolateral&#xD;
                directions.&#xD;
&#xD;
             -  Isometric muscle strength, tested by using a hydraulic hand dynamometer (Jamar;&#xD;
                Patterson Medical, Warrenville, IL, USA) to measure each participant's maximum grip&#xD;
                strength in the non-dominant hand. Participants are instructed to keep the arm at a&#xD;
                90° angle and to maintain the elbow in proximity to the waist during the test. The&#xD;
                maximum value obtained in two consecutive attempts is recorded.&#xD;
&#xD;
             -  Appendicular lean mass (ALM), measured with a iDXA device (GE Healthcare, Lunar,&#xD;
                Madison, WI, USA). Measurements are based on whole-body scans with a duration of&#xD;
                approximately 8 minutes. An ALM index is subsequently calculated by combining the&#xD;
                total muscle mass in arms and legs and dividing by height squared (ALM/m2) of the&#xD;
                participant, according to the standards set by the European Working Group on&#xD;
                Sarcopenia in Older People (EWGSOP).&#xD;
&#xD;
             -  Timed-Up-and-Go (TUG) test performance, a test commonly used by clinicians to&#xD;
                assess lower leg muscle strength, gait performance, and overall functional mobility&#xD;
                in elderly individuals. In this test, each participant are asked to rise unaided&#xD;
                from an armchair and walk forward 3 meters until he or she reached a line marked on&#xD;
                the floor, then to turn around and return to a seated position in the chair. Test&#xD;
                leaders provide instructions and measure total testing time using a stopwatch.&#xD;
&#xD;
             -  Objective measures of physical activity, measured by triaxial accelerometers&#xD;
                (GT3X., 4.6 3.3 1.5 cm; Actigraph, Pensacola, FL) for 7 days. These devices are&#xD;
                capable of measuring acceleration in the range of 6 G. Measured accelerations are&#xD;
                digitalized, transformed into &quot;counts,&quot; and stored in a resilient flash memory.&#xD;
                Participants wear the accelerometers on their non-dominant hips, removing them only&#xD;
                when showering, swimming, or during nighttime sleep. They also receive instructions&#xD;
                to be normally active during the measurement period, to obtain accurate reflections&#xD;
                of their lifestyles.&#xD;
&#xD;
             -  Fear of Falling, using the validated Falls Efficacy Scale-International (FES-I)&#xD;
                questionnaire.&#xD;
&#xD;
             -  Self-recalled physical activity, using the validated International Physical&#xD;
                Activity Questionnaire (IPAQ) Furthermore, the investigators aim to investigate&#xD;
                postural stability, TUG test performance, Fear of Falling and self-recalled&#xD;
                physical activity 4 weeks after baseline, in order to facilitate comparison between&#xD;
                resistance exercise to the balance exercise program performed in the previous 4-&#xD;
                week randomized controlled trial (Ethical approval Dnr: 2017-132-31).&#xD;
&#xD;
      Statistical power analysis:&#xD;
&#xD;
      The power calculation is based on the main outcome for the study, i.e. the short physical&#xD;
      performance battery (SPPB). SPPB was previously tested in 2.710 older sample of Italian&#xD;
      adults with a mean age of 75 (range 65-97). Women scored 7.79±3.22 (mean ± standard&#xD;
      deviation) and men scored 9.03±3.12. In the present study the investigators will include a&#xD;
      more homogeneous sample of younger age but with pre-sarcopenia. Therefore, estimations are&#xD;
      that the score in this sample at baseline will be 8±2.5. From a previous study including 424&#xD;
      elderly persons at risk for disability (ages 70-89 years), it was shown that SPPB increased&#xD;
      16% from 6 months of moderate physical activity in the intervention group, which decreased&#xD;
      slightly to 13.3% after 1 year. These effects were significantly different compared to in the&#xD;
      control group (p&lt;0.001), where no changes were seen in SPPB. There was slightly better effect&#xD;
      of training in women and those with a SPPB of at least 7 at baseline. Based on these figures&#xD;
      the investigators estimate that the intervention group will increase 12% in SPPB during the&#xD;
      10 weeks of training, with no changes in the control group. Based on these assumptions, 107&#xD;
      persons will be needed in each group, to have 80% power to detect a two-sided effect with&#xD;
      α-level of 0.05.&#xD;
&#xD;
      In the first round of enrollment starting this fall, the investigators have begun randomizing&#xD;
      36 participants to each group. The aim is to continue and enroll remaining participants&#xD;
      during the second round starting late spring/early fall 2018.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">September 4, 2017</start_date>
  <completion_date type="Anticipated">November 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">November 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Postural Stability performance</measure>
    <time_frame>Change in Postural Stability performance at 10 and 34 weeks</time_frame>
    <description>Postural stability measurement task from the Short Physical Performance Battery (SPPB), containing bipedal, semi-tandem and tandem stances. Measured in seconds, up to a maximal value of 10 seconds.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Gait Speed</measure>
    <time_frame>Change in Gait Speed at 10 and 34 weeks</time_frame>
    <description>Gait speed measurement task from the Short Physical Performance Battery (SPPB). Measured in the seconds it takes to walk 4 meters.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Chair Stand performance</measure>
    <time_frame>Change in Chair stand performance at 10 and 34 weeks</time_frame>
    <description>Chair stand measurement task from the Short Physical Performance Battery (SPPB). Measures in the time it takes to stand up 5 times.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Postural Sway</measure>
    <time_frame>Change in Baseline Postural Sway at 10 and 34 weeks</time_frame>
    <description>Total postural sway length, measured objectively during trials of eyes open and eyes closed, during 60 seconds each</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Isometric Muscle Strength</measure>
    <time_frame>Change in Baseline Isometric Muscle Strength at 10 and 34 weeks</time_frame>
    <description>Measured by using a hydraulic hand dynamometer. The maximum value obtained in two consecutive attempts is recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Appendicular Muscle Mass</measure>
    <time_frame>Change in Baseline Appendicular Muscle Mass at 10 and 34 weeks</time_frame>
    <description>Measured with a iDXA device. Measurements are based on whole-body scans with a duration of approximately 8 minutes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in TUG test performance</measure>
    <time_frame>Change in Baseline TUG test performance at 10 and 34 weeks</time_frame>
    <description>The Timed-Up-and-Go test is commonly used by clinicians to assess lower leg muscle strength, gait performance, and overall functional mobility in elderly individuals</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Physical Activity</measure>
    <time_frame>Change in Baseline Physical Activity at 10 and 34 weeks</time_frame>
    <description>Objective measures through the use of triaxial accelerometers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fear of Falling</measure>
    <time_frame>Change in Baseline Fear of Falling at 10 and 34 weeks</time_frame>
    <description>Assessed with the validated Falls Efficacy Scale-International questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in self-recalled Physical Activity</measure>
    <time_frame>Change in Baseline self-recalled Physical Activity at 10 and 34 weeks</time_frame>
    <description>Assessed with the validated International Physical Activity Questionnaire</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">210</enrollment>
  <condition>Muscle Weakness</condition>
  <condition>Fall</condition>
  <condition>Sarcopenia</condition>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Receives instructor-based functional resistance exercise. 45 minutes per session. 3 times per week, during 10 weeks in total.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Asked to normally active according to their current lifestyle</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Home-based group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Receives home-based exercises with written instructions and digital video support. 45 minutes per session. 3 times per week, during 10 weeks in total.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Functional resistance exercise</intervention_name>
    <description>Functional resistance program designed for older individuals with low muscle mass and muscle strength. The goal is to implement exercises that are possible for the participants to also perform in their home environment, through the use of basic equipment.</description>
    <arm_group_label>Home-based group</arm_group_label>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participation in the Healthy Ageing Initiative (HAI) study&#xD;
&#xD;
          -  Appendicular lean mass index in the lowest 20% measured with the iDXA in the HAI&#xD;
             study, separate for men and women.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to be present during all 10 weeks of exercise.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>70 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Livsmedicin (LIFE)</name>
      <address>
        <city>Umeå</city>
        <state>Västerbotten</state>
        <zip>907 36</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
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  </reference>
  <reference>
    <citation>Iolascon G, Di Pietro G, Gimigliano F, Mauro GL, Moretti A, Giamattei MT, Ortolani S, Tarantino U, Brandi ML. Physical exercise and sarcopenia in older people: position paper of the Italian Society of Orthopaedics and Medicine (OrtoMed). Clin Cases Miner Bone Metab. 2014 Sep;11(3):215-21.</citation>
    <PMID>25568656</PMID>
  </reference>
  <reference>
    <citation>Veronese N, Bolzetta F, Toffanello ED, Zambon S, De Rui M, Perissinotto E, Coin A, Corti MC, Baggio G, Crepaldi G, Sergi G, Manzato E. Association between Short Physical Performance Battery and falls in older people: the Progetto Veneto Anziani Study. Rejuvenation Res. 2014 Jun;17(3):276-84. doi: 10.1089/rej.2013.1491. Epub 2014 Jun 11.</citation>
    <PMID>24387140</PMID>
  </reference>
  <reference>
    <citation>LIFE Study Investigators; Pahor M, Blair SN, Espeland M, Fielding R, Gill TM, Guralnik JM, Hadley EC, King AC, Kritchevsky SB, Maraldi C, Miller ME, Newman AB, Rejeski WJ, Romashkan S, Studenski S. Effects of a physical activity intervention on measures of physical performance: Results of the lifestyle interventions and independence for Elders Pilot (LIFE-P) study. J Gerontol A Biol Sci Med Sci. 2006 Nov;61(11):1157-65. doi: 10.1093/gerona/61.11.1157. Erratum In: J Gerontol A Biol Sci Med Sci. 2007 Mar;62(3):337.</citation>
    <PMID>17167156</PMID>
  </reference>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 29, 2017</study_first_posted>
  <last_update_submitted>October 25, 2018</last_update_submitted>
  <last_update_submitted_qc>October 25, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Region Västerbotten</investigator_affiliation>
    <investigator_full_name>Anna Nordström</investigator_full_name>
    <investigator_title>Adjunct Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscle Weakness</mesh_term>
    <mesh_term>Sarcopenia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03297632
org study id: VCC-LIFE-3
nct id: NCT03297632
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Falls and fractures are serious and costly events for elderly individuals: they cause
      functional impairments, increase mortality and contribute to huge healthcare costs for the
      society. The number of falls, and following consequences, are expected to increase in society
      as the proportion of the elderly population will increase, therefore it is crucial to be able
      to detect and prevent falls and fractures in the population. The investigators have
      previously published results that objective measurements of postural balance can predict fall
      risk in 70-year-olds in Umeå and subsequently investigated whether balance can be improved
      through 4-week balance exercise program. However, preliminary results suggest that the
      frequency and duration of exercise should be longer than 3 times a week for 4 weeks to
      produce effects. Furthermore, there is also evidence indicating a link between muscle
      weakness and fall risk in elderly subjects, while research findings show that it is possible
      for older individuals to influence muscle strength and muscle mass with resistance exercise.
      Functional strength training can also positively influence the balance. In this context, the
      investigators aim to investigate whether a 10-week resistance exercise program may positively
      affect balance, muscle strength, muscle mass and physical function, with the aim of
      preventing future falls and fractures in the population.
Background:

      Falls and fall-related injuries are major health concerns for elderly individuals; they cause
      functional decline and increased mortality, as well as incurring vast health care costs for
      society. Occurrences and consequences of falls are expected to increase globally with the
      growing number of elderly individuals. Hence, the improved detection of potential fall risk
      markers is of importance when predicting individuals at risk for falls and subsequently for
      improving strategies in fall-prevention. Falling can be the end result of intrinsic and
      extrinsic factors negatively affecting an individual's ability to maintain balance, which are
      often revealed during sequences of body movement. Balance can be both dynamically and
      statically measured, the latter involves having the individual in a stationary standing
      position, from which results researchers have proposed impaired postural stability as a risk
      factor for falling. However, evidence regarding the association of postural instability with
      prospective falls is limited, and population-based cohort studies in this field are scarce.
      Other shortcomings of previous studies include the use of retrospective study designs, which
      increase the risks of recall bias and the identification of risk factors as the result of
      falls.

      Postural instability is preferably investigated using objective measures of posturography,
      which has advantages over regular clinical assessments since it reduces test performance
      variability and avoids the subjective nature of scoring systems. Recently, researchers has
      analyzed the performance of the Wii Balance Board (WBB) as an instrument for measuring
      postural instability, revealing excellent concurrent validity and an ability to complement
      existing fall assessments. However, these findings needed to be evaluated in a
      population-based sample with a rich set of covariates. Hence, the investigators performed a
      prospectively observational study to investigate how objective measures of postural sway
      predicted prospective falls in a cohort of more than 1800 community-dwelling men and women,
      all of whom were 70 years of age at the time of the investigation.

      The results revealed that impaired postural stability can increase the risk of incident falls
      by 75 to 90% among older adults in the highest quintile of postural sway, measured during
      trials of both eyes open and eyes closed. One of the conclusions was that it would be
      valuable to examine the clinical utility of the investigated parameters in future studies,
      compare performance to established clinical balance tests, and to investigate whether
      strategies to improve balance would reduce the fall risk. Thus, in a follow-up study the
      investigators examined wether they could reduce the increased postural sway of participants
      who was identified as having abnormal balance values, based on previous measurements. The
      investigators also examined participants' functional balance through Time-Up-and-GO (TUG)
      performance, together with measures of muscle strength and validated questionnaires on Fear
      of Falling and Falls Efficacy. This follow-up study was conducted as a randomized
      intervention study, with a total of 52 individuals recruited from the existing HAI study
      cohort, with measures of postural sway in the 5th quintile, which indicated impaired balance
      function. The intervention group performed three supervised group training sessions a week,
      consisting of 30 minutes of balance training for 4 weeks while the control group received a
      health consultation highlighting the importance of physical activity and balance exercise.
      Preliminary data indicated that the exercise intervention had little to no effect on selected
      measures on balance, strength and physical function. Thus, it may seem that a exercise volume
      of 4 weeks of progressive balance exercise, 3 sessions per week, might be to low to produce
      beneficial effects.

      The results from this previous study indicated the need for a more comprehensive exercise
      program in order to produce beneficial effects on balance, strength and physical function,
      and in the long term, fall prevention. Previous research has shown that low muscle strength
      together with low muscle mass, also known as sarcopenia, independently predicts falls,
      fractures and overall poor health. However, a growing body of evidence also indicates that
      older individuals are able to counteract the trend of age-related loss of muscle mass, as
      well as improve dynamic balance, through the use of resistance exercise. For older
      individuals, it is recommended that the exercise regimen lasts for 10-12 weeks, with 3
      exercise sessions each week, in order to produce effects on muscle strength, muscle mass and
      physical function, which is a higher total exercise volume than what was used in the balance
      exercise study.

      Aims:

        1. The primary aim of the current study is to investigate the effect and feasibility of a
           10-week instructor-supervised resistance exercise program designed for older individuals
           with low muscle mass. The goal is to implement exercises that are possible for the
           participants to also perform in their home environment, through the use of basic
           equipment.

        2. A secondary aim is to evaluate the effect of the very same exercise program, recorded in
           digital videos and written instructions, to be used by the participant in their own
           residence or similar location.

      Methods:

      Recruitment is based on participants previously enrolled in the Healthy Ageing Initiative
      (HAI) health examination, an on-going population based cohort study which invites all
      70-year-olds in the Umeå municipality to participate. Eligible participants for this study
      will be drawn from the lowest quintile of muscle mass (pre-sarcopenia) for men and women,
      based on Dual-Energy X-ray Absorptiometry (DEXA, GE Healthcare, Lunar, Madison, WI, USA)
      measurements in the HAI study and criteria taken from the European definition on sarcopenia.
      Participants are first contacted by telephone where they receive information about the study
      and are invited to participate. Upon agreement, participants are randomized either to the
      control group, a home-based training group or instructor-led training group. The latter group
      is offered instructor-based weight training in groups, three times a week for 10 weeks. The
      exercise program is designed to engage whole-body muscle groups, with focus on leg and core
      musculature, as well as being functional and include movements and muscle actions important
      for active daily living. The home-based training includes 10 weeks of the same exercise
      program, performed at home with digital support. The control group are offered access to
      training instructions as well as digital support during follow up 6 months after the start of
      the study. In addition, all participants receive cost-free training equipment for home use.

      Testing is performed at baseline, after the intervention period during follow-up at 10 weeks,
      as well as 6 months after baseline. The following tests and outcomes are included:

        1. Primary outcome is Short Physical Performance Battery (SPPB) test score. The SPPB
           includes several functional tests evaluating leg strength and power, postural stability
           and gait speed. The SPPB is a common and validated clinical test of physical function.

        2. Secondary outcomes include:

             -  Objective measurement of postural stability, using the Wii Balance Board (WBB;
                Nintendo, Kyoto, Japan) device, described and validated in a previously published
                study (8). Each participant conducts two 60-s trials in a quiet stance, consisting
                of eyes-open (EO) and eyes-closed (EC) conditions. Participants are instructed to
                maintain an upright position throughout the test, stand relaxed and avoid any arm
                or head movement. The WBB measures total centre of pressure (COP) sway length,
                representing the sum of postural sway in the anteroposterior and mediolateral
                directions.

             -  Isometric muscle strength, tested by using a hydraulic hand dynamometer (Jamar;
                Patterson Medical, Warrenville, IL, USA) to measure each participant's maximum grip
                strength in the non-dominant hand. Participants are instructed to keep the arm at a
                90° angle and to maintain the elbow in proximity to the waist during the test. The
                maximum value obtained in two consecutive attempts is recorded.

             -  Appendicular lean mass (ALM), measured with a iDXA device (GE Healthcare, Lunar,
                Madison, WI, USA). Measurements are based on whole-body scans with a duration of
                approximately 8 minutes. An ALM index is subsequently calculated by combining the
                total muscle mass in arms and legs and dividing by height squared (ALM/m2) of the
                participant, according to the standards set by the European Working Group on
                Sarcopenia in Older People (EWGSOP).

             -  Timed-Up-and-Go (TUG) test performance, a test commonly used by clinicians to
                assess lower leg muscle strength, gait performance, and overall functional mobility
                in elderly individuals. In this test, each participant are asked to rise unaided
                from an armchair and walk forward 3 meters until he or she reached a line marked on
                the floor, then to turn around and return to a seated position in the chair. Test
                leaders provide instructions and measure total testing time using a stopwatch.

             -  Objective measures of physical activity, measured by triaxial accelerometers
                (GT3X., 4.6 3.3 1.5 cm; Actigraph, Pensacola, FL) for 7 days. These devices are
                capable of measuring acceleration in the range of 6 G. Measured accelerations are
                digitalized, transformed into "counts," and stored in a resilient flash memory.
                Participants wear the accelerometers on their non-dominant hips, removing them only
                when showering, swimming, or during nighttime sleep. They also receive instructions
                to be normally active during the measurement period, to obtain accurate reflections
                of their lifestyles.

             -  Fear of Falling, using the validated Falls Efficacy Scale-International (FES-I)
                questionnaire.

             -  Self-recalled physical activity, using the validated International Physical
                Activity Questionnaire (IPAQ) Furthermore, the investigators aim to investigate
                postural stability, TUG test performance, Fear of Falling and self-recalled
                physical activity 4 weeks after baseline, in order to facilitate comparison between
                resistance exercise to the balance exercise program performed in the previous 4-
                week randomized controlled trial (Ethical approval Dnr: 2017-132-31).

      Statistical power analysis:

      The power calculation is based on the main outcome for the study, i.e. the short physical
      performance battery (SPPB). SPPB was previously tested in 2.710 older sample of Italian
      adults with a mean age of 75 (range 65-97). Women scored 7.79±3.22 (mean ± standard
      deviation) and men scored 9.03±3.12. In the present study the investigators will include a
      more homogeneous sample of younger age but with pre-sarcopenia. Therefore, estimations are
      that the score in this sample at baseline will be 8±2.5. From a previous study including 424
      elderly persons at risk for disability (ages 70-89 years), it was shown that SPPB increased
      16% from 6 months of moderate physical activity in the intervention group, which decreased
      slightly to 13.3% after 1 year. These effects were significantly different compared to in the
      control group (p<0.001), where no changes were seen in SPPB. There was slightly better effect
      of training in women and those with a SPPB of at least 7 at baseline. Based on these figures
      the investigators estimate that the intervention group will increase 12% in SPPB during the
      10 weeks of training, with no changes in the control group. Based on these assumptions, 107
      persons will be needed in each group, to have 80% power to detect a two-sided effect with
      α-level of 0.05.

      In the first round of enrollment starting this fall, the investigators have begun randomizing
      36 participants to each group. The aim is to continue and enroll remaining participants
      during the second round starting late spring/early fall 2018.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Investigator, Outcomes Assessor)
measure: Change in Postural Stability performance
time frame: Change in Postural Stability performance at 10 and 34 weeks
description: Postural stability measurement task from the Short Physical Performance Battery (SPPB), containing bipedal, semi-tandem and tandem stances. Measured in seconds, up to a maximal value of 10 seconds.
measure: Change in Gait Speed
time frame: Change in Gait Speed at 10 and 34 weeks
description: Gait speed measurement task from the Short Physical Performance Battery (SPPB). Measured in the seconds it takes to walk 4 meters.
measure: Change in Chair Stand performance
time frame: Change in Chair stand performance at 10 and 34 weeks
description: Chair stand measurement task from the Short Physical Performance Battery (SPPB). Measures in the time it takes to stand up 5 times.
measure: Change in Postural Sway
time frame: Change in Baseline Postural Sway at 10 and 34 weeks
description: Total postural sway length, measured objectively during trials of eyes open and eyes closed, during 60 seconds each
measure: Change in Isometric Muscle Strength
time frame: Change in Baseline Isometric Muscle Strength at 10 and 34 weeks
description: Measured by using a hydraulic hand dynamometer. The maximum value obtained in two consecutive attempts is recorded.
measure: Change in Appendicular Muscle Mass
time frame: Change in Baseline Appendicular Muscle Mass at 10 and 34 weeks
description: Measured with a iDXA device. Measurements are based on whole-body scans with a duration of approximately 8 minutes.
measure: Change in TUG test performance
time frame: Change in Baseline TUG test performance at 10 and 34 weeks
description: The Timed-Up-and-Go test is commonly used by clinicians to assess lower leg muscle strength, gait performance, and overall functional mobility in elderly individuals
measure: Change in Physical Activity
time frame: Change in Baseline Physical Activity at 10 and 34 weeks
description: Objective measures through the use of triaxial accelerometers
measure: Change in Fear of Falling
time frame: Change in Baseline Fear of Falling at 10 and 34 weeks
description: Assessed with the validated Falls Efficacy Scale-International questionnaire
measure: Change in self-recalled Physical Activity
time frame: Change in Baseline self-recalled Physical Activity at 10 and 34 weeks
description: Assessed with the validated International Physical Activity Questionnaire
arm group label: Intervention Group
arm group type: Experimental
description: Receives instructor-based functional resistance exercise. 45 minutes per session. 3 times per week, during 10 weeks in total.
arm group label: Control group
arm group type: No Intervention
description: Asked to normally active according to their current lifestyle
arm group label: Home-based group
arm group type: Active Comparator
description: Receives home-based exercises with written instructions and digital video support. 45 minutes per session. 3 times per week, during 10 weeks in total.
intervention type: Behavioral
intervention name: Functional resistance exercise
description: Functional resistance program designed for older individuals with low muscle mass and muscle strength. The goal is to implement exercises that are possible for the participants to also perform in their home environment, through the use of basic equipment.
arm group label: Home-based group
arm group label: Intervention Group
criteria: 
gender: Female
minimum age: 70 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: Sweden
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PMID: 8126355
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citation: Iolascon G, Di Pietro G, Gimigliano F, Mauro GL, Moretti A, Giamattei MT, Ortolani S, Tarantino U, Brandi ML. Physical exercise and sarcopenia in older people: position paper of the Italian Society of Orthopaedics and Medicine (OrtoMed). Clin Cases Miner Bone Metab. 2014 Sep;11(3):215-21.
PMID: 25568656
citation: Veronese N, Bolzetta F, Toffanello ED, Zambon S, De Rui M, Perissinotto E, Coin A, Corti MC, Baggio G, Crepaldi G, Sergi G, Manzato E. Association between Short Physical Performance Battery and falls in older people: the Progetto Veneto Anziani Study. Rejuvenation Res. 2014 Jun;17(3):276-84. doi: 10.1089/rej.2013.1491. Epub 2014 Jun 11.
PMID: 24387140
citation: LIFE Study Investigators; Pahor M, Blair SN, Espeland M, Fielding R, Gill TM, Guralnik JM, Hadley EC, King AC, Kritchevsky SB, Maraldi C, Miller ME, Newman AB, Rejeski WJ, Romashkan S, Studenski S. Effects of a physical activity intervention on measures of physical performance: Results of the lifestyle interventions and independence for Elders Pilot (LIFE-P) study. J Gerontol A Biol Sci Med Sci. 2006 Nov;61(11):1157-65. doi: 10.1093/gerona/61.11.1157. Erratum In: J Gerontol A Biol Sci Med Sci. 2007 Mar;62(3):337.
PMID: 17167156
responsible party type: Principal Investigator
investigator affiliation: Region Västerbotten
investigator full name: Anna Nordström
investigator title: Adjunct Professor
mesh term: Muscle Weakness
mesh term: Sarcopenia
sharing ipd: Undecided