<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/NCT02991989</url>
  </required_header>
  <id_info>
    <org_study_id>UoB-ESS-01</org_study_id>
    <nct_id>NCT02991989</nct_id>
  </id_info>
  <brief_title>Does Exercise Snacking Improve Muscle Function in Older Adults?</brief_title>
  <official_title>Does Exercise Snacking Improve Muscle Function in Older Adults?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Bath</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Bath</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Muscle size declines at around 0.5-1% per year after 50 years of age, with muscle strength&#xD;
      declining up to twice as fast as muscle size. This may eventually lead to loss of&#xD;
      independence if tasks of daily living become too strenuous to be performed safely. Exercise&#xD;
      is recognized as a safe and effective means to counteract muscle loss during aging, however&#xD;
      access to gym equipment may be logistically challenging or unpalatable to older adults. This&#xD;
      research is designed to investigate the effect of 28 days of home-based leg exercise that&#xD;
      doesn't require exercise equipment or supervision (exercise snacking), accompanied with a&#xD;
      daily protein supplement in the form of commercially available yogurt, on the skeletal muscle&#xD;
      health (i.e. function and size) of independent, community-dwelling older adults. To achieve&#xD;
      this, two groups will be compared; one group will undertake exercise snacking and consume a&#xD;
      150 g yogurt with the breakfast meal for four weeks, with the second group only receiving the&#xD;
      daily yogurt with no exercise snacking.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will require potential participants to undergo an eligibility screening with a&#xD;
      member of the research team, followed by a period of seven days of habitual activity&#xD;
      monitoring and 3 days of diet recording. Eligible participants will be allocated into study&#xD;
      groups by way of minimization based on sex, age, BMI, and number of sit-to-stands performed&#xD;
      in a minute. Participants will undertake two familiarisation sessions with strength, power,&#xD;
      neural drive, and balance tests at least seven days apart, the first following eligibility&#xD;
      screening and the second familiarisation session at least five days before the first main&#xD;
      trial.&#xD;
&#xD;
      Thereafter, both groups will undertake a main trial the day before commencing 28 days of&#xD;
      daily 150 g yoghurt supplement with the breakfast meal, with the exercise snacking group (ES)&#xD;
      also undertaking two bouts of exercise snacking a day. The main trial will include measures&#xD;
      of leg muscle function and neural drive, standing and single leg balance, and movement&#xD;
      co-ordination during tasks of everyday ambulation. Participants will wear a physical activity&#xD;
      monitor and pedometer for the seven days and record diet for three days during the last week&#xD;
      of the intervention. The day after the intervention period, a follow-up main trial will be&#xD;
      conducted as per the first main trial, followed by an optional qualitative interview&#xD;
      regarding participant's experience of the trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 20, 2016</start_date>
  <completion_date type="Actual">July 2017</completion_date>
  <primary_completion_date type="Actual">June 1, 2017</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>60 second sit to stand test</measure>
    <time_frame>28 days- change from pre- to post- intervention period</time_frame>
    <description>The participant is asked to stand up from sitting in a chair whilst keeping their arms folded across their chest, then return to the seated position as many times as possible in a minute.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Lower limb muscle power</measure>
    <time_frame>28 days- change from pre- to post- intervention period</time_frame>
    <description>Measured during leg pressing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lower limb movement outcome variability</measure>
    <time_frame>28 days- change from pre- to post- intervention period</time_frame>
    <description>Measured during leg pressing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lower limb muscle cross-sectional area</measure>
    <time_frame>28 days- change from pre- to post- intervention period</time_frame>
    <description>Measured using peripheral quantitative computed tomography at 66% distal calf length and 25% and 50% distal thigh length</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lower limb muscle cross-sectional tissue density</measure>
    <time_frame>28 days- change from pre- to post- intervention period</time_frame>
    <description>Measured using peripheral quantitative computed tomography at 66% distal calf length and 25% and 50% distal thigh length</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body composition</measure>
    <time_frame>28 days- change from pre- to post- intervention period</time_frame>
    <description>Measured using Dual Energy X-ray Absorptiometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gastrocnemius and quadriceps muscle fibre pennation angle</measure>
    <time_frame>28 days- change from pre- to post- intervention period</time_frame>
    <description>Measured using ultrasonography at 66% distal length of calf length and 50% distal thigh length</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gastrocnemius and quadriceps muscle fibre length</measure>
    <time_frame>28 days- change from pre- to post- intervention period</time_frame>
    <description>Measured using ultrasonography at 66% distal length of calf length and 50% distal thigh length</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postural sway during standing balance with eyes open and closed</measure>
    <time_frame>28 days- change from pre- to post- intervention period</time_frame>
    <description>Measured using a force plate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Single leg balance</measure>
    <time_frame>28 days- change from pre- to post- intervention period</time_frame>
    <description>Measured using the Y-balance test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Six minute walk test</measure>
    <time_frame>28 days- change from pre- to post- intervention period</time_frame>
    <description>The participant will be asked to walk as many times between two cones places 15 meters apart as possible in six minutes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Movement co-ordination during walking and sit to stands</measure>
    <time_frame>28 days- change from pre- to post- intervention period</time_frame>
    <description>Measured by Qualisys motion capture and force plates</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Central drive of the plantar flexors</measure>
    <time_frame>28 days- change from pre- to post- intervention period</time_frame>
    <description>Measured through the interpolated twitch technique</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Muscle Function</condition>
  <arm_group>
    <arm_group_label>Exercise Snacking Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For 28 days, this group will be asked to perform two 'exercise snacks' a day; once in the morning and once in the evening. They will also be asked to consume 150 g of yogurt with the breakfast meal. The yogurt will be provided by the researchers.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Yogurt Only Group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>For 28 days, this group will be asked to consume 150 g of yogurt with the breakfast meal. The yogurt will be provided by the researchers. Apart from consuming the yogurt, this group will be asked to continue their normal lifestyle.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise Snacking</intervention_name>
    <description>Each bout of exercise snacking consists of 5 exercise. Each exercise is performed for one minute, with aim of completing as many repetitions as possible of that exercise in that minute. One minute of rest is observed between each exercise of the exercise snack. The five exercises are; sit-to-stand from a chair, marching on the spot, seated knee extensions alternating legs, standing knee bends alternating legs, and standing calf raises. The sit-to-stand exercise is always performed first, with the number of repetitions achieved recorded, and subsequent exercises performed in any order without recording of repetitions.&#xD;
Two exercise snacks are completed each day for 28 days; once in the morning and once in the evening, or at least separated by 2 hours.</description>
    <arm_group_label>Exercise Snacking Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Yogurt</intervention_name>
    <description>Participants are asked to consume 150 g of yogurt (Arla, Skyr- natural flavour) with their breakfast meal. Participants may substitute the yogurt for another part of their regular breakfast, or add the yogurt to their regular breakfast, with participants asked to record a log book of daily yogurt consumption and to complete a three day food diary during the last week of the 28 day intervention period.</description>
    <arm_group_label>Exercise Snacking Group</arm_group_label>
    <arm_group_label>Yogurt Only Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Not underweight or obese (body mass index ≥20 and ≤ 30 kg/m2)&#xD;
&#xD;
          -  Not regularly engaging in recreational sports or structured exercise (once a week or&#xD;
             more).&#xD;
&#xD;
          -  Non-smoker (for &gt;5 years)&#xD;
&#xD;
          -  Healthy (see exclusion criteria)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any chronic illness, cardiac, pulmonary, liver, or kidney abnormalities, uncontrolled&#xD;
             hypertension, peripheral arterial disease, insulin- or non-insulin dependent diabetes&#xD;
             or other metabolic disorders - all ascertained through preliminary screening.&#xD;
&#xD;
          -  Individuals with a history of bone, joint or neuromuscular problems or a current&#xD;
             musculoskeletal injury ascertained through preliminary screening.&#xD;
&#xD;
          -  Individuals with any joint replacement surgical implants or other artifacts containing&#xD;
             metal.&#xD;
&#xD;
          -  Individuals with a clinically diagnosed allergy or intolerance of dairy products.&#xD;
&#xD;
          -  Individuals with contraindications to exercise including chest pain, dizziness, or&#xD;
             loss of consciousness, or who have been instructed by their doctor to only do physical&#xD;
             activity recommended by them.&#xD;
&#xD;
          -  Individuals who score less than 8 on the Short Physical Performance Battery or score&#xD;
             zero on any component of the test.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Keith Stokes, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Bath</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Bath</name>
      <address>
        <city>Bath</city>
        <state>Avon</state>
        <zip>BA2 7AY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 9, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <last_update_submitted>May 21, 2018</last_update_submitted>
  <last_update_submitted_qc>May 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Bath</investigator_affiliation>
    <investigator_full_name>Mr Oliver Perkin</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <keyword>Home-based exercise</keyword>
  <keyword>Exercise snacking</keyword>
  <keyword>Protein</keyword>
  <keyword>Yogurt</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Individual participant data will not be shared with other researchers</ipd_description>
  </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/NCT02991989
org study id: UoB-ESS-01
nct id: NCT02991989
lead sponsor: 
has dmc: No
Muscle size declines at around 0.5-1% per year after 50 years of age, with muscle strength
      declining up to twice as fast as muscle size. This may eventually lead to loss of
      independence if tasks of daily living become too strenuous to be performed safely. Exercise
      is recognized as a safe and effective means to counteract muscle loss during aging, however
      access to gym equipment may be logistically challenging or unpalatable to older adults. This
      research is designed to investigate the effect of 28 days of home-based leg exercise that
      doesn't require exercise equipment or supervision (exercise snacking), accompanied with a
      daily protein supplement in the form of commercially available yogurt, on the skeletal muscle
      health (i.e. function and size) of independent, community-dwelling older adults. To achieve
      this, two groups will be compared; one group will undertake exercise snacking and consume a
      150 g yogurt with the breakfast meal for four weeks, with the second group only receiving the
      daily yogurt with no exercise snacking.
The study will require potential participants to undergo an eligibility screening with a
      member of the research team, followed by a period of seven days of habitual activity
      monitoring and 3 days of diet recording. Eligible participants will be allocated into study
      groups by way of minimization based on sex, age, BMI, and number of sit-to-stands performed
      in a minute. Participants will undertake two familiarisation sessions with strength, power,
      neural drive, and balance tests at least seven days apart, the first following eligibility
      screening and the second familiarisation session at least five days before the first main
      trial.

      Thereafter, both groups will undertake a main trial the day before commencing 28 days of
      daily 150 g yoghurt supplement with the breakfast meal, with the exercise snacking group (ES)
      also undertaking two bouts of exercise snacking a day. The main trial will include measures
      of leg muscle function and neural drive, standing and single leg balance, and movement
      co-ordination during tasks of everyday ambulation. Participants will wear a physical activity
      monitor and pedometer for the seven days and record diet for three days during the last week
      of the intervention. The day after the intervention period, a follow-up main trial will be
      conducted as per the first main trial, followed by an optional qualitative interview
      regarding participant's experience of the trial.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: 60 second sit to stand test
time frame: 28 days- change from pre- to post- intervention period
description: The participant is asked to stand up from sitting in a chair whilst keeping their arms folded across their chest, then return to the seated position as many times as possible in a minute.
measure: Lower limb muscle power
time frame: 28 days- change from pre- to post- intervention period
description: Measured during leg pressing
measure: Lower limb movement outcome variability
time frame: 28 days- change from pre- to post- intervention period
description: Measured during leg pressing
measure: Lower limb muscle cross-sectional area
time frame: 28 days- change from pre- to post- intervention period
description: Measured using peripheral quantitative computed tomography at 66% distal calf length and 25% and 50% distal thigh length
measure: Lower limb muscle cross-sectional tissue density
time frame: 28 days- change from pre- to post- intervention period
description: Measured using peripheral quantitative computed tomography at 66% distal calf length and 25% and 50% distal thigh length
measure: Body composition
time frame: 28 days- change from pre- to post- intervention period
description: Measured using Dual Energy X-ray Absorptiometry
measure: Gastrocnemius and quadriceps muscle fibre pennation angle
time frame: 28 days- change from pre- to post- intervention period
description: Measured using ultrasonography at 66% distal length of calf length and 50% distal thigh length
measure: Gastrocnemius and quadriceps muscle fibre length
time frame: 28 days- change from pre- to post- intervention period
description: Measured using ultrasonography at 66% distal length of calf length and 50% distal thigh length
measure: Postural sway during standing balance with eyes open and closed
time frame: 28 days- change from pre- to post- intervention period
description: Measured using a force plate
measure: Single leg balance
time frame: 28 days- change from pre- to post- intervention period
description: Measured using the Y-balance test
measure: Six minute walk test
time frame: 28 days- change from pre- to post- intervention period
description: The participant will be asked to walk as many times between two cones places 15 meters apart as possible in six minutes.
measure: Movement co-ordination during walking and sit to stands
time frame: 28 days- change from pre- to post- intervention period
description: Measured by Qualisys motion capture and force plates
measure: Central drive of the plantar flexors
time frame: 28 days- change from pre- to post- intervention period
description: Measured through the interpolated twitch technique
arm group label: Exercise Snacking Group
arm group type: Experimental
description: For 28 days, this group will be asked to perform two 'exercise snacks' a day; once in the morning and once in the evening. They will also be asked to consume 150 g of yogurt with the breakfast meal. The yogurt will be provided by the researchers.
arm group label: Yogurt Only Group
arm group type: Other
description: For 28 days, this group will be asked to consume 150 g of yogurt with the breakfast meal. The yogurt will be provided by the researchers. Apart from consuming the yogurt, this group will be asked to continue their normal lifestyle.
intervention type: Behavioral
intervention name: Exercise Snacking
description: Each bout of exercise snacking consists of 5 exercise. Each exercise is performed for one minute, with aim of completing as many repetitions as possible of that exercise in that minute. One minute of rest is observed between each exercise of the exercise snack. The five exercises are; sit-to-stand from a chair, marching on the spot, seated knee extensions alternating legs, standing knee bends alternating legs, and standing calf raises. The sit-to-stand exercise is always performed first, with the number of repetitions achieved recorded, and subsequent exercises performed in any order without recording of repetitions.
Two exercise snacks are completed each day for 28 days; once in the morning and once in the evening, or at least separated by 2 hours.
arm group label: Exercise Snacking Group
intervention type: Dietary Supplement
intervention name: Yogurt
description: Participants are asked to consume 150 g of yogurt (Arla, Skyr- natural flavour) with their breakfast meal. Participants may substitute the yogurt for another part of their regular breakfast, or add the yogurt to their regular breakfast, with participants asked to record a log book of daily yogurt consumption and to complete a three day food diary during the last week of the 28 day intervention period.
arm group label: Exercise Snacking Group
arm group label: Yogurt Only Group
criteria: 
gender: All
minimum age: 65 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Keith Stokes, PhD
role: Principal Investigator
affiliation: University of Bath
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: University of Bath
investigator full name: Mr Oliver Perkin
investigator title: Principle Investigator
sharing ipd: No
ipd description: Individual participant data will not be shared with other researchers