<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/NCT03765385</url>
  </required_header>
  <id_info>
    <org_study_id>Dnr 2018-307-31M</org_study_id>
    <nct_id>NCT03765385</nct_id>
  </id_info>
  <brief_title>The Umeå High-Intensity Training Study</brief_title>
  <acronym>Umeå HIT</acronym>
  <official_title>The Umeå High-Intensity Training Study: Feasibility and Effect of High-Intensity Training in Older Sedentary People</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Umeå University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Umeå University</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>
      This randomized controlled trial will evaluate the effect of high-intensity training (HIT) in&#xD;
      older sedentary people. Seventy older people, aged 65 and over, will be randomized to HIT or&#xD;
      moderate-intensity continuous training (MICT). HIT sessions will consist of 10 repeated&#xD;
      6-seconds regulated high intensity cycling sprints against an individualized load. MICT&#xD;
      (control group) sessions will consist of aerobic training regulated against an individualized&#xD;
      load set to reach a moderate submaximal exercise intensity. Both groups will be performed&#xD;
      twice weekly for 12 weeks. The study will evaluate the effects on 1) Cardiovascular function,&#xD;
      2) Brain health, 3) Muscular function, 4) Psychological health, 5) Physical activity, 6)&#xD;
      Metabolic health, and 7) Examine the feasibility (attendance, achieved intensity, adverse&#xD;
      events) as well as the experiences of HIT. Most outcomes will be assessed at baseline, 3&#xD;
      months (directly after intervention period), and 9 months by blinded assessors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Information about modifications of the study protocol (September 2020): Experiences of&#xD;
      exercising and its effects were at the 9-month follow-up collected through individual&#xD;
      interviews instead of focus group interviews (secondary outcome measures no. 31). Due to&#xD;
      Covid-19, at the 9-month follow-up all outcome measurements besides the questionnaire&#xD;
      (secondary outcome measures no 9, 10, 11, 12, and 14) and interviews (secondary outcome&#xD;
      measure no 31) were terminated for 37 of the participants.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 13, 2018</start_date>
  <completion_date type="Actual">July 10, 2020</completion_date>
  <primary_completion_date type="Actual">February 5, 2020</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>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>The outcome assessors will be masked to group allocation. The participants will be given repeated instructions not to reveal their group allocation to the outcome assessors. Data set will be blinded regarding group allocation (and the code for the groups will be held by a researcher not involved in the study) when performing analyses for main outcomes.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline cardiovascular capacity at 3 months and at 9 months, respectively.</measure>
    <time_frame>Baseline, 3 months, 9 months</time_frame>
    <description>Maximum oxygen uptake (VO2 max)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline cognitive function at 3 months and at 9 months, respectively.</measure>
    <time_frame>Baseline, 3 months, 9 months</time_frame>
    <description>Measured using standardized tests covering: episodic memory (free recall, paired associates), executive functions (n-back, Trail Making Test (TMT) 4, flanker task), visuospatial ability (spatial relations), working memory (digit span) and processing speed (Trail Making Test (TMT) 2 and 3). The cognitive tasks are first z-transformed and then everaged to form a unit-weighted cognitive score as well as domain specific constructs.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline brain function at 3 months.</measure>
    <time_frame>Baseline, 3 months</time_frame>
    <description>Assessed using functional MRI (fMRI) using two paradigms. Test A will estimate functional brain response during working memory manipulation and maintenance. Test B will estimate brain response during a pattern completion/separation paradigm. Separate analyses will be performed for fMRI paradigm A and B respectively. For each paradigm changes of % signal BOLD change will be analysed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline brain structure at 3 months.</measure>
    <time_frame>Baseline, 3 months</time_frame>
    <description>Assessed using standard MRI-sequences including T1w, T2w, T2-FLAIR. For structural MRI data volume (mm3) and cortical thickness (mm) will be the unit of measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline strength in knee extensors at 3 months and at 9 months, respectively.</measure>
    <time_frame>Baseline, 3 months, 9 months</time_frame>
    <description>Maximal isometric strength in knee extensor measured as normalized joint torque in newton meters per kilogram bodyweight (Nm/kg).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline hand grip strength at 3 months and at 9 months, respectively.</measure>
    <time_frame>Baseline, 3 months, 9 months</time_frame>
    <description>Maximal hand grip strength measured as normalized force in Newtons per kilogram bodyweight (N/kg).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline leg extensor muscle power at 3 months and at 9 months, respectively.</measure>
    <time_frame>Baseline, 3 months, 9 months</time_frame>
    <description>Leg extensor power in the Nottingham Power Rig, measured as peak power output (watt).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline functional performance at 3 months and at 9 months, respectively.</measure>
    <time_frame>Baseline, 3 months, 9 months</time_frame>
    <description>Chair-stand test, number of chair-stands during 30 seconds.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline functional balance at 3 months and at 9 months, respectively.</measure>
    <time_frame>Baseline, 3 months, 9 months</time_frame>
    <description>One-leg stance: number of seconds able to stand on one leg (maximum 120 seconds).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline functional balance at 3 months and at 9 months, respectively.</measure>
    <time_frame>Baseline, 3 months, 9 months</time_frame>
    <description>Step test, number of steps during 30 seconds.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline anxiety and depression at 3 months and at 9 months, respectively.</measure>
    <time_frame>Baseline, 3 months, 9 months</time_frame>
    <description>Hospital anxiety and depression scale (HAD): range 0-42, higher score indicates more symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline health related quality of life at 3 months and at 9 months, respectively.</measure>
    <time_frame>Baseline, 3 months, 9 months</time_frame>
    <description>Short Form Health Survey (SF-36): scores transformed to 0 to 100, higher scores indicates better quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline self-efficacy at 3 months and at 9 months, respectively.</measure>
    <time_frame>Baseline, 3 months, 9 months</time_frame>
    <description>Swedish Exercise Self Efficacy Scale (ESES-S): Range 10-40, higher score indicates more self efficacy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline sleep quality at 3 months and at 9 months, respectively.</measure>
    <time_frame>Baseline, 3 months, 9 months</time_frame>
    <description>One question (no. 3) regarding sleep from Montgomery-Åsberg Depression Rating Scale (MADRS).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline objective physical activity at 1.5 months (mid-training), at 3 months and at 9 months, respectively.</measure>
    <time_frame>Baseline, 1.5 months, 3 months, 9 months</time_frame>
    <description>Physical activity measured by an activity monitor, the Actigraph. Number of steps per day and number of activity counts per day will be measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline self-reported physical activity at 1.5 months (mid-training), at 3 months and at 9 months, respectively.</measure>
    <time_frame>Baseline, 1.5 months, 3 months, 9 months</time_frame>
    <description>Two indicator questions on physical activity from the Swedish National Board of Health and Welfare.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline metabolic health at 3 months and at 9 months, respectively.</measure>
    <time_frame>Baseline, 3 months, 9 months</time_frame>
    <description>Oral glucose tolerance test (OGTT):blood glucose in mmol/l,</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline lipid profile at 3 months and at 9 months, respectively.</measure>
    <time_frame>Baseline, 3 months, 9 months</time_frame>
    <description>Lipid profile, measured by total cholesterol as well as separately as LDL- cholesterol and HDL-cholesterol. Unit of measure is mmol/l.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline inflammation markers at 3 months and at 9 months, respectively.</measure>
    <time_frame>Baseline, 3 months, 9 months</time_frame>
    <description>C-reactive protein (CRP) in blood sample, units of measure is mg/l.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline inflammation markers at 3 months and at 9 months, respectively.</measure>
    <time_frame>Baseline, 3 months, 9 months</time_frame>
    <description>Interleukins in blood sample, units of measure is pg/ml.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline neurotrophic factors at 3 months and at 9 months, respectively.</measure>
    <time_frame>Baseline, 3 months, 9 months</time_frame>
    <description>Insulin-like growth factor 1 (IGF-1), units of measure is pg/ml.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline neurotrophic factors at 3 months and at 9 months, respectively.</measure>
    <time_frame>Baseline, 3 months, 9 months</time_frame>
    <description>Brain-derived neurotrophic factor (BDNF), units of measure is pg/ml.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline blood pressure at 1.5 months (mid-training), at 3 months and at 9 months, respectively.</measure>
    <time_frame>Baseline, 1.5 months, 3 months, 9 months</time_frame>
    <description>Blood pressure at rest, measured as systolic ans diastolic pressure in mmHg.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline resting heart rate at 1.5 months (mid-training), at 3 months and at 9 months, respectively.</measure>
    <time_frame>Baseline, 1.5 months, 3 months, 9 months</time_frame>
    <description>Resting heart rate, measured as beats per minute.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline autonomic function at 1.5 months (mid-training), at 3 months and at 9 months, respectively.</measure>
    <time_frame>Baseline, 1.5 months, 3 months, 9 months</time_frame>
    <description>Heart rate variability (HRV), measured in the time domain (e.g. RMSSD) and frequency domain (LF:HF).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Applicability of the interventions</measure>
    <time_frame>Through the whole 3-month intervention period</time_frame>
    <description>Attendance: number of sessions attended.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Applicability of the interventions</measure>
    <time_frame>Through the whole 3-month intervention period</time_frame>
    <description>Absolute work-load during training in Watt.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Applicability of the interventions</measure>
    <time_frame>Through the whole 3-month intervention period</time_frame>
    <description>Relative training intensity, as percentage of MAP (Maximum Aerobic Power output).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Applicability of the interventions</measure>
    <time_frame>Through the whole 3-month intervention period</time_frame>
    <description>Relative training intensity, as percentage of MHR (maximum heart rate).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Applicability of the interventions</measure>
    <time_frame>Through the whole 3-month intervention period</time_frame>
    <description>Perceived exertion during training, measured with the Borg Rating of perceived exertion scale (RPE)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Applicability of the interventions</measure>
    <time_frame>Through the whole 3-month intervention period</time_frame>
    <description>Adverse events, discomfort or chest pain during training measured with the Borg Category ratio scale (CR-10).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Applicability of the interventions</measure>
    <time_frame>Through the whole 3-month intervention period</time_frame>
    <description>Affective state during training session using Feeling Scale, range -5 to 5, higher score indicates better feeling.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Experiences of exercising and its effects</measure>
    <time_frame>3 months, 9 months.</time_frame>
    <description>Focus group interviews.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">68</enrollment>
  <condition>Aged</condition>
  <arm_group>
    <arm_group_label>High-intensity training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each high-intensity training (HIT) session will consist of 10 repeated 6-seconds regulated high intensity cycling sprints against an individualized load set to reach a supramaximal exercise intensity (i.e. power output is higher than power output at maximum oxygen uptake). Session duration for HIT is 20 min, including warm-up and cool-down. The protocol enables controlled and systematic adjustments of training intensity by means of standardized criteria.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Moderate-intensity continuous training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Each moderate-intensity continuous training (MICT) session will consist of aerobic training regulated against an individualized load set to reach a moderate submaximal exercise intensity (i.e. power output is lower than power output at maximum oxygen uptake). Session duration for MICT is 40 min, including warm-up and cool-down. The protocol enables controlled and systematic adjustments of training intensity by means of standardized criteria.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>High-intensity training</intervention_name>
    <description>Sessions will be performed twice weekly for 12 weeks, in groups of 8-10 participants and two supervisors.</description>
    <arm_group_label>High-intensity training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Moderate-intensity continuous training</intervention_name>
    <description>Sessions will be performed twice weekly for 12 weeks, in groups of 8-10 participants and two supervisors.</description>
    <arm_group_label>Moderate-intensity continuous training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Not regularly physically active at moderate or high intensity over the last year.&#xD;
&#xD;
          -  Independent in activities of daily living (ADL) and able to transfer from home to&#xD;
             exercise facility.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chronic and progressive neurological diseases.&#xD;
&#xD;
          -  Movement related conditions and functions (e.g. pain) or heart and lung conditions and&#xD;
             diseases that prohibit exercise or tests, based on screening by a physician.&#xD;
&#xD;
          -  Cognitive impairment (Mini-Mental State Examination score below 27)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Erik Rosendahl, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Umeå University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Carl-Johan Boraxbekk, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Umeå University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Umeå University</name>
      <address>
        <city>Umeå</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>October 2, 2020</last_update_submitted>
  <last_update_submitted_qc>October 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Aged</keyword>
  <keyword>Aged, 80 and over</keyword>
  <keyword>Exercise</keyword>
  <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/NCT03765385
org study id: Dnr 2018-307-31M
nct id: NCT03765385
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This randomized controlled trial will evaluate the effect of high-intensity training (HIT) in
      older sedentary people. Seventy older people, aged 65 and over, will be randomized to HIT or
      moderate-intensity continuous training (MICT). HIT sessions will consist of 10 repeated
      6-seconds regulated high intensity cycling sprints against an individualized load. MICT
      (control group) sessions will consist of aerobic training regulated against an individualized
      load set to reach a moderate submaximal exercise intensity. Both groups will be performed
      twice weekly for 12 weeks. The study will evaluate the effects on 1) Cardiovascular function,
      2) Brain health, 3) Muscular function, 4) Psychological health, 5) Physical activity, 6)
      Metabolic health, and 7) Examine the feasibility (attendance, achieved intensity, adverse
      events) as well as the experiences of HIT. Most outcomes will be assessed at baseline, 3
      months (directly after intervention period), and 9 months by blinded assessors.
Information about modifications of the study protocol (September 2020): Experiences of
      exercising and its effects were at the 9-month follow-up collected through individual
      interviews instead of focus group interviews (secondary outcome measures no. 31). Due to
      Covid-19, at the 9-month follow-up all outcome measurements besides the questionnaire
      (secondary outcome measures no 9, 10, 11, 12, and 14) and interviews (secondary outcome
      measure no 31) were terminated for 37 of the participants.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
masking description: The outcome assessors will be masked to group allocation. The participants will be given repeated instructions not to reveal their group allocation to the outcome assessors. Data set will be blinded regarding group allocation (and the code for the groups will be held by a researcher not involved in the study) when performing analyses for main outcomes.
measure: Change from baseline cardiovascular capacity at 3 months and at 9 months, respectively.
time frame: Baseline, 3 months, 9 months
description: Maximum oxygen uptake (VO2 max)
measure: Change from baseline cognitive function at 3 months and at 9 months, respectively.
time frame: Baseline, 3 months, 9 months
description: Measured using standardized tests covering: episodic memory (free recall, paired associates), executive functions (n-back, Trail Making Test (TMT) 4, flanker task), visuospatial ability (spatial relations), working memory (digit span) and processing speed (Trail Making Test (TMT) 2 and 3). The cognitive tasks are first z-transformed and then everaged to form a unit-weighted cognitive score as well as domain specific constructs.
measure: Change from baseline brain function at 3 months.
time frame: Baseline, 3 months
description: Assessed using functional MRI (fMRI) using two paradigms. Test A will estimate functional brain response during working memory manipulation and maintenance. Test B will estimate brain response during a pattern completion/separation paradigm. Separate analyses will be performed for fMRI paradigm A and B respectively. For each paradigm changes of % signal BOLD change will be analysed.
measure: Change from baseline brain structure at 3 months.
time frame: Baseline, 3 months
description: Assessed using standard MRI-sequences including T1w, T2w, T2-FLAIR. For structural MRI data volume (mm3) and cortical thickness (mm) will be the unit of measure.
measure: Change from baseline strength in knee extensors at 3 months and at 9 months, respectively.
time frame: Baseline, 3 months, 9 months
description: Maximal isometric strength in knee extensor measured as normalized joint torque in newton meters per kilogram bodyweight (Nm/kg).
measure: Change from baseline hand grip strength at 3 months and at 9 months, respectively.
time frame: Baseline, 3 months, 9 months
description: Maximal hand grip strength measured as normalized force in Newtons per kilogram bodyweight (N/kg).
measure: Change from baseline leg extensor muscle power at 3 months and at 9 months, respectively.
time frame: Baseline, 3 months, 9 months
description: Leg extensor power in the Nottingham Power Rig, measured as peak power output (watt).
measure: Change from baseline functional performance at 3 months and at 9 months, respectively.
time frame: Baseline, 3 months, 9 months
description: Chair-stand test, number of chair-stands during 30 seconds.
measure: Change from baseline functional balance at 3 months and at 9 months, respectively.
time frame: Baseline, 3 months, 9 months
description: One-leg stance: number of seconds able to stand on one leg (maximum 120 seconds).
measure: Change from baseline functional balance at 3 months and at 9 months, respectively.
time frame: Baseline, 3 months, 9 months
description: Step test, number of steps during 30 seconds.
measure: Change from baseline anxiety and depression at 3 months and at 9 months, respectively.
time frame: Baseline, 3 months, 9 months
description: Hospital anxiety and depression scale (HAD): range 0-42, higher score indicates more symptoms.
measure: Change from baseline health related quality of life at 3 months and at 9 months, respectively.
time frame: Baseline, 3 months, 9 months
description: Short Form Health Survey (SF-36): scores transformed to 0 to 100, higher scores indicates better quality of life.
measure: Change from baseline self-efficacy at 3 months and at 9 months, respectively.
time frame: Baseline, 3 months, 9 months
description: Swedish Exercise Self Efficacy Scale (ESES-S): Range 10-40, higher score indicates more self efficacy.
measure: Change from baseline sleep quality at 3 months and at 9 months, respectively.
time frame: Baseline, 3 months, 9 months
description: One question (no. 3) regarding sleep from Montgomery-Åsberg Depression Rating Scale (MADRS).
measure: Change from baseline objective physical activity at 1.5 months (mid-training), at 3 months and at 9 months, respectively.
time frame: Baseline, 1.5 months, 3 months, 9 months
description: Physical activity measured by an activity monitor, the Actigraph. Number of steps per day and number of activity counts per day will be measured.
measure: Change from baseline self-reported physical activity at 1.5 months (mid-training), at 3 months and at 9 months, respectively.
time frame: Baseline, 1.5 months, 3 months, 9 months
description: Two indicator questions on physical activity from the Swedish National Board of Health and Welfare.
measure: Change from baseline metabolic health at 3 months and at 9 months, respectively.
time frame: Baseline, 3 months, 9 months
description: Oral glucose tolerance test (OGTT):blood glucose in mmol/l,
measure: Change from baseline lipid profile at 3 months and at 9 months, respectively.
time frame: Baseline, 3 months, 9 months
description: Lipid profile, measured by total cholesterol as well as separately as LDL- cholesterol and HDL-cholesterol. Unit of measure is mmol/l.
measure: Change from baseline inflammation markers at 3 months and at 9 months, respectively.
time frame: Baseline, 3 months, 9 months
description: C-reactive protein (CRP) in blood sample, units of measure is mg/l.
measure: Change from baseline inflammation markers at 3 months and at 9 months, respectively.
time frame: Baseline, 3 months, 9 months
description: Interleukins in blood sample, units of measure is pg/ml.
measure: Change from baseline neurotrophic factors at 3 months and at 9 months, respectively.
time frame: Baseline, 3 months, 9 months
description: Insulin-like growth factor 1 (IGF-1), units of measure is pg/ml.
measure: Change from baseline neurotrophic factors at 3 months and at 9 months, respectively.
time frame: Baseline, 3 months, 9 months
description: Brain-derived neurotrophic factor (BDNF), units of measure is pg/ml.
measure: Change from baseline blood pressure at 1.5 months (mid-training), at 3 months and at 9 months, respectively.
time frame: Baseline, 1.5 months, 3 months, 9 months
description: Blood pressure at rest, measured as systolic ans diastolic pressure in mmHg.
measure: Change from baseline resting heart rate at 1.5 months (mid-training), at 3 months and at 9 months, respectively.
time frame: Baseline, 1.5 months, 3 months, 9 months
description: Resting heart rate, measured as beats per minute.
measure: Change from baseline autonomic function at 1.5 months (mid-training), at 3 months and at 9 months, respectively.
time frame: Baseline, 1.5 months, 3 months, 9 months
description: Heart rate variability (HRV), measured in the time domain (e.g. RMSSD) and frequency domain (LF:HF).
measure: Applicability of the interventions
time frame: Through the whole 3-month intervention period
description: Attendance: number of sessions attended.
measure: Applicability of the interventions
time frame: Through the whole 3-month intervention period
description: Absolute work-load during training in Watt.
measure: Applicability of the interventions
time frame: Through the whole 3-month intervention period
description: Relative training intensity, as percentage of MAP (Maximum Aerobic Power output).
measure: Applicability of the interventions
time frame: Through the whole 3-month intervention period
description: Relative training intensity, as percentage of MHR (maximum heart rate).
measure: Applicability of the interventions
time frame: Through the whole 3-month intervention period
description: Perceived exertion during training, measured with the Borg Rating of perceived exertion scale (RPE)
measure: Applicability of the interventions
time frame: Through the whole 3-month intervention period
description: Adverse events, discomfort or chest pain during training measured with the Borg Category ratio scale (CR-10).
measure: Applicability of the interventions
time frame: Through the whole 3-month intervention period
description: Affective state during training session using Feeling Scale, range -5 to 5, higher score indicates better feeling.
measure: Experiences of exercising and its effects
time frame: 3 months, 9 months.
description: Focus group interviews.
arm group label: High-intensity training
arm group type: Experimental
description: Each high-intensity training (HIT) session will consist of 10 repeated 6-seconds regulated high intensity cycling sprints against an individualized load set to reach a supramaximal exercise intensity (i.e. power output is higher than power output at maximum oxygen uptake). Session duration for HIT is 20 min, including warm-up and cool-down. The protocol enables controlled and systematic adjustments of training intensity by means of standardized criteria.
arm group label: Moderate-intensity continuous training
arm group type: Active Comparator
description: Each moderate-intensity continuous training (MICT) session will consist of aerobic training regulated against an individualized load set to reach a moderate submaximal exercise intensity (i.e. power output is lower than power output at maximum oxygen uptake). Session duration for MICT is 40 min, including warm-up and cool-down. The protocol enables controlled and systematic adjustments of training intensity by means of standardized criteria.
intervention type: Other
intervention name: High-intensity training
description: Sessions will be performed twice weekly for 12 weeks, in groups of 8-10 participants and two supervisors.
arm group label: High-intensity training
intervention type: Other
intervention name: Moderate-intensity continuous training
description: Sessions will be performed twice weekly for 12 weeks, in groups of 8-10 participants and two supervisors.
arm group label: Moderate-intensity continuous training
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Erik Rosendahl, Professor
role: Principal Investigator
affiliation: Umeå University
last name: Carl-Johan Boraxbekk, Professor
role: Principal Investigator
affiliation: Umeå University
facility: 
country: Sweden
responsible party type: Sponsor
sharing ipd: Undecided