ENDURE: Enforced Reduction in Physical Activity and Recovery in Older Adults

Sponsor
University of Jyvaskyla (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04997447
Collaborator
University of Eastern Finland (Other)
80
2
28

Study Details

Study Description

Brief Summary

Apparently healthy and well-functioning community dwelling 70-80 year-olds will be recruited to the study. All subjects undergo pre-screening for suitability and a physicians examination, as well as 7-day habitual daily steps are measured to ascertain baseline physical activity. Half of the recruited subjects (n=40) will be randomized into the intervention group and half (n=40) randomized into the control group. The intervention group is then required to reduce their daily steps to <2000 for a 2-week period. Thereafter, the intervention group participates to a 4-week strength+endurance training rehabilitation program and no longer has restricted daily step count. The control group continues their normal habitual physical activity level throughout the 6-week study period.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Step-reduction/Exercise Rehab
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized Controlled Trial, with 2 parallel groupsRandomized Controlled Trial, with 2 parallel groups
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Enforced Reduction in Physical Activity and Recovery in Older Adults
Anticipated Study Start Date :
Aug 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention group

Two weeks of daily step reduction (limited to 2000 steps per day) followed by four weeks of supervised gym-based exercise rehabilitation (twice per week strength training and twice per week cycle endurance training)

Behavioral: Step-reduction/Exercise Rehab
2-week limited daily steps (<2000), and then 4 weeks of typical strength+endurance exercise for older adults

No Intervention: Control group

Continued monitoring of habitual daily step count without structured intervention. Classic control.

Outcome Measures

Primary Outcome Measures

  1. Lean leg mass [6 weeks]

    DXA-measured total lean mass of the legs

Secondary Outcome Measures

  1. Whole-body fat mass [6 weeks]

    DXA-measured total body fat mass

  2. Maximum isometric leg extension force [6 weeks]

    Maximum strength of legs

  3. Walking economy [6 weeks]

    Oxygen uptake while walking at 3 and 5 km.h-1

  4. Short Physical Performance Battery (SPPB) [6 weeks]

    Walking, balance and chair-rise tests

  5. Blood pressure [6 weeks]

    Systolic and diastolic blood pressure during rest (sitting)

  6. HOMA indices [6 weeks]

    Blood glucose and insulin concentration based calculations related to insulin resistance and beta-cell function

  7. White blood cell respiration [6 weeks]

    Isolated white blood cell respiration as a marker for mitochondrial function

Eligibility Criteria

Criteria

Ages Eligible for Study:
70 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. aged 70-80 years,

  2. community-dwelling,

  3. able to walk 500 m without assistance or use of walking aid and regularly walking

5000 steps per day,

  1. MMSE >24,

  2. BMI 20-35 kg·m2 (i.e. not underweight or severely obese),

  3. no serious cardiovascular or musculoskeletal disease,

  4. no risk factors for deep-vein thrombosis (e.g. blood clotting disorder, obesity, bowel diseases, personal or family history of DVT etc.),

  5. non-smoker,

  6. provision of informed consent.

Exclusion Criteria:
  1. Underlying diseases likely to limit lifespan and/or intervention safety. Contraindication for physical exercise or physical tests identified during physician's examination,

  2. unwilling/unable to track daily step counts using accelerometer,

  3. excessive and regular use of alcohol (more than 7 units per week for women and 14 for men)

  4. difficulty in communication due to severe vision or hearing problems

  5. unwilling to provide consent or accept randomization into either study group

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Jyvaskyla
  • University of Eastern Finland

Investigators

  • Principal Investigator: Simon Walker, PhD, University of Jyväskylä, Finland

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Jyvaskyla
ClinicalTrials.gov Identifier:
NCT04997447
Other Study ID Numbers:
  • SKR:271901-36456
First Posted:
Aug 9, 2021
Last Update Posted:
Aug 9, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 9, 2021