Back to resultsEnforced Reduction in Physical Activity and Recovery in Older Adults (ENDURE)
Primary Purpose
Muscle Degeneration, Body Weight Changes, Walking, Difficulty
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Step-reduction/Exercise Rehab
Sponsored by
About this trial
This is an interventional basic science trial for Muscle Degeneration
Eligibility Criteria
Inclusion Criteria:
- aged 70-80 years,
- community-dwelling,
- able to walk 500 m without assistance or use of walking aid and regularly walking >5000 steps per day,
- MMSE >24,
- BMI 20-35 kg·m2 (i.e. not underweight or severely obese),
- no serious cardiovascular or musculoskeletal disease,
- no risk factors for deep-vein thrombosis (e.g. blood clotting disorder, obesity, bowel diseases, personal or family history of DVT etc.),
- non-smoker,
- provision of informed consent.
Exclusion Criteria:
- Underlying diseases likely to limit lifespan and/or intervention safety. Contraindication for physical exercise or physical tests identified during physician's examination,
- unwilling/unable to track daily step counts using accelerometer,
- excessive and regular use of alcohol (more than 7 units per week for women and 14 for men)
- difficulty in communication due to severe vision or hearing problems
- unwilling to provide consent or accept randomization into either study group
Sites / Locations
- University of Jyväskylä
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Control group
Arm Description
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)
Continued monitoring of habitual daily step count without structured intervention. Classic control.
Outcomes
Primary Outcome Measures
Lean leg mass
DXA-measured total lean mass of the legs
Secondary Outcome Measures
Whole-body fat mass
DXA-measured total body fat mass
Maximum isometric leg extension force
Maximum strength of legs
Walking economy
Oxygen uptake while walking at 3 and 5 km.h-1
Short Physical Performance Battery (SPPB)
Walking, balance and chair-rise tests
Blood pressure
Systolic and diastolic blood pressure during rest (sitting)
HOMA indices
Blood glucose and insulin concentration based calculations related to insulin resistance and beta-cell function
White blood cell respiration
Isolated white blood cell respiration as a marker for mitochondrial function
Full Information
NCT ID
NCT04997447
First Posted
July 1, 2021
Last Updated
August 15, 2023
Sponsor
University of Jyvaskyla
Collaborators
University of Eastern Finland
1. Study Identification
Unique Protocol Identification Number
NCT04997447
Brief Title
Enforced Reduction in Physical Activity and Recovery in Older Adults
Acronym
ENDURE
Official Title
Enforced Reduction in Physical Activity and Recovery in Older Adults
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
September 15, 2021 (Actual)
Primary Completion Date
December 22, 2021 (Actual)
Study Completion Date
November 22, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Jyvaskyla
Collaborators
University of Eastern Finland
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Degeneration, Body Weight Changes, Walking, Difficulty
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial, with 2 parallel groups
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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)
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Continued monitoring of habitual daily step count without structured intervention. Classic control.
Intervention Type
Behavioral
Intervention Name(s)
Step-reduction/Exercise Rehab
Intervention Description
2-week limited daily steps (<2000), and then 4 weeks of typical strength+endurance exercise for older adults
Primary Outcome Measure Information:
Title
Lean leg mass
Description
DXA-measured total lean mass of the legs
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Whole-body fat mass
Description
DXA-measured total body fat mass
Time Frame
6 weeks
Title
Maximum isometric leg extension force
Description
Maximum strength of legs
Time Frame
6 weeks
Title
Walking economy
Description
Oxygen uptake while walking at 3 and 5 km.h-1
Time Frame
6 weeks
Title
Short Physical Performance Battery (SPPB)
Description
Walking, balance and chair-rise tests
Time Frame
6 weeks
Title
Blood pressure
Description
Systolic and diastolic blood pressure during rest (sitting)
Time Frame
6 weeks
Title
HOMA indices
Description
Blood glucose and insulin concentration based calculations related to insulin resistance and beta-cell function
Time Frame
6 weeks
Title
White blood cell respiration
Description
Isolated white blood cell respiration as a marker for mitochondrial function
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
aged 70-80 years,
community-dwelling,
able to walk 500 m without assistance or use of walking aid and regularly walking >5000 steps per day,
MMSE >24,
BMI 20-35 kg·m2 (i.e. not underweight or severely obese),
no serious cardiovascular or musculoskeletal disease,
no risk factors for deep-vein thrombosis (e.g. blood clotting disorder, obesity, bowel diseases, personal or family history of DVT etc.),
non-smoker,
provision of informed consent.
Exclusion Criteria:
Underlying diseases likely to limit lifespan and/or intervention safety. Contraindication for physical exercise or physical tests identified during physician's examination,
unwilling/unable to track daily step counts using accelerometer,
excessive and regular use of alcohol (more than 7 units per week for women and 14 for men)
difficulty in communication due to severe vision or hearing problems
unwilling to provide consent or accept randomization into either study group
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon Walker, PhD
Organizational Affiliation
University of Jyväskylä, Finland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Jyväskylä
City
Jyväskylä
State/Province
Central Finland
ZIP/Postal Code
40014
Country
Finland
12. IPD Sharing Statement
Plan to Share IPD
No
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Enforced Reduction in Physical Activity and Recovery in Older Adults
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