Enforced Reduction in Physical Activity and Recovery in Older Adults

Not Applicable

Completed

• Conditions: Muscle Degeneration; Body Weight Changes; Walking, Difficulty
• Interventions: Behavioral: Step-reduction/Exercise Rehab

• Registration Number: NCT04997447
• Lead Sponsor: University of Jyvaskyla

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-01
• Study First Submitted QC: 2021-08-02
• Study First Posted: 2021-08-09
• Study Start: 2021-09-15
• Primary Completion: 2021-12-22
• Study Completion: 2022-11-22
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-15
• Last Update Posted: 2023-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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,
4. MMSE >24,
5. BMI 20-35 kg·m2 (i.e. not underweight or severely obese),
6. no serious cardiovascular or musculoskeletal disease,
7. no risk factors for deep-vein thrombosis (e.g. blood clotting disorder, obesity, bowel diseases, personal or family history of DVT etc.),
8. non-smoker,
9. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Step-reduction/Exercise Rehab	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)

Primary Outcome Measures

Name	Time	Method
Lean leg mass	6 weeks	DXA-measured total lean mass of the legs

Secondary Outcome Measures

Name	Time	Method
Maximum isometric leg extension force	6 weeks	Maximum strength of legs
Short Physical Performance Battery (SPPB)	6 weeks	Walking, balance and chair-rise tests
Blood pressure	6 weeks	Systolic and diastolic blood pressure during rest (sitting)
HOMA indices	6 weeks	Blood glucose and insulin concentration based calculations related to insulin resistance and beta-cell function
White blood cell respiration	6 weeks	Isolated white blood cell respiration as a marker for mitochondrial function
Walking economy	6 weeks	Oxygen uptake while walking at 3 and 5 km.h-1
Whole-body fat mass	6 weeks	DXA-measured total body fat mass

Trial Locations

Locations (1)

University of Jyväskylä; 🇫🇮 Jyväskylä, Central Finland, Finland