Clinical trial NCT04997447: Enforced Reduction in Physical Activity and Recovery in Older Adults
Official title: Enforced Reduction in Physical Activity and Recovery in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Degeneration
Body Weight Changes
Walking, Difficulty
Lead sponsor: University of Jyvaskyla
Sponsor class: OTHER
Collaborators: name: University of Eastern Finland
First posted: 2021-08-09
Enrollment: 66
Sex: ALL
Minimum age (years): 70
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial, with 2 parallel groups
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Lean leg mass
timeFrame: 6 weeks
Secondary outcomes:
measure: Whole-body fat mass
timeFrame: 6 weeks
measure: Maximum isometric leg extension force
timeFrame: 6 weeks
measure: Walking economy
timeFrame: 6 weeks
measure: Short Physical Performance Battery (SPPB)
timeFrame: 6 weeks
measure: Blood pressure
timeFrame: 6 weeks
measure: HOMA indices
timeFrame: 6 weeks
measure: White blood cell respiration
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Jyväskylä
country: Finland
facility: University of Jyväskylä
state: Central Finland
Study officials:
affiliation: University of Jyväskylä, Finland
name: Simon Walker, PhD
role: PRINCIPAL_INVESTIGATOR
References: