Enforced Reduction in Physical Activity and Recovery in Older Adults

NCT ID: NCT04997447

Last Updated: 2023-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-15
• Study Completion Date: 2022-11-22

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.

Conditions

Muscle Degeneration; Body Weight Changes; Walking, Difficulty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Step-reduction/Exercise Rehab

Intervention Type: BEHAVIORAL

2-week limited daily steps (\<2000), and then 4 weeks of typical strength+endurance exercise for older adults

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Step-reduction/Exercise Rehab

2-week limited daily steps (\<2000), and then 4 weeks of typical strength+endurance exercise for older adults

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 70 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Eastern Finland

OTHER

Sponsor Role: collaborator

University of Jyvaskyla

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Simon Walker, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Jyväskylä, Finland

Locations

University of Jyväskylä

Jyväskylä, Central Finland, Finland

Countries

Finland

Other Identifiers

SKR:271901-36456

Identifier Type: -

Identifier Source: org_study_id