Enforced Reduction in Physical Activity and Recovery in Older Adults

NCT04997447 | Completed

• 1 other identifier: SKR:271901-36456
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Lean leg mass

  DXA-measured total lean mass of the legs

  6 weeks

Secondary Outcomes (7)

• Whole-body fat mass

  6 weeks

• Maximum isometric leg extension force

  6 weeks

• Walking economy

  6 weeks

• Short Physical Performance Battery (SPPB)

  6 weeks

• Blood pressure

  6 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

Step-reduction/Exercise Rehab BEHAVIORAL

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

Intervention group

Eligibility Criteria

• Age: 70 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Jyvaskyla: lead
• University of Eastern Finland: collaborator

Study Sites (1)

University of Jyväskylä

Jyväskylä, Central Finland, 40014, Finland

Location

MeSH Terms

Conditions

Body Weight Changes; Mobility Limitation

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Simon Walker, PhD

  University of Jyväskylä, Finland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Trial, with 2 parallel groups

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: August 9, 2021
• Study Start: September 15, 2021
• Primary Completion: December 22, 2021
• Study Completion: November 22, 2022
• Last Updated: August 21, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)