Enforced Reduction in Physical Activity and Recovery in Older Adults (ENDURE)

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.

Study Overview

• Status: Completed
• Conditions: Body Weight Changes; Walking, Difficulty; Muscle Degeneration
• Intervention / Treatment: Behavioral: Step-reduction/Exercise Rehab

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Central Finland
    • Jyväskylä, Central Finland, Finland, 40014
      • University of Jyväskylä

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years to 80 years (Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Behavioral: Step-reduction/Exercise Rehab; 2-week limited daily steps (<2000), and then 4 weeks of typical strength+endurance exercise for older adults
No Intervention: Control group; Continued monitoring of habitual daily step count without structured intervention. Classic control.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lean leg mass	DXA-measured total lean mass of the legs	6 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Jyvaskyla
• Collaborators: University of Eastern Finland
• Investigators: Principal Investigator: Simon Walker, PhD, University of Jyväskylä, Finland

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2021
• Primary Completion (Actual): December 22, 2021
• Study Completion (Actual): November 22, 2022

Study Registration Dates

• First Submitted: July 1, 2021
• First Submitted That Met QC Criteria: August 2, 2021
• First Posted (Actual): August 9, 2021

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 15, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Mobility Limitation
• Other Study ID Numbers: SKR:271901-36456

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No