Enforced Reduction in Physical Activity and Recovery in Older Adults

Body Weight Changes Clinical Trial

— ENDURE  

Official title:

Enforced Reduction in Physical Activity and Recovery in Older Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04997447
• Other study ID #: SKR:271901-36456
• Status: Completed
• Phase: N/A
• Start date: September 15, 2021
• Est. completion date: November 22, 2022

Study information

• Verified date: August 2023
• Source: University of Jyvaskyla
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: November 22, 2022
• Est. primary completion date: December 22, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Body Weight Changes
• Mobility Limitation
• Muscle Degeneration
• Walking, Difficulty

Intervention

Behavioral:
• Step-reduction/Exercise Rehab
2-week limited daily steps (<2000), and then 4 weeks of typical strength+endurance exercise for older adults

Locations

Country	Name	City	State
Finland	University of Jyväskylä	Jyväskylä	Central Finland

Sponsors (2)

Lead Sponsor	Collaborator
University of Jyvaskyla	University of Eastern Finland

Country where clinical trial is conducted

Finland, 

Outcome

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