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COMPLETED
NCT07825987
NA

Blood Flow Restriction Cycling for Functional Mobility in Older Adults

Sponsor: University Hospital, Bonn

View on ClinicalTrials.gov

Summary

This randomized, sham-controlled trial investigates whether a six-week, twice-weekly low-load cycling program combined with individualized blood flow restriction (BFR) improves functional mobility and health-related quality of life in community-dwelling adults older than 70 years, compared with identical cycling exercise without effective BFR. Blood flow restriction is applied using thigh cuffs, individually calibrated to a percentage of each participant's measured limb occlusion pressure; the control group receives cycling exercise with a fixed, low sham cuff pressure. The co-primary outcomes are functional mobility, assessed using the De Morton Mobility Index (DEMMI), and health-related quality of life, assessed using the SF-36 questionnaire. Secondary outcomes include the Timed Up and Go test, the Six-Minute Walk Test, muscular strength, body composition, endurance capacity, and cardiovascular and metabolic safety parameters.

Official title: Effects of Individualized Blood Flow Restriction During Low-Load Cycling Training on Functional Mobility and Quality of Life in Community-Dwelling Older Adults

Key Details

Gender

All

Age Range

70 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2023-01-01

Completion Date

2024-03-31

Last Updated

2026-09-17

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Individualized Blood Flow Restriction (BFR) via Personalized Tourniquet System

Bilateral thigh cuffs (Personalized Tourniquet System, Delfi Medical Innovations Inc., Vancouver, Canada) applied during cycling exercise, pressure individually calibrated to 60% of measured limb occlusion pressure.

DEVICE

Sham Blood Flow Restriction (Fixed Low Pressure)

Bilateral thigh cuffs applied identically to the intervention arm, using the same device, but set to a fixed, non-occlusive pressure of 20 mmHg rather than an individually calibrated pressure.

Locations (1)

Cellitinnen-Krankenhaus St. Marien

Cologne, North Rhine-Westphalia, Germany