Blood Flow Restriction Cycling for Functional Mobility in Older Adults

NCT07825987 | Completed

• 1 other identifier: 2023_H
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Ageing

Outcome Measures

Primary Outcomes (2)

• Change in Functional Mobility (De Morton Mobility Index, DEMMI)

  Change in DEMMI interval score (range 0-100, Rasch-converted), assessed by a blinded rater.

  Baseline (T0) to post-intervention (T1, 48-72 hours after the last of 12 training sessions, approx. 6 weeks)

• Change in Health-Related Quality of Life (SF-36)

  Change across the eight domains and summary scores of the SF-36 (German version), analyzed jointly as a single co-primary outcome family.

  Baseline (T0) to post-intervention (T1, approx. 6 weeks)

Study Arms (2)

Intervention Group (INT)

EXPERIMENTAL

Participants performed 15-minute, twice-weekly low-load cycling sessions for six weeks (12 sessions total), combined with bilateral blood flow restriction using thigh cuffs individually calibrated to 60% of each participant's measured limb occlusion pressure (LOP). Exercise intensity was prescribed as an internal training load, individually matched to a target relative heart rate (percentage of heart rate reserve), with workload adjusted session-to-session as needed.

Device: Individualized Blood Flow Restriction (BFR) via Personalized Tourniquet System

Sham Comparator (CON)

ACTIVE COMPARATOR

Participants performed the identical 15-minute, twice-weekly low-load cycling protocol for six weeks (12 sessions total), with bilateral thigh cuffs applied at a fixed, non-occlusive sham pressure of 20 mmHg. Exercise intensity was prescribed identically to the intervention arm (internal training load, individually matched to target heart rate reserve)

Device: Sham Blood Flow Restriction (Fixed Low Pressure)

Interventions

Individualized Blood Flow Restriction (BFR) via Personalized Tourniquet System DEVICE

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.

Intervention Group (INT)

Sham Blood Flow Restriction (Fixed Low Pressure) DEVICE

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.

Sham Comparator (CON)

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age \> 70 years
• Community-dwelling
• Written informed consent
• Medical clearance for participation in exercise training with blood flow restriction (BFR)

You may not qualify if:

• Acute or chronic malignancy
• Immunosuppression
• Acute or chronic systemic infection
• Sickle cell anemia
• Previous vascular surgery of the lower extremities (e.g., bypass grafting or stent implantation)

Sponsors & Collaborators

• University Hospital, Bonn: lead

Study Sites (1)

Cellitinnen-Krankenhaus St. Marien

Cologne, North Rhine-Westphalia, 50668, Germany

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med., B.Sc.

Study Record Dates

• First Submitted: September 12, 2026
• First Posted: September 17, 2026
• Study Start: January 1, 2023
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: September 17, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)