Healthy Ageing
Conditions
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.
Interventions
DEVICEIndividualized 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.
DEVICESham 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.
Sponsors
University Hospital, Bonn
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 70 years * Community-dwelling * Written informed consent * Medical clearance for participation in exercise training with blood flow restriction (BFR)
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Functional Mobility (De Morton Mobility Index, DEMMI) | Baseline (T0) to post-intervention (T1, 48-72 hours after the last of 12 training sessions, approx. 6 weeks) | Change in DEMMI interval score (range 0-100, Rasch-converted), assessed by a blinded rater. |
| Change in Health-Related Quality of Life (SF-36) | Baseline (T0) to post-intervention (T1, approx. 6 weeks) | Change across the eight domains and summary scores of the SF-36 (German version), analyzed jointly as a single co-primary outcome family. |
Countries
Germany
Outcome results
None listed