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OpenTrials
Completed

NCT Number: NCT07825987

Blood Flow Restriction Cycling for Functional Mobility in Older Adults

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.

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Key information

Conditions

Healthy Ageing

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cellitinnen-Krankenhaus St. Marien

Cologne, North Rhine-Westphalia, 50668, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in Functional Mobility (De Morton Mobility Index, DEMMI)

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Bonn

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 17, 2026
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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