Effects of Individualized Blood Flow Restriction During Low-Load Cycling Training on Functional Mobility and Quality of Life in Community-Dwelling Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Functional Mobility (De Morton Mobility Index, DEMMI)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 70 years
- •Community-dwelling
- •Written informed consent
- •Medical clearance for participation in exercise training with blood flow restriction (BFR)
排除标准
- •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)
研究组 & 干预措施
Intervention Group (INT)
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.
干预措施: Individualized Blood Flow Restriction (BFR) via Personalized Tourniquet System (Device)
Sham Comparator (CON)
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)
干预措施: Sham Blood Flow Restriction (Fixed Low Pressure) (Device)
结局指标
主要结局
Change in Functional Mobility (De Morton Mobility Index, DEMMI)
时间窗: 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)
时间窗: 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.
次要结局
未报告次要终点
研究者
Alexander Franz
Dr. med., B.Sc.
University Hospital, Bonn