Effects Of Low-Load Blood Flow Restriction Training Of The Upper Extremity In Patients With Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Upper Extremity Functional Capacity
研究概览
简要总结
Chronic Obstructive Pulmonary Disease (COPD) is characterized by persistent airflow limitation, progressive dyspnea, and peripheral muscle dysfunction, significantly impairing functional capacity and quality of life. Although the combined implementation of aerobic and resistance exercises is recommended in pulmonary rehabilitation programs, early-onset ventilatory limitation in individuals with COPD often hinders tolerance to high exercise intensities. This limitation increases the need for alternative exercise approaches targeting peripheral muscle adaptations. Low-load blood flow restriction training (LL-BFRT), which enables improvements in muscle strength with low mechanical loads, has emerged as a potential option for this patient population. However, evidence regarding the effects of LL-BFRT in individuals with COPD-particularly on upper extremity muscles-remains limited.
The aim of this study is to comparatively investigate the effects of LL-BFRT and sham-BFRT, both administered in addition to an aerobic exercise program in individuals diagnosed with stage II and III COPD, on upper extremity muscle strength, upper extremity functional capacity, activities of daily living performance, quality of life, functional exercise capacity, muscle oxygenation, and respiratory parameters. The study is designed as a randomized controlled, single-blind, quasi-experimental interventional trial.
The expected outcomes are that LL-BFRT may enhance upper extremity muscle strength and functional capacity, improve activities of daily living and quality of life, and increase exercise tolerance due to its applicability at low mechanical loads. Furthermore, findings related to muscle oxygenation and respiratory parameters are anticipated to provide clinical evidence regarding the physiological effects of LL-BFRT on peripheral muscle adaptations. These results are expected to guide the integration of LL-BFRT as an alternative and safe approach in upper extremity exercise prescription within pulmonary rehabilitation programs, support clinical decision-making processes, and establish a scientific foundation for future research.
详细描述
Chronic Obstructive Pulmonary Disease (COPD) is a common, preventable, and treatable disease characterized by persistent respiratory symptoms and irreversible airflow limitation resulting from airway and/or alveolar abnormalities, usually caused by prolonged exposure to noxious particles or gases (1). COPD represents one of the leading causes of mortality among chronic respiratory diseases and is recognized as a major global health problem, affecting approximately 10% of the adult population, with an increasing incidence associated with population aging. According to the 2017 Global Burden of Disease (GBD) Study, the global mortality rate attributable to COPD was 41.9 deaths per 100,000 population, accounting for 5.7% of all-cause mortality. The mortality rate was reported as 46.7 per 100,000 in men and 37.0 per 100,000 in women (2).
The progressive and persistent airflow limitation in COPD, together with reduced parenchymal elasticity, increases ventilatory demand and imposes an excessive load on the respiratory muscles. Hyperinflation further reduces the effective contractile range of these muscles, creating a vicious cycle in which mechanoreceptor stimulation enhances ventilatory drive and exacerbates dyspnea. Increased dyspnea and impaired respiratory muscle function limit the performance of activities of daily living (ADLs), leading to substantial reductions in physical performance (3).
Skeletal muscle dysfunction is a frequent systemic manifestation of COPD. Reductions in peripheral muscle strength involving the upper and lower extremities as well as the trunk significantly limit exercise capacity and functional performance, negatively affecting overall health status. Importantly, impaired muscle strength has been identified as a strong predictor of morbidity, mortality, disability, and exacerbation risk, independent of the degree of airway obstruction (4).
During upper extremity activities, individuals with COPD frequently experience marked dyspnea and dynamic hyperinflation, which significantly restrict functional independence and highlight the clinical importance of upper extremity functional capacity (5). Compared with healthy peers, individuals with COPD demonstrate reduced performance during upper limb activities and report substantial difficulty. This limitation is partly attributable to altered respiratory mechanics, as upper extremity muscles also function as accessory respiratory muscles. Consequently, dyspnea intensifies during upper limb activity, often leading to premature termination of exercise (6).
Given the dyspnea-inducing nature of upper extremity use and its negative impact on activity tolerance, preserving and improving upper extremity function constitutes a critical rehabilitation target in COPD. Indeed, as emphasized in the most recent joint official statement by the American Thoracic Society (ATS) and the European Respiratory Society (ERS), the inclusion of upper extremity exercise training in pulmonary rehabilitation programs is strongly supported for individuals with COPD (7).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
This study is designed as a single-blind randomized controlled trial. Participants will be blinded to group allocation. Both the intervention (LL-BFRT) and control (sham-BFRT) groups will receive identical exercise protocols in terms of frequency, duration, targeted muscle groups, and set-repetition structure. In the sham-BFRT group, cuff pressure will be applied at a level insufficient to produce therapeutic blood flow restriction. Participants will not be informed whether the applied cuff pressure represents an active or sham intervention
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals aged 40-80 years with stage 2 and 3 COPD diagnosed according to GOLD criteria
- •Clinically stable COPD (no exacerbation in the last 6 weeks)
- •Stable medical treatment for at least 4 weeks
- •No orthopedic or neurological problems that would prevent them from performing upper extremity exercises
- •Resting SpO2 ≥ 88%
- •Able to understand and follow verbal instructions in Turkish
- •Individuals with a Montreal Cognitive Assessment Scale (MoCa) score ≥ 24 will be included.
排除标准
- •Uncontrolled hypertension
- •Severe arrhythmia
- •Recent MI
- •Deep vein thrombosis
- •Peripheral vascular disease
- •Presence of infection or open wound
- •Having undergone upper extremity surgery within the last 6 months
- •Cognitive impairment or cooperation problems will be among the exclusion criteria
研究组 & 干预措施
Intervention Group
Participants will receive an 8-week upper extremity aerobic exercise program combined with low-load blood flow restriction training targeting upper extremity muscles.
干预措施: Low-Load Blood Flow Restriction Training (LL-BFRT) + Aerobic Exercise (Other)
Control Group
Participants will receive the same 8-week upper extremity aerobic exercise program combined with sham blood flow restriction training with non-therapeutic cuff pressure.
干预措施: Sham Low-Load Blood Flow Restriction Training (LL-BFRT) + Aerobic Exercise (Other)
结局指标
主要结局
Upper Extremity Functional Capacity
时间窗: Pre- and post-intervention (week 8).
Upper extremity functional capacity and endurance will be assessed using the 6-Minute Pegboard \& Ring Test (6-PBRT). During the test, participants will be seated in front of a pegboard and instructed to use both hands simultaneously to transfer as many rings as possible from two lower pegboards positioned at shoulder level to two upper pegboards located 20 cm above, and then back to the lower boards. The test duration is 6 minutes. Prior to the actual test, participants will be allowed to practice by transferring a few rings to familiarize themselves with the procedure. During the test, the physiotherapist will provide standardized verbal encouragement every minute to motivate the participant. At the end of the 6 minutes, the total number of rings transferred throughout the test will be recorded as the final score (16).
次要结局
- Pulmonary Function Assessment(Pre- and post-intervention (week 8).)
- Muscle Strength Assestment(Pre-post ıntervention (week 8))
- Activity Of Daily Living Assestment(Pre-post ıntervention (week 8))
- Quality Of Life Assestment(Pre-post ıntervention (week 8))
- Functional Capacity(Pre-post ıntervention (week 8))
- Muscle Oxygenation Measurement(Pre-post ıntervention (week 8))
研究者
Zeynal Yasacı
Doctor Lecturer
Inonu University