The Effect of the High-intensity Resistance Training in COPD Patients Recovering From Hospital Exacerbation: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Dyspnea during daily activities measured by the Barthel Dyspnea Index (BDI)
研究概览
简要总结
After a COPD exacerbation, many individuals experience severe weakness in the leg muscles, especially the quadriceps. This weakness can make daily activities difficult and slow down recovery. Traditional respiratory rehabilitation usually focuses on endurance training, which is effective but often hard to tolerate soon after an exacerbation due to persistent symptoms and limited functional capacity.
This study aims to compare two early rehabilitation approaches during recovery from a COPD exacerbation: a maximal strength training (MST) programme using high loads and few repetitions, and a traditional endurance-based training programme.
The investigators aim to determine whether MST is easier to tolerate, especially in terms of breathlessness, and whether MST can improve muscle strength, efficiency, and overall exercise tolerance as well as or better than endurance training.
The results will help identify the most suitable rehabilitation strategy for individuals recovering from a COPD exacerbation, particularly for those who struggle with high-intensity endurance exercise.
详细描述
Background
Exacerbations of chronic obstructive pulmonary disease (COPD) represent critical events in the disease trajectory, significantly increasing mortality, hospital readmissions, and reducing quality of life. Following an exacerbation, affected individuals frequently experience higher symptoms and functional decline, which may be either reversible or not.
Individuals recovering from COPD exacerbations often face profound peripheral muscle weakness, particularly in the quadriceps. This is attributed to systemic inflammation, corticosteroid use, chronic inactivity, and nutritional deficits during acute phases.
Current international guidelines advocate for pulmonary rehabilitation (PR) during the post-acute recovery phase of COPD. These programmes integrate exercise training, self-management education, psychological support, and pharmacological optimization. PR programmes must be tailored to each participant's clinical conditions, comorbidities, and needs.
The ideal timing of PR initiation after an acute exacerbation of COPD remains debated. Some evidence shows that early rehabilitation involving endurance training during hospitalization did not reduce readmission rates nor improve long-term physical capacity, and was associated with increased mortality at 12 months, compared to delayed PR. Consequently, guidelines recommend starting PR within three weeks after discharge from acute hospital care to mitigate any risk associated with early initiation during the acute phase.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •COPD diagnosis according to the GOLD guidelines [11] with FEV1/FVC <70%
- •Stable clinical condition (pH>7.30) [11]
- •Hospital discharge within 3 weeks from an event of hospitalization due to an acute exacerbation of COPD.
- •Absence of significant motor disability, described by the possibility of performing the 6MWT.
排除标准
- •Presence of lung diseases other than COPD
- •Orthopedic and neurological conditions that prevent the execution of functional tests
- •Severe neurological and cardiologic comorbidities or other severe diseases compromise exercise tolerance.
- •Cognitive impairment evaluated by Mini-Mental State Examination (MMSE) score as < 25.
结局指标
主要结局
Dyspnea during daily activities measured by the Barthel Dyspnea Index (BDI)
时间窗: From the date of randomization to the End of the program (up to 3 weeks)
Dyspnea (breathlessness) during routine daily activities will be measured using the Barthel Dyspnea Index (0-100; higher scores indicate greater dyspnea), a questionnaire that evaluates the severity of shortness of breath during common tasks such as walking, dressing, climbing stairs, and bathing. Each activity is scored, and higher scores indicate greater difficulty or breathlessness. The assessment is performed through patient self-report with guidance from a trained clinician. This measure provides a practical evaluation of how dyspnea affects functional independence in everyday life.
次要结局
- Distance walked on the Six-Minute Walk Test (6MWT)(From the date of randomization to the End of the program (up to 3 weeks))
- Fatigue Severity Scale (FSS) total score(From the date of randomization to the End of the program (up to 3 weeks))
- Maximal Voluntary Contraction (MVC) of isometric quadriceps voluntary strength.(From the date of randomization to the End of the program (up to 3 weeks))
- Lower Limb Strength Assessment with the 1-Repetition Maximum (1-RM) Test.(From the date of randomization to the End of the program (up to 3 weeks))
- Quadriceps pennation angle (vastus lateralis) via ultrasound scanning(From randomization to the End of the program (up to 3 weeks))
- Quadriceps muscle thickness (vastus lateralis) via ultrasound scanning(From the date of randomization to the End of the program (up to 3 weeks))
- Diaphragmatic thickness via ultrasound scanning(From the date of randomization to the End of the program (up to 3 weeks))
- Diaphragmatic excursion via ultrasound scanning(From the date of randomization to the End of the program (up to 3 weeks))
- Impact of the disease (COPD Assessment Test - CAT)(From the date of randomization to the End of the program (up to 3 weeks))
- Health-related Quality of Life (MRF-26 questionnaire)(From the date of randomization to the End of the program (up to 3 weeks))
- Maximal Voluntary Contraction (MVC)(From the date of randomization to the End of the program (up to 3 weeks))
- Electrically stimulated resting force (Qtpot)(From the date of randomization to the End of the program (up to 3 weeks))
- Maximal Voluntary Activation (MVA)(From the date of randomization to the End of the program (up to 3 weeks))
- M-wave amplitude(From the date of randomization to the End of the program (up to 3 weeks))
- Walking efficiency (Walking Energy cost).(From the date of randomization to the End of the program (up to 3 weeks))
- Acceptability and satisfaction with the training.(From the date of randomization to the End of the program (up to 3 weeks))