Evaluation of the Floor-Lift Series (FLS) Pulmonary Rehabilitation Program on Short- and Long-Term Clinical and Functional Outcomes in COPD by Program Adherence: A Single-Center Quasi-Experimental Study in a North African Setting
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Adherence rate to the Floor-Lift Series (FLS) program
研究概览
简要总结
Chronic Obstructive Pulmonary Disease (COPD) is a major cause of morbidity and functional disability, with pulmonary rehabilitation (PR) representing one of the most effective non-pharmacological interventions. However, access to conventional PR programs remains extremely limited in many regions, particularly in North Africa, where resources, infrastructure, and patient adherence pose major challenges.
The Floor-Lift Series (FLS) program was developed as a culturally adapted, equipment-free, and low-cost PR alternative. It is based on progressive floor-to-stand transitions - movements deeply integrated into daily routines and familiar in the local cultural context - to enhance feasibility and adherence.
This prospective quasi-experimental study will evaluate both the short-term and long-term effects of the FLS program in COPD patients with baseline muscle dysfunction limiting their ability to rise from the floor. The short-term phase involves a 9-week intervention combining supervised and home-based training in three progressive stages (initial, intermediate, and consolidation). The long-term phase includes follow-up assessments at 18 months to evaluate sustained adherence and maintenance of clinical and functional improvements.
The primary outcome is the completion rate, defined as achieving ≥22 daily floor-lift repetitions during the final intervention phase and maintaining adherence at long-term follow-ups. Secondary outcomes include changes in dyspnea (mMRC), exertional effort (Borg CR10), disease impact (CAT), mobility (Timed Up and Go), flexibility (fingertip-to-floor distance), exercise capacity (6-minute walk test and 1-minute sit-to-stand test), and the composite BODE index.
Safety and psychosocial factors influencing adherence will be monitored throughout the study. The trial aims to provide evidence for a scalable, culturally relevant rehabilitation model for COPD management in resource-limited settings.
详细描述
This prospective, single-center, quasi-experimental longitudinal study will be conducted at the Department of Pulmonology, Ali Ben Deghine Hospital, Laghouat, Algeria. The study will include adult patients with confirmed COPD (according to GOLD 2023 criteria: post-bronchodilator FEV1/FVC <0.7 and compatible clinical symptoms such as dyspnea or chronic cough) presenting with muscle weakness or difficulty rising from the floor. Participants will be recruited consecutively during outpatient consultations and will provide written informed consent before enrollment.
Intervention Description The Floor-Lift Series (FLS) is a 9-week progressive training program designed to strengthen lower-limb and core muscles through repeated floor-to-stand transitions.
- Initial phase (Weeks 1-3): Supervised and home-based training, 7-15 repetitions/day, using wall or chair support.
- Intermediate phase (Weeks 4-6): 15-22 repetitions/day, mainly home-based practice with telephonic follow-up.
- Consolidation phase (Weeks 7-9): 22 repetitions/day, performed independently at home.
Participants are instructed on safety measures and encouraged to integrate the exercises into daily routines. Telephone follow-ups ensure adherence and detect adverse events.
Follow-up and Assessments Evaluations will be performed at baseline, after 9 weeks, and at 18 month follow-ups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Confirmed diagnosis of Chronic Obstructive Pulmonary Disease (COPD) according to GOLD 2023 criteria (post-bronchodilator FEV1/FVC <0.7 and compatible clinical symptoms such as dyspnea or chronic cough) .
- •Presence of muscle dysfunction limiting or complicating the ability to rise from the floor.
- •Clinically stable condition (no COPD exacerbation within the past 8 weeks).
- •Provided written informed consent.
排除标准
- •Acute COPD exacerbation or hospitalization within the previous 8 weeks.
- •Recent myocardial infarction, unstable angina, or decompensated heart failure.
- •Severe neurological, orthopedic, or rheumatologic condition preventing safe floor exercise.
- •Cognitive impairment interfering with understanding or cooperation.
- •Refusal or withdrawal of informed consent.
结局指标
主要结局
Adherence rate to the Floor-Lift Series (FLS) program
时间窗: At 9 weeks (end of intervention), and 18 months after program initiation.
Adherence to the Floor-Lift Series (FLS) pulmonary rehabilitation program will be defined as meeting the target of 22 floor-to-stand transitions (FLS) per day during the consolidation phase (weeks 7-9). The primary outcome will be the proportion of participants who reach this adherence criterion at the end of the 9-week program. The same adherence criterion will be reassessed at 18 months to evaluate long-term maintenance. Higher adherence rates indicate better engagement with the program and greater feasibility of sustained implementation.
次要结局
- Change in perceived exertion (modified Borg Category-Ratio 10 Scale, CR10)(Baseline, 3 weeks, 6 weeks, 9 weeks, and 18 months.)
- Change in dyspnea severity (modified Medical Research Council Dyspnea Scale, mMRC)(Baseline, 3 weeks, 6 weeks, 9 weeks, and 18 months.)
- Change in disease impact (COPD Assessment Test, CAT)(Baseline, 9 weeks, and 18 months.)
- Change in mobility (Timed Up-and-Go test, TUG)(Baseline, 9 weeks, and 18 months.)
- Exercise capacity - 6-minute walk distance (6MWD)(Baseline, 9 weeks, and 18 months.)
- Lower-Limb Functional Strength and Endurance - 1-minute Sit-to-Stand (STS)(Baseline, 9 weeks, and 18 months.)
- Trunk and Hamstring Flexibility - Fingertip-to-Floor Distance (FFD)(Baseline, 9 weeks, and 18 months.)
- Change in composite prognosis index (BODE Index)(Baseline, 9 weeks, and 18 months.)
- Change in airflow obstruction (post-bronchodilator FEV₁ percent predicted)(Baseline, 9 weeks, 18 months.)
- Change in Lower-Limb Muscle Strength (Isometric 1RM Tests)(Baseline and 9 weeks and 18 months)
- Change in Upper-Limb and Pectoral Muscle Strength (Isometric 1RM Tests)(Baseline and 9 weeks and 18 months.)
- Change in Muscular Endurance at 50% 1RM(Baseline and 9 weeks and 18 months.)
研究者
Benazzouz Redouene Sid Ahmed
Associate professor (maitre de conferences A) in Pneumology
Laghouat University