Floor-Lift Series Pulmonary Rehabilitation for COPD: Short- and Long-Term Outcomes in a North African Setting

NCT ID: NCT07277855

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2027-06-30

Brief Summary

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.

Detailed Description

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.

• Primary outcome: program completion (≥22 daily FLS).
• Secondary outcomes:

• Clinical measures: mMRC, Borg CR10, CAT, and BODE index.
• Functional performance: Timed Up-and-Go (TUG), fingertip-to-floor distance (FFD), 6-minute walk distance (6MWD), and 1-minute sit-to-stand repetitions (STS).
• Predictors of non-completion (sociodemographic, medical, and psychosocial).
• Long-term adherence and maintenance of benefits. Safety data, exacerbations, musculoskeletal symptoms, and motivational barriers will be systematically recorded.

Analysis Plan Data will be analyzed using R software (v4.5.1). Categorical variables will be summarized as frequencies, continuous variables as medians (IQR). Between-group comparisons (completers vs non-completers) will use Mann-Whitney or Fisher's exact tests. Within-group changes will be analyzed using Wilcoxon signed-rank tests. Long-term adherence and maintenance will be evaluated with mixed-effects models. Significance will be set at p < 0.05.

Ethics and Dissemination The study protocol has been approved by the Ethics Committee of the Faculty of Medicine, University of Laghouat (Ref. 12/2024). Participation is voluntary, and data will be anonymized. Results will be disseminated through peer-reviewed publications, national and international respiratory conferences, and open-access repositories when applicable.

Conditions

COPD (Chronic Obstructive Pulmonary Disease); Muscle Weakness | Patient

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Floor-Lift Series (FLS) Program

All participants will undergo the Floor-Lift Series (FLS) pulmonary rehabilitation program - a 9-week, progressive, equipment-free intervention combining supervised and home-based sessions. The program focuses on improving lower-limb strength, balance, and mobility through repeated floor-to-stand transitions.

• Initial phase (Weeks 1-3): Mix of Supervised and home-based training, 7-15 repetitions/day, using wall or chair support.
• Intermediate phase (Weeks 4-6): 15-22 repetitions/day, primarily home-based.
• Consolidation phase (Weeks 7-9): 22 repetitions/day, independently at home. Participants receive safety instructions, telephone follow-ups for motivation, and are evaluated at baseline, week 9, and 18 months for adherence, clinical, and functional outcomes.

Group Type: EXPERIMENTAL

Floor-Lift Series (FLS) Pulmonary Rehabilitation Program

Intervention Type: BEHAVIORAL

A culturally adapted, low-cost, equipment-free behavioral rehabilitation program designed to enhance physical function in COPD patients with difficulty rising from the floor. The intervention involves progressive daily floor-to-stand exercises integrated into home practice and supervised sessions over nine weeks. Long-term follow-up evaluates sustained adherence and clinical benefits at 18 months.

Interventions

Floor-Lift Series (FLS) Pulmonary Rehabilitation Program

A culturally adapted, low-cost, equipment-free behavioral rehabilitation program designed to enhance physical function in COPD patients with difficulty rising from the floor. The intervention involves progressive daily floor-to-stand exercises integrated into home practice and supervised sessions over nine weeks. Long-term follow-up evaluates sustained adherence and clinical benefits at 18 months.

Intervention Type: BEHAVIORAL

Other Intervention Names

FLS Program

Eligibility Criteria

Inclusion Criteria

1. 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) .

2. Presence of muscle dysfunction limiting or complicating the ability to rise from the floor.

3. Clinically stable condition (no COPD exacerbation within the past 8 weeks).

4. Provided written informed consent.

Exclusion Criteria

1. Acute COPD exacerbation or hospitalization within the previous 8 weeks.

2. Recent myocardial infarction, unstable angina, or decompensated heart failure.

3. Severe neurological, orthopedic, or rheumatologic condition preventing safe floor exercise.

4. Cognitive impairment interfering with understanding or cooperation.

5. Refusal or withdrawal of informed consent.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Benazzouz Redouene Sid Ahmed

OTHER

Sponsor Role: lead

Responsible Party

Benazzouz Redouene Sid Ahmed

Associate professor (maitre de conferences A) in Pneumology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Redouene Sid Ahmed Benazzouz, DESM

Role: STUDY_DIRECTOR

Laghouat Public Hospital; Faculty of Medicine, Laghouat University

Hanane Fatemi, MD

Role: PRINCIPAL_INVESTIGATOR

Laghouat Public Hospital; Faculty of Medicine, Laghouat University

Locations

Laghouat University

Laghouat, Laghouat Province, Algeria

Countries

Algeria

Other Identifiers

LaghouatU

Identifier Type: -

Identifier Source: org_study_id