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

NCT07277855 | Active Not Recruiting

• 1 other identifier: LaghouatU
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Chronic Obstructive Pulmonary Disease; Pulmonary Rehabilitation; Floor-Lift Series; Home-Based Exercise; Equipment-Free Training; Exercise Capacity; Program Adherence; North Africa; Algeria; Culturally Adapted Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Adherence rate to the Floor-Lift Series (FLS) program

  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.

  At 9 weeks (end of intervention), and 18 months after program initiation.

Secondary Outcomes (12)

• Change in dyspnea severity (modified Medical Research Council Dyspnea Scale, mMRC)

  Baseline, 3 weeks, 6 weeks, 9 weeks, and 18 months.

• Change in perceived exertion (modified Borg Category-Ratio 10 Scale, CR10)

  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.

Other Outcomes (1)

• Incidence of adverse events

  Throughout the 9-week program and during the 18 -month follow-up period.

Study Arms (1)

Floor-Lift Series (FLS) Program

EXPERIMENTAL

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.

Behavioral: Floor-Lift Series (FLS) Pulmonary Rehabilitation Program

Interventions

Floor-Lift Series (FLS) Pulmonary Rehabilitation Program 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.

Also known as: FLS Program

Floor-Lift Series (FLS) Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Benazzouz Redouene Sid Ahmed: lead

Study Sites (1)

Laghouat University

Laghouat, Laghouat Province, 03000, Algeria

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Redouene Sid Ahmed Benazzouz, DESM

  Laghouat Public Hospital; Faculty of Medicine, Laghouat University

  STUDY DIRECTOR

• Hanane Fatemi, MD

  Laghouat Public Hospital; Faculty of Medicine, Laghouat University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor (maitre de conferences A) in Pneumology

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 11, 2025
• Study Start: December 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: December 11, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: IPD and supporting documents will be available beginning 6 to 12 months after publication of the main trial results and for at least 5 years thereafter, or longer if scientifically justified and if resources allow.
• Access Criteria: De-identified IPD will be made available to qualified researchers affiliated with academic or public institutions, for non-commercial research questions that are consistent with the objectives of the trial. Investigators must submit a written request with a brief proposal and analysis plan. Access will be granted after approval by the principal investigator and, if required, the local ethics committee, and following signature of a data use agreement specifying data security, prohibition of re-identification, and obligation to acknowledge the original study.

Locations

AL (1)