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COPD (Chronic Obstructive Pulmonary Disease)FLSNCT07277855

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

A study testing Floor-Lift Series (FLS) Pulmonary Rehabilitation Program in people with COPD (Chronic Obstructive Pulmonary Disease) and Muscle Weakness | Patient, run by Benazzouz Redouene Sid Ahmed at 1 site in Algeria.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Floor-Lift Series (FLS) Pulmonary Rehabilitation Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteAlgeria
Study dates
1 Dec 2024to 30 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Algeria1 site
  • Laghouat University

    Laghouat, Laghouat Province, 03000

Other trials in Algeria

About this study

Official title: 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

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.

Read more

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.

Read the 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.

Being tested
Floor-Lift Series (FLS) Pulmonary Rehabilitation Program
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
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Floor-Lift Series (FLS) Pulmonary Rehabilitation ProgramBehavioural

    Also called FLS 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.

Study groups in NCT07277855
Study groupRoleWhat they receive
Floor-Lift Series (FLS) ProgramExperimentalAll 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.
Receives: Behavioral: Floor-Lift Series (FLS) Pulmonary Rehabilitation Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (12)
  1. Change in dyspnea severity (modified Medical Research Council Dyspnea Scale, mMRC)

    Dyspnea will be measured using the modified Medical Research Council (mMRC) Dyspnea Scale, which ranges from 0 (no dyspnea) to 4 (very severe dyspnea). Higher scores indicate worse breathlessness and functional limitation. Change in mMRC score will be assessed from baseline to post-intervention (9 weeks) and at long-term follow-up (18 months). Negative changes (lower scores) will reflect clinical improvement, whereas positive changes (higher scores) will indicate worsening dyspnea.

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

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

    Perceived exertion during daily activities and during floor-lift exercises will be rated using the modified Borg Category-Ratio 10 (CR10) Scale, which ranges from 0 ("nothing at all") to 10 ("maximal"). Higher scores indicate greater perceived exertion and worse exercise tolerance. Change in Borg CR10 score will be calculated from baseline to each follow-up assessment (9 weeks, and 18 months). Decreases in score will indicate improved tolerance to effort, while increases will reflect worsening perceived exertion.

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

  3. Change in disease impact (COPD Assessment Test, CAT)

    COPD-related health status will be assessed using the COPD Assessment Test (CAT), an 8-item questionnaire with total scores ranging from 0 to 40. Higher CAT scores indicate worse symptom burden and poorer health status. Change in CAT total score will be evaluated from baseline to 9-week, and 18-month assessments. Negative changes (lower scores) will indicate an improvement in COPD-related health status, whereas positive changes (higher scores) will indicate deterioration.

    Measured: Baseline, 9 weeks, and 18 months.

  4. Change in mobility (Timed Up-and-Go test, TUG)

    Mobility and functional balance will be assessed using the Timed Up-and-Go (TUG) test, reported in seconds. Participants stand up from a chair, walk 3 meters, turn, walk back, and sit down. There is no fixed upper limit for TUG time. Higher TUG times indicate worse mobility and higher fall risk, whereas lower times indicate better functional mobility. Change in TUG time will be evaluated from baseline to post-intervention and long-term follow-up.

    Measured: Baseline, 9 weeks, and 18 months.

  5. Exercise capacity - 6-minute walk distance (6MWD)

    Exercise capacity will be evaluated using the 6-Minute Walk Test (6MWT), reported as 6-minute walk distance (6MWD) in meters. Participants are instructed to walk as far as possible along a flat corridor for 6 minutes. Higher 6MWD values indicate better exercise capacity, whereas lower values indicate reduced functional capacity. Change in 6MWD will be assessed from baseline to post-intervention and long-term follow-up.

    Measured: Baseline, 9 weeks, and 18 months.

  6. Lower-Limb Functional Strength and Endurance - 1-minute Sit-to-Stand (STS)

    Lower-limb functional strength and functional capacity will be assessed using the 1-Minute Sit-to-Stand (1-min STS) test, reported as the number of complete sit-to-stand repetitions performed in 60 seconds from a standard chair without using the arms. Higher repetition counts indicate better lower-limb strength and functional capacity, whereas lower counts indicate poorer performance. Change in 1-min STS repetitions will be evaluated from baseline to post-intervention and long-term follow-up.

    Measured: Baseline, 9 weeks, and 18 months.

  7. Trunk and Hamstring Flexibility - Fingertip-to-Floor Distance (FFD)

    Flexibility of the posterior chain will be assessed using the Fingertip-to-Floor Distance (FFD), measured in centimeters during a standardized forward bend with knees extended. An FFD of 0 cm indicates that the fingertips reach the floor, reflecting better flexibility, whereas higher positive values indicate reduced flexibility (greater distance between fingertips and floor). Change in FFD will be evaluated from baseline to post-intervention and long-term follow-up; decreases in FFD indicate improved flexibility, while increases indicate worsening flexibility.

    Measured: Baseline, 9 weeks, and 18 months.

  8. Change in composite prognosis index (BODE Index)

    Overall COPD prognosis will be assessed using the BODE Index (Body mass index, Airflow Obstruction, Dyspnea, Exercise capacity). The BODE Index is a composite score ranging from 0 to 10, calculated from four components: body mass index (BMI, kg/m²), post-bronchodilator FEV₁ percent predicted, dyspnea severity measured by the modified Medical Research Council (mMRC) Dyspnea Scale (0-4), and exercise capacity measured by the 6-minute walk distance (6MWD, meters). Each component is categorized and assigned points according to the original BODE model; component points are then summed to obtain the total BODE score. Higher BODE scores indicate a worse prognosis (higher risk of mortality and hospitalizations), whereas lower scores indicate a more favorable prognosis. The primary reported value for this Outcome Measure will be the total BODE Index score and its change from baseline at 9 weeks, and 18 months.

    Measured: Baseline, 9 weeks, and 18 months.

  9. Change in airflow obstruction (post-bronchodilator FEV₁ percent predicted)

    Airflow obstruction will be assessed by post-bronchodilator spirometry, reporting forced expiratory volume in 1 second (FEV₁) as percent of the predicted value for age, sex, height, and ethnicity. Lower FEV₁ percent predicted indicates more severe airflow limitation. Change in FEV₁ percent predicted will be evaluated from baseline to post-intervention (9 weeks) and at 18 months follow-up assessments; increases in FEV₁ percent predicted will indicate improvement, whereas decreases will indicate worsening obstruction.

    Measured: Baseline, 9 weeks, 18 months.

  10. Change in Lower-Limb Muscle Strength (Isometric 1RM Tests)

    Isometric maximal voluntary contraction (1RM, in kilograms of force) for:

    • Knee extension
    • Knee flexion The outcome is the change in 1RM for each movement from baseline to end of program (and follow-up if repeated). Higher values indicate greater muscle strength.

    Measured: Baseline and 9 weeks and 18 months

  11. Change in Upper-Limb and Pectoral Muscle Strength (Isometric 1RM Tests)

    Isometric maximal voluntary contraction (1RM, kgf) for:

    • Shoulder flexion
    • Pectoral press Again, outcome is change in 1RM from baseline to end of program. Higher values indicate greater strength.

    Measured: Baseline and 9 weeks and 18 months.

  12. Change in Muscular Endurance at 50% 1RM

    Muscular endurance tests at 50% of 1RM, recorded as number of repetitions or time maintained (depending on your exact protocol) for:

    • Knee extension
    • Knee flexion
    • Shoulder flexion
    • Pectoral press Outcome: change in endurance measure from baseline to end of program. Higher values = better endurance.

    Measured: Baseline and 9 weeks and 18 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2025
  2. Study start1 Dec 2024
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07277855
Sponsor's protocol ID
LaghouatU
Acronym
FLS
Status last verified
Nov 2025
First submitted
19 Nov 2025
Last updated
11 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data underlying the main publication will be shared, including baseline characteristics, intervention adherence, and all primary and secondary outcome measures (dyspnea, perceived exertion, exercise capacity tests, flexibility measures, BODE index, exacerbations, and hospitalizations). No directly identifying information will be shared.

Publications

  • Benazzouz RSA, Benyagoub M, Fatmi HM, Zenikheri A, Lagraa L, Benazzouz MS, Hadjersi F, Litim A, Ould Setti M. Culturally Adapted Floor-to-Stand Exercises for COPD: A Quasi-Experimental Study. Thorac Res Pract. 2026 Sep 25. doi: 10.4274/ThoracResPract.2026.2026-2-11. Online ahead of print.

    PubMed 42786795

Questions about this trial

What is this clinical trial studying?

A study testing Floor-Lift Series (FLS) Pulmonary Rehabilitation Program in people with COPD (Chronic Obstructive Pulmonary Disease) and Muscle Weakness | Patient, run by Benazzouz Redouene Sid Ahmed at 1 site in Algeria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Algeria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adherence rate to the Floor-Lift Series (FLS) program (time frame: At 9 weeks (end of intervention), and 18 months after program initiation.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07277855, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.

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