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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Number and nature of musculoskeletal, cardiovascular, or respiratory adverse events reported during or after FLS training.