About this trial
This research aims to evaluate the effects of upper and lower limb exercises on muscle strength and pulmonary function in children diagnosed with CF. While aerobic training is a known component of CF management, resistance training focused on specific limb groups has gained attention for its additional benefits. Upper limb exercises may aid respiratory muscle endurance and thoracic mobility, enhancing pulmonary mechanics. In contrast, lower limb exercises (such as cycling or squats) are associated with improved oxygen consumption (VO₂ peak), enhanced mobility, and greater lower body strength.
This randomized clinical trial will be conducted using a non-probability convenience sampling technique. The study will take place at the pediatric cystic fibrosis centers of Gulab Devi Chest Hospital and The Children's Hospital, Lahore. The targeted population includes children aged 6 to 18 years who have been diagnosed with cystic fibrosis and referred to the physiotherapy department. The study duration will be ten months following the approval of the synopsis. Eligible participants will be children aged between 6 and 18 years, clinically diagnosed with cystic fibrosis, currently stable with no history of hospitalization or significant lung infection in the past month. They should be physically able to participate in exercise and capable of following instructions, with informed consent obtained from their parents or guardians. Children will be excluded if they suffer from other severe lung diseases, cardiovascular or orthopedic conditions that restrict exercise, recent surgery or hospitalization within the last month, or if they are unable to understand instructions. Those dependent on oxygen therapy or ventilator support at all times will also be excluded.
The primary outcome measures will include lung function assessed by spirometry (FVC, FEV1), sputum production recorded through a sputum diary, and aerobic capacity measured by the Incremental Shuttle Walk Test (ISWT). Muscle strength will be evaluated for both upper and lower limbs, using a handheld dynamometer for the upper limbs and the Sit-to-Stand Test for the lower limb
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children aged 6-18 years
Diagnosed with cystic fibrosis
Clinically stable
Able to perform exercise
Disqualifiers
Other severe pulmonary diseases
Cardiovascular or orthopedic limitations
Surgery or hospitalization within last 1 month
Inability to follow instructions
Trial design
Parallel
Treatments tested in this trial
Arm Cycle Ergometry
Other interventionParticipants will undergo upper limb resistance training using an arm cycle ergometer
Leg Cycle Ergometry
Other interventionParticipants will undergo lower limb resistance training using a leg cycle ergometer
Treatment groups
Trial outcomes
Primary outcomes
Incremental Shuttle Walk Test (ISWT)
The Incremental Shuttle Walk Test (ISWT) is a validated field-based measure of functional aerobic capacity in pediatric populations with chronic respiratory diseases, including cystic fibrosis. It provides a standardized assessment of exercise tolerance and cardiopulmonary endurance. Exercise training programs targeting limb musculature are expected to improve oxygen utilization and functional capacity, which can be objectively captured through changes in ISWT performance over time.
Sputum Production (Sputum Diary)
Daily sputum volume will be recorded using a structured sputum diary to assess airway clearance effectiveness. Exercise-induced enhancement of mucociliary clearance is expected to influence sputum expectoration patterns in children with cystic fibrosis. Monitoring sputum production provides a clinically relevant secondary outcome reflecting pulmonary secretion management and disease symptom burden.
Handheld Dynamometry
Upper limb muscle strength will be assessed using handheld dynamometry, which is a reliable and valid method for measuring isometric muscle force in pediatric clinical populations
Sit-to-Stand Test
Lower limb functional strength will be evaluated using the Sit-to-Stand Test, a simple and reproducible performance-based measure reflecting lower extremity strength and functional mobility.
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