Exercises' Effect on Muscle Strength, Aerobic Capacity and Respiratory Functions in Cystic Fibrosis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-18
SponsorRiphah International University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Arm Cycle Ergometry

    Other intervention

    Participants will undergo upper limb resistance training using an arm cycle ergometer

  • Leg Cycle Ergometry

    Other intervention

    Participants will undergo lower limb resistance training using a leg cycle ergometer

Treatment groups

22 Participants
are divided into 2 treatment groups
Group A: Upper Limb Exercise TrainingExperimental treatment 1 intervention
Group B: Lower Limb Exercise TrainingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline; 4th Week; 8th Week
2

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.

Time frame
Baseline; 4th Week; 8th Week
3

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

Time frame
Baseline; 4th Week; 8th Week
4

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.

Time frame
Baseline; 4th Week; 8th Week

Secondary outcomes

Other outcomes

Sponsors and contacts

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