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

NCT07508904 | Recruiting

• 1 other identifier: Mahnoor Shakir REC/25/0306
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cystic Fibrosis (CF)

Keywords

Cystic Fibrosis; Muscle Strength; Respiratory Function; Upper and Lower Limb Exercises; Pediatric Rehabilitation

Outcome Measures

Primary Outcomes (5)

• 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.

  Baseline; 4th Week; 8th Week

• 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.

  Baseline; 4th Week; 8th Week

• 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

  Baseline; 4th Week; 8th Week

• 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.

  Baseline; 4th Week; 8th Week

• Pulmonary Function Test

  Forced Expiratory Volume in one second (FEV₁) and Forced Vital Capacity (FVC) are widely accepted clinical indicators of pulmonary function and disease progression in children with cystic fibrosis. These spirometric parameters provide objective measurement of airway obstruction and ventilatory capacity and are recommended outcome measures in exercise-based pulmonary rehabilitation trials. Improvement in FEV₁ and FVC reflects enhanced airway clearance, reduced airflow limitation, and improved respiratory muscle performance following therapeutic exercise interventions.

  Baseline; 4th Week; 8th Week

Study Arms (2)

Upper Limb Exercise Training

EXPERIMENTAL

Participants will undergo upper limb resistance training using an arm cycle ergometer consisting of: Warm-up: 5-10 minutes at 30-40% peak work rate Training: 2-3 sessions/week Intensity: 50-85% peak resistance Sets: 1-3 sets of 6-15 revolutions with 1-2 minute rest Cool-down: 5-10 minutes low resistance

Other: Arm Cycle Ergometry

Lower Limb Exercise Training

EXPERIMENTAL

Participants will undergo lower limb resistance training using a leg cycle ergometer consisting of: Warm-up: 5-10 minutes at 30-40% peak work rate Training: 2-3 sessions/week Intensity: 50-85% peak resistance Sets: 1-3 sets of 6-15 revolutions with 1-2 minute rest Cool-down: 5-10 minutes low resistance

Other: Leg Cycle Ergometry

Interventions

Arm Cycle Ergometry OTHER

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

Upper Limb Exercise Training

Leg Cycle Ergometry OTHER

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

Lower Limb Exercise Training

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children aged 6-18 years
• Diagnosed with cystic fibrosis
• Clinically stable
• Able to perform exercise
• Parental/guardian consent provided

You may not qualify if:

• Other severe pulmonary diseases
• Cardiovascular or orthopedic limitations
• Surgery or hospitalization within last 1 month
• Inability to follow instructions
• Oxygen-dependent or ventilator-dependent patients

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Gulab Devi Chest Hospital

Lahore, 547000, Pakistan

RECRUITING

Related Publications (7)

• Hamedi N, Kajbafvala M, ShahAli S, Pourahmadi M, Eshghi A, Estahbanati MM. The effects of aerobic exercises compared to conventional chest physiotherapy on pulmonary function, functional capacity, sputum culture, and quality of life in children and adolescents with cystic fibrosis: a study protocol for randomized controlled trial study. Trials. 2023 Oct 28;24(1):695. doi: 10.1186/s13063-023-07719-w.

  PMID: 37898788 BACKGROUND

• Elbasan B, Tunali N, Duzgun I, Ozcelik U. Effects of chest physiotherapy and aerobic exercise training on physical fitness in young children with cystic fibrosis. Ital J Pediatr. 2012 Jan 10;38:2. doi: 10.1186/1824-7288-38-2.

  PMID: 22233967 BACKGROUND

• Abdelbasset WK, Soliman GS, Elshehawy AA, Alrawaili SM. Exercise capacity and muscle fatiguability alterations following a progressive maximal exercise of lower extremities in children with cystic fibrosis. Afr Health Sci. 2018 Dec;18(4):1236-1242. doi: 10.4314/ahs.v18i4.45.

  PMID: 30766590 BACKGROUND

• Cai W, Li M, Xu Y, Li M, Wang J, Zuo Y, Cao J. The effect of respiratory muscle training on children and adolescents with cystic fibrosis: a systematic review and meta-analysis. BMC Pediatr. 2024 Apr 15;24(1):252. doi: 10.1186/s12887-024-04726-x.

  PMID: 38622583 BACKGROUND

• Pinto ACPN, Piva SR, Rocha A, Gomes-Neto M, Atallah AN, Saconato H, Trevisani VF. Digital technology for delivering and monitoring exercise programs for people with cystic fibrosis. Cochrane Database Syst Rev. 2023 Jun 9;6(6):CD014605. doi: 10.1002/14651858.CD014605.pub2.

  PMID: 37294546 BACKGROUND

• Paula IR, Ronchi CF, Oliveira Azevedo VMG. Telerehabilitation in cystic fibrosis: a randomized clinical trial protocol for increasing exercise loads and difficulty levels (TeleCist). Trials. 2025 Oct 27;26(1):439. doi: 10.1186/s13063-025-08866-y.

  PMID: 41146210 BACKGROUND

• Pantoja-Arevalo L, Yvert T, Iturriaga T, Sanz-Santiago V, Barcelo O, Quesada-Gonzalez C, Morales-Tirado A, Santiago-Dorrego C, Lopez-Neyra A, Ruiz de Valbuena M, De Manuel Gomez C, Rubio Alonso M, De Vidania S, Ramirez-Castillejo C, Gonzalez-Gross M, Perez-Ruiz M. Strength-Oriented Virtual Exercise Training Intervention in Children and Adolescents with Cystic Fibrosis Under CFTR Modulators (the FIQMODE Study): Study Protocol for a Randomized Controlled Trial. Curr Protoc. 2025 Sep;5(9):e70202. doi: 10.1002/cpz1.70202.

  PMID: 40966068 BACKGROUND

MeSH Terms

Conditions

Cystic Fibrosis; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Respiration Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Danish Hassan, PhD

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Danish Hassan, PhD

CONTACT

+92 345 7946009; danish.hassan009@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: April 2, 2026
• Study Start: December 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)