Exercises' Effect on Muscle Strength, Aerobic Capacity and Respiratory Functions in Cystic Fibrosis
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Arm Cycle Ergometry, Leg Cycle Ergometry.
- Кому может быть актуально
- Состояния в реестре: Cystic Fibrosis (CF). Базовые параметры: 6 лет — 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Пакистан
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
Effects of Upper and Lower Limb Exercises on Muscle Strength, Aerobic Capacity and Respiratory Functions in Children With Cystic Fibrosis
Обзор
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
Подробное описание
Cystic fibrosis is a chronic, inherited disorder caused by mutations in the CFTR gene, which disrupt the normal function of epithelial cells involved in fluid transport. This results in the accumulation of thick and sticky mucus in multiple organs, primarily affecting the lungs and digestive system. The disease leads to chronic respiratory infections, obstructive lung disease, pancreatic insufficiency, malabsorption, and other systemic complications. Cystic fibrosis affects approximately 70,000 people globally, with the highest prevalence among individuals of Northern European descent, where approximately one in every 3,000 births is affected, and about one in 25 people are carriers of the faulty gene. Early diagnosis and advancements in treatment have significantly improved the life expectancy of individuals with this condition, with many now surviving well into adulthood.
Children with cystic fibrosis typically present with a range of symptoms such as a persistent cough, recurrent chest infections, wheezing, poor growth despite adequate nutrition, steatorrhea, and clubbing of the fingers. The thick mucus in the airways leads to repeated bacterial infections and airway obstruction, which over time causes irreversible lung damage. Alongside pulmonary issues, these children also face gastrointestinal problems due to enzyme deficiency, liver complications, and difficulties in absorbing vital nutrients. These systemic effects contribute to a cycle of malnutrition, reduced energy, and compromised immune response. Physical inactivity, systemic inflammation, and chronic illness further contribute to muscle weakness, especially in the limbs, reducing a child's ability to perform routine activities.
Treatment for cystic fibrosis is multidisciplinary and includes both medical and therapeutic interventions. Medical treatment primarily focuses on managing infections, improving mucus clearance, and enhancing nutritional status. Common therapies include airway clearance techniques, inhaled bronchodilators, mucolytics like hypertonic saline and dornase alfa, antibiotics (oral and intravenous), pancreatic enzyme replacement therapy, and CFTR modulators such as ivacaftor, lumacaftor/ivacaftor, or the triple combination therapy elexacaftor/tezacaftor/ivacaftor. These medications have transformed the management of cystic fibrosis by targeting the basic genetic defect and improving lung function, quality of life, and survival. However, not all patients are eligible for modulators, and supportive care remains essential for all individuals with cystic fibrosis.
Physical therapy plays a critical role in the comprehensive management of cystic fibrosis. Exercise is now considered a standard component of cystic fibrosis care, as it assists in mucus clearance, improves ventilatory capacity, enhances cardiovascular fitness, and supports musculoskeletal health. Regular physical activity, particularly aerobic and resistance exercises, has shown positive effects on lung function, endurance, and quality of life in children and adolescents with cystic fibrosis. Due to muscle wasting and inactivity, children often exhibit generalized muscle weakness, especially in the limbs. This loss of strength contributes to increased fatigue, reduced mobility, and decreased participation in daily activities. In low- and middle-income countries like Pakistan, limited access to advanced CF care-including genetic testing, airway clearance devices, and multidisciplinary support-places a greater burden on conservative and cost-effective interventions such as physiotherapy. While pharmacologic management remains vital, physiotherapy-based interventions, especially structured exercise programs, offer a non-invasive and sustainable means to improve clinical outcomes in children. However, there is limited localized research on the effectiveness of such interventions within the Pakistani healthcare context, especially in the pediatric population.
Targeted upper and lower limb exercises have recently gained attention in cystic fibrosis rehabilitation programs. Upper limb exercises such as arm cycling, resistance band work, and weight training can improve thoracic mobility, respiratory muscle endurance, and shoulder girdle strength. These improvements may indirectly support respiratory mechanics and facilitate better airway clearance. Lower limb exercises, including squats, cycling, and walking, contribute to improved lower body strength, walking capacity, and overall aerobic endurance. Studies suggest that both types of exercises can have unique benefits in maintaining physical function and slowing disease progression in pediatric patients. Resistance training involving the limbs also helps in increasing lean muscle mass, improving posture, and reducing fatigue during physical tasks.
Despite the growing use of exercise in cystic fibrosis care, there is limited evidence comparing the effectiveness of upper versus lower limb training in children with cystic fibrosis. It remains unclear whether one form of exercise has superior benefits in enhancing muscle strength and pulmonary function or if a combined approach is most effective. This lack of clarity highlights the need for focused research to guide clinical physiotherapy protocols. Evaluating the specific impact of each limb-focused intervention can help physiotherapists design more personalized and effective treatment plans.
The present research aims to assess the effects of upper and lower limb exercise programs on muscle strength and pulmonary function in children with cystic fibrosis. By identifying which approach yields better outcomes in terms of respiratory capacity and physical performance, this study can provide valuable evidence for setting more targeted rehabilitation protocols. Such findings have the potential to enhance the standard of care, reduce the physical decline associated with the disease, and promote long-term health and independence in affected children.
The present study aims to investigate the comparative effects of upper and lower limb exercise regimens on muscle strength and respiratory functions in children with cystic fibrosis. Key respiratory indicators such as Forced Expiratory Volume in 1 second (FEV₁) and Forced Vital Capacity (FVC), alongside validated strength assessments, will be used to evaluate outcomes. This research is intended to provide evidence-based recommendations for integrating tailored exercise programs into early physiotherapeutic management for CF patients, particularly within the pediatric healthcare setting in Pakistan
Вмешательства
- Другое Arm Cycle Ergometry
Participants will undergo upper limb resistance training using an arm cycle ergometer - Другое Leg Cycle Ergometry
Participants will undergo lower limb resistance training using a leg cycle ergometer
Первичные конечные точки
- Incremental Shuttle Walk Test (ISWT) [Срок оценки: Baseline; 4th Week; 8th Week]
- Sputum Production (Sputum Diary) [Срок оценки: Baseline; 4th Week; 8th Week]
- Handheld Dynamometry [Срок оценки: Baseline; 4th Week; 8th Week]
- Sit-to-Stand Test [Срок оценки: Baseline; 4th Week; 8th Week]
- Pulmonary Function Test [Срок оценки: Baseline; 4th Week; 8th Week]
Критерии участия
Критерии включения
- Children aged 6-18 years
- Diagnosed with cystic fibrosis
- Clinically stable
- Able to perform exercise
- Parental/guardian consent provided
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
Пакистан · 1 центр
- Gulab Devi Chest Hospital — Lahore
Публикации
- 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- PMID 37898788
- 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
- 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
- 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
- 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
- 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
- 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 FI PMID 40966068
Идентификаторы
NCT: NCT07508904 · Mahnoor Shakir REC/25/0306