Clinical trial NCT04803643: Upper Extremity Exercise Capacity, Muscle Oxygenation, Balance in Patients With Cystic Fibrosis
Official title: Investigation of Upper Extremity Exercise Capacity, Muscle Oxygenation, Balance and Physical Activity Level in Patients With Cystic Fibrosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Keywords: cystic fibrosis
upper extremity exercise capacity
muscle oxygenation
balance
physical activity
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2021-03-18
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: At least 30 patients with cystic fibroisis will be included in patients group and 30 healthy individuals will be included in control group

Brief summary: The primary aim of the study is to evaluate upper extremity exercise capacity, muscle oxygenation, balance and physical activity level in patients with cystic fibrosis.. The secondary aim of the study is assessment of functional exercise capacity, respiratory function, peripheral and respiratory muscle strength, respiratory muscle endurance, quality of life in patients with cystic fibrosis and compare them with healthy controls.

Detailed description: Cystic fibrosis (CF) is an autosomal recessive genetic disease. Although it is a monogenetic type of disease, its phenotype varies widely. CF is characterized by progressive lung disease, malabsorption of fat and protein, fatty stools, pancreatic insufficiency resulting in gastrointestinal malabsorption, intestinal abnormalities resulting in malnutrition, growth retardation, sinusitis, and diabetes. The most important problems seen in patients are excessive secretion, decreased exercise capacity, dyspnea and muscle strength loss. Exercise capacity, respiratory functions, respiratory and peripheral muscle strength, respiratory muscle endurance, balance, physical activity, quality of life are poor in cystic fibrosis patients.There are insufficient studies on this subject in the literature. The number of studies using objective method is few. Cystic fibrosis patients have upper extremity muscle weakness. There is no study on the evaluation of upper extremity exercise capacity in these patients in the literature. Even if patients with CF have normal pulmonary function test results, there are studies showing that exercise intolerance has developed. These reasons have revealed the need to investigate oxygen metabolism at the cellular level.There are only two studies in the literature evaluating muscle oxygenation in patients with cystic fibrosis. There is no study evaluating with a "Moxy" monitor.The primary aim of the study is to evaluate upper extremity exercise capacity, muscle oxygenation, balance and physical activity level in patients with cystic fibrosis.. The secondary aim of the study is assessment of functional exercise capacity, respiratory function, peripheral and respiratory muscle strength, respiratory muscle endurance, quality of life in patients with cystic fibrosis and compare them with healthy controls.

The study was planned cross-sectional. At least 30 cystic fibrosis patients and 30 age- and sex-matched healthy controls will be included in the study. Individuals' exercise capacity, respiratory functions, physical activity levels, balance assessments, peripheral and respiratory muscle strength, respiratory muscle endurance, muscle oxygenation and quality of life will be evaluated. Upper extremity exercise capacity will be assessed using six minute pegboard ring test, functional exercise capacity using six minute walk test, muscle oxygenation using "Moxy" monitor, balance using "Biodex Balance System®" and Y balance test, physical activity using multi-sensor activity monitor, pulmonary function using spirometry, respiratory muscle strength using mouth pressure device, peripheral muscle strength using hand held dynamometer, respiratory muscle endurance using incremental threshold loading test, life quality using "The Revised Cystic Fibrosis Questionnaire (CFQ-R)" (Turkish version). The assessments will be completed in two days.

Eligibility criteria: Inclusion Criteria:

Patients;

* 6-18 years old
* Diagnosed with cystic fibrosis according to the American Cystic Fibrosis Association consensus report criteria
* Those who have not participated in the exercise training program planned in the last 3 months

Healthy controls;

* 6-18 years old

Exclusion Criteria:

Patients;

* A history of lung or liver transplant
* Diagnosed vision, hearing, vestibular, or neurological problems that can affect balance
* History of hospitalization previously (1 month)
* History of coronavirus disease (COVID-19)
* History of smoking
* Diagnosed orthopedic problems affecting mobility or a history of musculoskeletal surgery
* Acute pulmonary exacerbation
* Diagnosed with allergic
* Bronchopulmonary aspergillosis
* Systemic corticosteroids use
* Pulmonary hypertension and cardiovascular instability

Healthy controls;

* Trouble understanding and following the exercise test instruction
* A history of smoking

Primary outcomes:
measure: Upper extremity exercise capacity
timeFrame: First Day
Secondary outcomes:
measure: Functional exercise capacity
timeFrame: First Day
measure: Muscle Oxygenation
timeFrame: First Day
measure: Balance
timeFrame: Second Day
measure: Physical activity (Total energy expenditure)
timeFrame: Second Day
measure: Physical activity (Active energy expenditure (joule / day))
timeFrame: Second Day
measure: Physical activity (Physical activity time (min / day))
timeFrame: Second Day
measure: Physical activity (Average metabolic equivalent (MET / day))
timeFrame: Second Day
measure: Physical activity (Number of steps (steps / day))
timeFrame: Second Day
measure: Physical activity (Time spent lying down (min / day) days))
timeFrame: Second Day
measure: Physical activity (Sleep time (min / day))
timeFrame: Second Day
measure: Pulmonary function (Forced vital capacity (FVC))
timeFrame: First Day
measure: Pulmonary function (Forced expiratory volume in the first second (FEV1))
timeFrame: First Day
measure: Pulmonary function (FEV1 / FVC)
timeFrame: First Day
measure: Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))
timeFrame: First Day
measure: Pulmonary function (Peak flow rate (PEF))
timeFrame: First Day
measure: Respiratory muscle strength
timeFrame: First Day
measure: Peripheral muscle strength
timeFrame: Second Day
measure: Respiratory muscle endurance
timeFrame: Second Day
measure: Life quality
timeFrame: Second Day
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University Faculty of Health Science Department of Physiotherapy and Rehabilitation
city: Ankara
country: Turkey
facility: Gazi University Faculty of Health Sciences Department of Physical Therapy and Rehabilitation
state: Çankaya
Study officials:
affiliation: Gazi University
name: Betül YOLERİ, Pt
role: STUDY_CHAIR
affiliation: Gazi University
name: Meral BOŞNAK GÜÇLÜ, Prof.Dr.
role: STUDY_DIRECTOR
affiliation: Gazi University
name: Ayşe TANA ARSLAN, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University
name: Tuğba ŞİŞMANLAR EYÜBOĞLU, Asc. Prof.Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sharma R, Florea VG, Bolger AP, Doehner W, Florea ND, Coats AJ, Hodson ME, Anker SD, Henein MY. Wasting as an independent predictor of mortality in patients with cystic fibrosis. Thorax. 2001 Oct;56(10):746-50. doi: 10.1136/thorax.56.10.746.
citation: Arikan H, Yatar I, Calik-Kutukcu E, Aribas Z, Saglam M, Vardar-Yagli N, Savci S, Inal-Ince D, Ozcelik U, Kiper N. A comparison of respiratory and peripheral muscle strength, functional exercise capacity, activities of daily living and physical fitness in patients with cystic fibrosis and healthy subjects. Res Dev Disabil. 2015 Oct-Nov;45-46:147-56. doi: 10.1016/j.ridd.2015.07.020. Epub 2015 Aug 1.
citation: Erickson ML, Seigler N, McKie KT, McCully KK, Harris RA. Skeletal muscle oxidative capacity in patients with cystic fibrosis. Exp Physiol. 2015 Apr 20;100(5):545-52. doi: 10.1113/EP085037.
citation: Schneiderman JE, Wilkes DL, Atenafu EG, Nguyen T, Wells GD, Alarie N, Tullis E, Lands LC, Coates AL, Corey M, Ratjen F. Longitudinal relationship between physical activity and lung health in patients with cystic fibrosis. Eur Respir J. 2014 Mar;43(3):817-23. doi: 10.1183/09031936.00055513. Epub 2013 Oct 31.
citation: Santana NN, Chaves CRMM, Goncalves CP, Gomes Junior SCDS. FACTORS ASSOCIATED TO QUALITY OF LIFE IN CHILDREN AND ADOLESCENTS WITH CYSTIC FIBROSIS. Rev Paul Pediatr. 2020 Jun 19;38:e2018397. doi: 10.1590/1984-0462/2020/38/2018397. eCollection 2020.