Upper Extremity Exercise Capacity, Muscle Oxygenation, Balance in Patients With Cystic Fibrosis

NCT04803643 | Completed

• 1 other identifier: Gazi University 22
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Cystic Fibrosis

Keywords

cystic fibrosis; upper extremity exercise capacity; muscle oxygenation; balance; physical activity

Outcome Measures

Primary Outcomes (1)

• Upper extremity exercise capacity

  Upper extremity exercise capacity will be evaluated with the 6-Minute Pegboard and Ring Test (Total number of rings). There are a total of 20 rings on the 4 iron bars on the board to be used. Patients will be asked to wear the rings with both hands first from top to bottom and then from bottom to top. At the end of 6 minutes, the total attached ring will be recorded in terms of pieces.

  First Day

Secondary Outcomes (19)

• Functional exercise capacity

  First Day

• Muscle Oxygenation

  First Day

• Balance

  Second Day

• Physical activity (Total energy expenditure)

  Second Day

• Physical activity (Active energy expenditure (joule / day))

  Second Day

Study Arms (2)

Patients

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).

Healthy controls

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).

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• Patients;
• 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;
• years old

You may not qualify if:

• 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

Sponsors & Collaborators

• Gazi University: lead

Study Sites (2)

Gazi University Faculty of Health Science Department of Physiotherapy and Rehabilitation

Ankara, 06500, Turkey (Türkiye)

Location

Gazi University Faculty of Health Sciences Department of Physical Therapy and Rehabilitation

Ankara, Çankaya, 06580, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 11562511 BACKGROUND

• 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.

  PMID: 26241869 BACKGROUND

• 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.

  PMID: 25758606 BACKGROUND

• 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.

  PMID: 24176992 BACKGROUND

• 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.

  PMID: 32578674 BACKGROUND

MeSH Terms

Conditions

Cystic Fibrosis; Motor Activity

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; Behavior

Study Officials

• Betül YOLERİ, Pt

  Gazi University

  STUDY CHAIR

• Meral BOŞNAK GÜÇLÜ, Prof.Dr.

  Gazi University

  STUDY DIRECTOR

• Ayşe TANA ARSLAN, Prof.Dr.

  Gazi University

  PRINCIPAL INVESTIGATOR

• Tuğba ŞİŞMANLAR EYÜBOĞLU, Asc. Prof.Dr

  Gazi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 18, 2021
• Study Start: March 16, 2021
• Primary Completion: February 28, 2022
• Study Completion: March 15, 2022
• Last Updated: April 6, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)