Clinical trial NCT05655637: Effects of Breathing Exercises Combined With Endurance and Strength Training in Patients With Cystic Fibrosis.
Official title: Effects of Breathing Exercises Combined With Endurance and Strength Training on Dyspnea, Exercise Capacity and Quality of Life of Patients With Cystic Fibrosis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis Patients
Keywords: Cystic Fibrosis
Active cycle Breathing technique
6 minute walk test
Borg scale
Quality of life
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-12-19
Enrollment: 28
Sex: ALL
Minimum age (years): 14
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Cystic fibrosis (CF) is a multi-system inherited disease. It's a common autosomal recessive illness. It mostly affects the lungs, liver, and pancreatic exocrine glands, as well as the intestines. The production of viscous mucus and an environment prone to chronic airway blockage. This allows harmful microorganisms to infect the lungs. The role of Exercise as a prognostic indicator or therapeutic aid is important in CF research around the world. The objective of this study is to find out the Effects of Breathing Exercises Combined with Endurance and Strength Training on Dyspnea and Quality of Life of patients with Cystic Fibrosis. It will be Quasi Experimental study. Treatment will be given to all participants 3 sessions in a week for 4 weeks. Pre and Post treat-meant evaluation will be checked by CFQ-R+14. All patients will be treated with exercise program of Active cycle breathing techniques(ACBT), Pursed lip breathing, Endurance Exercise 20 to 30 min ( walking, cycling) and strength training with Thera-Bands (Bilateral arm raising, Bilateral knee extension). Exercise capacity will be measured with 6MWT. Dyspnea and fatigue will be measured with Borg scale.


Eligibility criteria: Inclusion Criteria:

* Age 14-50 years
* Male and female both will be included
* clinically stable
* Shortness of breath on effort

Exclusion Criteria:

* smoking history \>10 years
* clinical diagnosis of asthma
* Physical and psychological disability preventing participation
* medical condition which could place individuals at risk during exercise training

Primary outcomes:
measure: 6-min walk test (6MWT)
timeFrame: 4 Weeks
measure: CFQ-R14+
timeFrame: 4 Weeks
measure: Borg Scale
timeFrame: 4 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Bahria International Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Hafiza Muriam Ghani, MSCPPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mckoy NA, Wilson LM, Saldanha IJ, Odelola OA, Robinson KA. Active cycle of breathing technique for cystic fibrosis. Cochrane Database Syst Rev. 2016 Jul 5;7(7):CD007862. doi: 10.1002/14651858.CD007862.pub4.
citation: Kapnadak SG, Dimango E, Hadjiliadis D, Hempstead SE, Tallarico E, Pilewski JM, Faro A, Albright J, Benden C, Blair S, Dellon EP, Gochenour D, Michelson P, Moshiree B, Neuringer I, Riedy C, Schindler T, Singer LG, Young D, Vignola L, Zukosky J, Simon RH. Cystic Fibrosis Foundation consensus guidelines for the care of individuals with advanced cystic fibrosis lung disease. J Cyst Fibros. 2020 May;19(3):344-354. doi: 10.1016/j.jcf.2020.02.015. Epub 2020 Feb 27.
citation: Rand S, Prasad SA. Exercise as part of a cystic fibrosis therapeutic routine. Expert Rev Respir Med. 2012 Jun;6(3):341-51; quiz 352. doi: 10.1586/ers.12.19.
citation: Pastre J, Prevotat A, Tardif C, Langlois C, Duhamel A, Wallaert B. Determinants of exercise capacity in cystic fibrosis patients with mild-to-moderate lung disease. BMC Pulm Med. 2014 Apr 30;14:74. doi: 10.1186/1471-2466-14-74.
citation: Robinson KA, McKoy N, Saldanha I, Odelola OA. Active cycle of breathing technique for cystic fibrosis. Cochrane Database Syst Rev. 2010 Nov 10;(11):CD007862. doi: 10.1002/14651858.CD007862.pub2.
citation: Ziegler B, Rovedder PM, Oliveira CL, de Abreu e Silva F, de Tarso Roth Dalcin P. Repeatability of the 6-minute walk test in adolescents and adults with cystic fibrosis. Respir Care. 2010 Aug;55(8):1020-5.
citation: Quon BS, Wilkie SS, Ramsook AH, Schaeffer MR, Puyat JH, Wilcox PG, Guenette JA. Qualitative dimensions of exertional dyspnea in adults with cystic fibrosis. J Appl Physiol (1985). 2016 Aug 1;121(2):449-56. doi: 10.1152/japplphysiol.00391.2016. Epub 2016 Jun 16.