Effects of Breathing Exercises Combined With Endurance and Strength Training in Patients With Cystic Fibrosis.

NCT05655637 | Completed

• 1 other identifier: REC/RCR&AHS/22/0342
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis Patients

Keywords

Cystic Fibrosis; Active cycle Breathing technique; 6 minute walk test; Borg scale; Quality of life

Outcome Measures

Primary Outcomes (3)

• 6-min walk test (6MWT)

  The 6-min walk test (6MWT) evaluates sub-maximal exercise responses. It's becoming more common in clinical studies, especially in situations of cardiopulmonary diseases like cystic fibrosis, where the patient's exercise ability and amount of physical activity are limited. It's used to assess functional capacity, conduct epidemiologic research, track the success of therapies, and predict morbidity and death for prognosis. The 6MWT is also regarded as a low-cost, easily repeatable outpatient test with high reliability and clinical use.

  4 Weeks

• CFQ-R14+

  Quality of life was measured by using the disease-specific health-related QoL questionnaire, CFQ-R 14+ The CFQ-R 14+ consists of 49 self-reported items within 12 domains: physical functioning , Vitality, emotional functioning, eating disturbances, treatment burden, general health perception, social functioning , body image, role limitations, weight problems, respiratory symptoms , digestive symptoms.

  4 Weeks

• Borg Scale

  Borg scale is a validated indicator of the intensity of acute dyspnea. It ranges from 0 to 10 where a value of 0 represents "nothing at all", 5 is synonymous with "severe" and 10 signifies "maximal dyspnea".

  4 Weeks

Study Arms (1)

Treatment Group

EXPERIMENTAL

There will be one group, and study will be Quasi Experimental Study. Treatment will be given to all 28 participants, 3 sessions in a week for 4 weeks. Pre and Post treat-meant evaluation will be checked by CFQR+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.

Other: Exercise

Interventions

Exercise OTHER

There will be one group, and study will be Quasi Experimental Study. Treatment will be given to all 28 participants, 3 sessions in a week for 4 weeks. Pre and Post treat-meant evaluation will be checked by CFQR+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.

Treatment Group

Eligibility Criteria

• Age: 14 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Bahria International Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (7)

• 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.

  PMID: 27378490 BACKGROUND

• 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.

  PMID: 32115388 BACKGROUND

• 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.

  PMID: 22788948 BACKGROUND

• 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.

  PMID: 24884656 BACKGROUND

• 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.

  PMID: 21069699 BACKGROUND

• 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.

  PMID: 20667149 BACKGROUND

• 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.

  PMID: 27311438 BACKGROUND

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Exercise

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Hafiza Muriam Ghani, MSCPPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2022
• First Posted: December 19, 2022
• Study Start: June 1, 2022
• Primary Completion: January 30, 2023
• Study Completion: January 30, 2023
• Last Updated: February 1, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)