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

Primary Purpose

Cystic Fibrosis Patients

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Exercise
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis Patients focused on measuring Cystic Fibrosis, Active cycle Breathing technique, 6 minute walk test, Borg scale, Quality of life

Eligibility Criteria

14 Years - 50 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Bahria International Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Group

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
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".

Secondary Outcome Measures

Full Information

First Posted
December 9, 2022
Last Updated
January 31, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05655637
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
January 30, 2023 (Actual)
Study Completion Date
January 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis Patients
Keywords
Cystic Fibrosis, Active cycle Breathing technique, 6 minute walk test, Borg scale, Quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
6-min walk test (6MWT)
Description
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.
Time Frame
4 Weeks
Title
CFQ-R14+
Description
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.
Time Frame
4 Weeks
Title
Borg Scale
Description
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".
Time Frame
4 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hafiza Muriam Ghani, MSCPPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bahria International Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27378490
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.
Results Reference
background
PubMed Identifier
32115388
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.
Results Reference
background
PubMed Identifier
22788948
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.
Results Reference
background
PubMed Identifier
24884656
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.
Results Reference
background
PubMed Identifier
21069699
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.
Results Reference
background
PubMed Identifier
20667149
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.
Results Reference
background
PubMed Identifier
27311438
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.
Results Reference
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Effects of Breathing Exercises Combined With Endurance and Strength Training in Patients With Cystic Fibrosis.

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