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Cystic Fibrosis PatientsNCT05655637

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

A study testing Exercise in people with Cystic Fibrosis Patients, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 14 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Cystic Fibrosis Patients
What is being tested?
Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 sitePakistan
Study dates
1 Jun 2022to 30 Jan 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Bahria International Hospital

    Lahore, Punjab Province, 54000

Other trials in Pakistan

About this study

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.

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.

Being tested
Exercise
Keywords
Cystic Fibrosis, Active cycle Breathing technique, 6 minute walk test, Borg scale, Quality of life
Medical subject headings
Cystic Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExerciseOther

    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.

Study groups in NCT05655637
Study groupRoleWhat they receive
Treatment GroupExperimentalThere 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.
Receives: Other: Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 4 Weeks

  2. 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.

    Measured: 4 Weeks

  3. 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".

    Measured: 4 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2022
  2. Study start1 Jun 2022
  3. Primary completion30 Jan 2023
  4. Study completion30 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05655637
Sponsor's protocol ID
REC/RCR&AHS/22/0342
Status last verified
Jan 2023
First submitted
9 Dec 2022
Last updated
1 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 27378490

  • 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.

    PubMed 32115388

  • 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.

    PubMed 22788948

  • 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.

    PubMed 24884656

  • 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.

    PubMed 21069699

  • 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.

    PubMed 20667149

  • 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.

    PubMed 27311438

Questions about this trial

What is this clinical trial studying?

A study testing Exercise in people with Cystic Fibrosis Patients, run by Riphah International University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6-min walk test (6MWT) (time frame: 4 Weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05655637, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2023.

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