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Completed

NCT Number: NCT05655637

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

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Key information

Conditions

Cystic Fibrosis Patients Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystic Fibrosis Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

14 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bahria International Hospital

Lahore, Punjab Province, 54000, Pakistan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 6-min walk test (6MWT)

    Time frame: 4 Weeks

    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.

  2. CFQ-R14+

    Time frame: 4 Weeks

    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.

  3. Borg Scale

    Time frame: 4 Weeks

    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".

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of Breathing Exercises Combined With Endurance and Strength Training on Dyspnea, Exercise Capacity and Quality of Life of Patients With Cystic Fibrosis.

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 19, 2022
Registry last updated
Feb 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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