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Evaluation of the Effect of Yoga Training on Functional Capacity and Quality of Life in Patients With Bronchiectasis

Primary Purpose

Bronchiectasis Adult

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Yoga Training Program (exercises)
Sponsored by
Istanbul Medipol University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiectasis Adult focused on measuring Yoga Training, Quality of Life, Functional Capacity, Bronchiectasis

Eligibility Criteria

30 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosed with bronchiectasis
  • Age 30-55
  • Not having a known systemic, orthopedic or neurological disease

Exclusion Criteria:

  • Severe heart failure
  • People who had an acute exacerbation up to three weeks ago will not be included in the study

Sites / Locations

  • Istanbul Medipol University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Yoga Training Group

Control group

Arm Description

Training: Before the yoga program, the patients will be informed about the bronchiectasis disease and its symptoms, as well as all the parameters used in the evaluation, tests and the content of the yoga session. During the program, the perceived fatigue intensity of the patients will be questioned with the Modified Borg Scale. Yoga Session 1-8 weeks and duration Breathing Exercises 5 min Instant Relaxation Technique 2 min Warm-up Exercises 10 min Quick Relaxation Technique 3 min Asanas (Posture Exercises) 15 min Alternative Breathing Exercises 10 min Deep Relaxation Technique 3 min

Training: The exercise program will include respiration exercises that they can do at home. Before the exercise program, the patients will be informed about the bronchiectasis disease and its symptoms, as well as all the parameters and tests used in the evaluation. Respiratory control, breathing exercises, relaxation techniques and the reasons, importance and effects of exercise training in the treatment program will be explained. Breathing Exercises (10 min) Pursed-lip breathing training, Chest breathing exercise (10 repetitions), Diaphragmatic breathing exercise (10 repetitions), Bilateral basal expansion breathing exercises (10 repetitions)

Outcomes

Primary Outcome Measures

Patient Follow-up Form
The demographic characteristics, physical characteristics such as age, height and body weight of the individuals included in the study and their education status will be recorded.

Secondary Outcome Measures

Dyspnea Assessment
Dyspnea will be assessed by the modified Medical Research Council (MMRC) dyspnea scale. Individuals will be asked to choose the statement that best describes their dyspnea level. Scoring in MMRC varies between 0-4 points. "0 points" means that there is no dyspnea; "4 points" indicates a perception of dyspnea during basic daily life activities such as dressing.

Full Information

First Posted
January 21, 2021
Last Updated
January 9, 2023
Sponsor
Istanbul Medipol University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04744220
Brief Title
Evaluation of the Effect of Yoga Training on Functional Capacity and Quality of Life in Patients With Bronchiectasis
Official Title
Evaluation of the Effect of Yoga Training on Functional Capacity and Quality of Life in Patients With Bronchiectasis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
November 25, 2020 (Actual)
Primary Completion Date
November 20, 2022 (Actual)
Study Completion Date
December 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istanbul Medipol University Hospital

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
Evaluation of the Effect of Yoga Training on Functional Capacity and Quality of Life in Patients with Bronchiectasis between the ages of 30-55
Detailed Description
Investigating the effect of yoga training on functional capacity and quality of life and comparing with previous studies

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiectasis Adult
Keywords
Yoga Training, Quality of Life, Functional Capacity, Bronchiectasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
The cases will be randomly divided into two groups as 24 control groups and 24 yoga training groups
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Yoga Training Group
Arm Type
Experimental
Arm Description
Training: Before the yoga program, the patients will be informed about the bronchiectasis disease and its symptoms, as well as all the parameters used in the evaluation, tests and the content of the yoga session. During the program, the perceived fatigue intensity of the patients will be questioned with the Modified Borg Scale. Yoga Session 1-8 weeks and duration Breathing Exercises 5 min Instant Relaxation Technique 2 min Warm-up Exercises 10 min Quick Relaxation Technique 3 min Asanas (Posture Exercises) 15 min Alternative Breathing Exercises 10 min Deep Relaxation Technique 3 min
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Training: The exercise program will include respiration exercises that they can do at home. Before the exercise program, the patients will be informed about the bronchiectasis disease and its symptoms, as well as all the parameters and tests used in the evaluation. Respiratory control, breathing exercises, relaxation techniques and the reasons, importance and effects of exercise training in the treatment program will be explained. Breathing Exercises (10 min) Pursed-lip breathing training, Chest breathing exercise (10 repetitions), Diaphragmatic breathing exercise (10 repetitions), Bilateral basal expansion breathing exercises (10 repetitions)
Intervention Type
Other
Intervention Name(s)
Yoga Training Program (exercises)
Intervention Description
Training: Before the yoga program, the patients will be informed about the bronchiectasis disease and its symptoms, as well as all the parameters used in the evaluation, tests and the content of the yoga session. The patients will start with breathing exercises, then relaxation exercises, warm-up exercises, asanas (posture exercises) and finally the yoga training program will be completed with deep relaxation technique.
Primary Outcome Measure Information:
Title
Patient Follow-up Form
Description
The demographic characteristics, physical characteristics such as age, height and body weight of the individuals included in the study and their education status will be recorded.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Dyspnea Assessment
Description
Dyspnea will be assessed by the modified Medical Research Council (MMRC) dyspnea scale. Individuals will be asked to choose the statement that best describes their dyspnea level. Scoring in MMRC varies between 0-4 points. "0 points" means that there is no dyspnea; "4 points" indicates a perception of dyspnea during basic daily life activities such as dressing.
Time Frame
Before and after treatment (8 week)
Other Pre-specified Outcome Measures:
Title
Respiratory Function Test
Description
A spirometer will be used to evaluate the lung function of individuals. It will be expressed as a percentage of the expected values by age, height, body weight and gender.
Time Frame
Before and after treatment( 8 week )
Title
Quality of Life Assessment
Description
Quality of life, St. George's Respiratory Questionnaire (SGRQ). SGRQ is a health-related quality of life questionnaire that questions a total of 50 items under 3 main components: symptoms (8 items), activity (16 items) and effects of disease (26 items). The symptoms component includes the frequency and duration of symptoms such as cough, sputum, shortness of breath, wheezing. The activity component relates to physical activities that are restricted due to shortness of breath. It includes factors such as the effects component of the disease, the drugs used and its side effects, the individual's expectations for health and the discomfort they face in daily life. The total score is between 0-100. The higher the score, the lower the quality of life
Time Frame
Before and after treatment (8 week)
Title
Evaluation of Functional Capacity
Description
Individuals' functional capacity will be evaluated with the six-minute walking test (6MWT). During the 6MWT, individuals are asked to walk in a straight corridor of 30 meters as fast as possible, at their own walking pace in standard directions. At the end of the test, the walking distance is recorded in meters.
Time Frame
Before and after treatment (8 week)
Title
Assessment of Sleep Quality
Description
Pittsburgh Sleep Quality Index (PSQI) will be used to evaluate the sleep quality of the individuals participating in our study before and after the 8-week study period. PSQI is a test that plays a role in determining sleep quality and sleep-related disorders in the last month. It is a scale consisting of 19 self-report items, a total of 24 questions with a score range of 0-21, and the remaining five questions must be answered by a roommate or a spouse. It is a test that evaluates a wide variety of areas related to sleep quality, including components, sleep time, delays in falling asleep, the frequency and severity of sleep-related problems, and the impact of poor sleep on an individual's work.
Time Frame
Before and after treatment (8 week)

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with bronchiectasis Age 30-55 Not having a known systemic, orthopedic or neurological disease Exclusion Criteria: Severe heart failure People who had an acute exacerbation up to three weeks ago will not be included in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salih Tan
Organizational Affiliation
Istanbul Medipol University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul Medipol University Hospital
City
Istanbul
ZIP/Postal Code
34000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of the Effect of Yoga Training on Functional Capacity and Quality of Life in Patients With Bronchiectasis

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