The Effects of Yoga Practice on Exercise Capacity, Arterial Stiffness, Respiratory Function, Peripheral Muscle Strength, Posture and Quality of Life in Children With Cystic Fibrosis
The aim of this study is to investigate the effects of exercise training applied through telerehabilitation on exercise capacity, peripheral and respiratory muscle strength, arterial stiffness, posture and quality of life in children with cystic fibrosis.
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
The most common problems in patients with cystic fibrosis (CF) are increased bronchial secretions, reduced exercise tolerance and shortness of breath.
Exercise capacity is limited due to muscle dysfunction, inflammation and progressive respiratory disease. Cardiovascular complications are one of the long-term complications of CF. Increased arterial stiffness is an indicator of elevated cardiovascular risk. It has been shown that patients with CF have increased arterial stiffness compared to their healthy peers.
Exercise training has a positive effect on exercise capacity, respiratory function and quality of life in patients with CF. Studies have shown that exercise training applied using the telerehabilitation method increases exercise capacity and improves peripheral muscle function in patients with CF. Peripheral muscle function, functional capacity, arterial stiffness and posture have been assessed in patients with CF. Furthermore, studies have been performed on patients with CF involving exercise training via telerehabilitation.In addition, various studies have shown that yoga and aerobic exercise training have positive effects on arterial stiffness. Although there are only a few studies involving patients with CF who practise yoga, no study has been found that assesses the effects of yoga practise via telerehabilitation on exercise capacity, peripheral and respiratory muscle function, and arterial stiffness.The purpose of this study is to examine the effects of exercise training using telerehabilitation on exercise capacity, peripheral and respiratory muscle strength, arterial stiffness, posture and quality of life in children with CF.
Children were randomly assigned to three groups: The first group will receive online aerobic exercise training and yoga sessions. The second group will receive only aerobic exercise training.The third group will be informed about the importance of physical activity and will be given recommendations for physical activity. Participants' respiratory function, exercise capacity, arterial stiffness parameters, peripheral muscle function, posture and quality of life questionnaire will be evaluated initially and following an 8-week exercise programme.
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Naciye Vardar-Yagli, PhD
- Phone Number: +903123051576 ext 129
- Email: naciyevardar@yahoo.com
Study Locations
-
-
-
Ankara, Turkey (Türkiye), 06100
- Recruiting
- Hacettepe University
-
Contact:
- Naciye Vardar-Yagli, PhD
- Phone Number: +903123051576
- Email: naciyevardar@yahoo.com
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients aged 8-18 years with a diagnosis of cystic fibrosis (CF)
- Access to online exercise training
- Percent predicted of forced expiratory volume at one second (FEV1) > 40% in pulmonary function test
Exclusion Criteria:
- Being diagnosed with acute pulmonary exacerbation at the time of study and /or within the last month.
- Being physically or perceptually competent to exercise
- Patients with allergic bronchopulmonary aspergillosis who were treated with systemic steroid therapy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Combined Group
aerobic exercise training and yoga sessions in patients with cystic fibrosis |
Patients will be performed online in groups of 3-4 participants supervised aerobic exercises and yoga sessions. Aerobic exercises will be applied for 8 weeks, for 30-45 minutes, at 65-75% of the maximum heart rate, 3 days a week, on the days when yoga sessions are not performed. The yoga sessions will consist of 30-40-minute sessions, with three sessions per week for eight weeks. The yoga sessions will consist of three core components - asana (postures), pranayama (breathing) and meditation (focus). |
|
Experimental: aerobic group
only aerobic exercises in patients with cystic fibrosis |
Patients will be performed online in groups of 3-4 participants supervised only aerobic exercises Aerobic exercises will be applied for 8 weeks, for 30-45 minutes, at 65-75% of the maximum heart rate, 3 days a week. |
|
Experimental: control group
physical activity recommendations in patients with cystic fibrosis |
Patients will be informed of the benefits of physical activity and appropriate physical activity recommendations will be provided. |
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
six minute walk test
Time Frame: before the exercise training
|
the distance reached in the six-minute walk test |
before the exercise training
|
|
six minute walk test
Time Frame: eigth week
|
the distance reached in the six-minute walk test |
eigth week
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Arterial stiffness
Time Frame: before the exercise training
|
Arterial stiffness will be assessed non-invasively using the Mobil-O-GRAPH (I.E.M., Stolberg, Germany). |
before the exercise training
|
|
Arterial stiffness
Time Frame: eight week
|
Arterial stiffness will be assessed non-invasively using the Mobil-O-GRAPH (I.E.M., Stolberg, Germany). |
eight week
|
|
Respiratory muscle strength
Time Frame: before the exercise training
|
Respiratory muscle strength will be evaluated using mouth pressure device |
before the exercise training
|
|
Respiratory muscle strength
Time Frame: eight week
|
Respiratory muscle strength will be evaluated using mouth pressure device |
eight week
|
|
respiratory muscle endurance
Time Frame: before the exercise training
|
Respiratory muscle endurance will be assessed using constant load test |
before the exercise training
|
|
respiratory muscle endurance
Time Frame: eight week
|
Respiratory muscle endurance will be assessed using constant load test |
eight week
|
|
Pulmonary functions-FVC
Time Frame: before the exercise training
|
Forced vital capacity (FVC) |
before the exercise training
|
|
Pulmonary functions-FVC
Time Frame: eight week
|
Forced vital capacity (FVC) |
eight week
|
|
Pulmonary functions-FEV1
Time Frame: before the exercise training
|
Forced expiratory volume in the first second (FEV1) |
before the exercise training
|
|
Pulmonary functions-FEV1
Time Frame: eigth week
|
Forced expiratory volume in the first second (FEV1) |
eigth week
|
|
Pulmonary functions-FEV1/FVC
Time Frame: before the exercise training
|
FEV1/ FVC |
before the exercise training
|
|
Pulmonary functions-FEV1/FVC
Time Frame: eight week
|
FEV1/ FVC |
eight week
|
|
Pulmonary functions-FEF25-75
Time Frame: before the exercise training
|
Forced mid-expiratory flow (FEF25-75) |
before the exercise training
|
|
Pulmonary functions-FEF25-75
Time Frame: eigth week
|
Forced mid-expiratory flow (FEF25-75) |
eigth week
|
|
Peripheral muscle strength
Time Frame: before the exercise training
|
Peripheral muscle strength will be assessed using dynamometer |
before the exercise training
|
|
Peripheral muscle strength
Time Frame: eigth week
|
Peripheral muscle strength will be assessed using dynamometer |
eigth week
|
|
1 minute sit to stand test (STS) repetitions
Time Frame: before the exercise training
|
number of sit to stand for one minute is recorded |
before the exercise training
|
|
1 minute sit to stand test (STS) repetitions
Time Frame: eight week
|
number of sit to stand for one minute is recorded |
eight week
|
|
posture
Time Frame: before the exercise training
|
Posture will be assessed using Corbin Postural Assessment scale. Lateral and posterior views will be assessed (0 = absent,1 = mild, 2 = moderate, 3 = severe) and posture score will be determined as excellent(0-2), very good (3-4), good (5-7), fair (8-11)and poor (>12). |
before the exercise training
|
|
posture
Time Frame: eigth week
|
Posture will be assessed using Corbin Postural Assessment scale. Lateral and posterior views will be assessed (0 = absent,1 = mild, 2 = moderate, 3 = severe) and posture score will be determined as excellent(0-2), very good (3-4), good (5-7), fair (8-11)and poor (>12). |
eigth week
|
|
Quality of life assessment
Time Frame: before the exercise training
|
Quality of life will be assessed using the Cystic Fibrosis Questionnaire-Revised .The Cystic Fibrosis Questionnaire-Revised is a disease-specific health-related quality of life measure for children, adolescents with cystic fibrosis (CF). The questionnaire evaluate physical functioning, emotional functioning, social functioning, body image, eating disorders, treatment,respiratory symptoms and digestive symptoms. Score range is 0-100. Higher scores indicating higher health-related qualityof life. |
before the exercise training
|
|
Quality of life assessment
Time Frame: eigth week
|
Quality of life will be assessed using the Cystic Fibrosis Questionnaire-Revised .The Cystic Fibrosis Questionnaire-Revised is a disease-specific health-related quality of life measure for children, adolescents with cystic fibrosis (CF). The questionnaire evaluate physical functioning, emotional functioning, social functioning, body image, eating disorders, treatment,respiratory symptoms and digestive symptoms. Score range is 0-100. Higher scores indicating higher health-related quality of life. |
eigth week
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Naciye Vardar-Yagli, PhD, Hacettepe University
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Genetic Diseases, Inborn
- Respiratory Tract Diseases
- Digestive System Diseases
- Lung Diseases
- Infant, Newborn, Diseases
- Pancreatic Diseases
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Behavior
- Cystic Fibrosis
- Motor Activity
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Therapeutics
- Mind-Body Therapies
- Complementary Therapies
- Spiritual Therapies
- Exercise Movement Techniques
- Physical Therapy Modalities
- Exercise
- Yoga
Other Study ID Numbers
Other Study ID Numbers
- FTREK25/92
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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