- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07411040
Effects of Body Awareness Therapy on Physical and Psychosocial Outcomes in Adults With Asthma
Effect of Body Awareness Therapy on Physical and Psychosocial Outcomes in Adults With Asthma: A Randomized Controlled Trial
This study aims to investigate the effects of Body Awareness Therapy on physical and psychosocial outcomes in adults with asthma. Asthma is a chronic respiratory condition that can affect breathing, physical activity, and emotional well-being. In addition to medical treatment, non-pharmacological approaches that support body awareness and breathing may help individuals manage their symptoms more effectively.
Participants in this study will be randomly assigned to either a Body Awareness Therapy group or a control group receiving standard care. The Body Awareness Therapy program includes guided exercises focusing on posture, breathing, movement, and awareness of bodily sensations. The program will be delivered over several weeks by a trained physiotherapist.
The main outcomes of the study include physical function, respiratory symptoms, quality of life, psychological well-being, and body awareness levels. The results of this study are expected to provide evidence on whether Body Awareness Therapy can be an effective supportive approach in asthma management and rehabilitation.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study is designed to evaluate the effectiveness of Body Awareness Therapy as a complementary intervention for adults with asthma. Asthma is a chronic inflammatory airway disease that not only affects respiratory function but is also associated with reduced physical capacity, increased symptom perception, psychological distress, and decreased quality of life. While pharmacological treatment is essential for asthma management, many individuals continue to experience persistent symptoms and psychosocial challenges despite optimal medical care.
Body Awareness Therapy is a mind-body approach that emphasizes conscious attention to bodily sensations, breathing patterns, posture, and movement. The therapy aims to improve self-regulation, enhance interoceptive awareness, and promote more efficient and relaxed breathing. Previous research in other chronic conditions suggests that body-based interventions may positively influence physical function, symptom perception, emotional well-being, and coping strategies. However, evidence regarding the use of Body Awareness Therapy in individuals with asthma remains limited.
In this randomized controlled trial, eligible participants will be randomly allocated to either a Body Awareness Therapy group or a control group receiving standard care. The intervention will consist of supervised sessions conducted by a trained physiotherapist over a predefined period. The sessions will include guided exercises focusing on breathing awareness, postural alignment, gentle movement, and attention to bodily sensations. Participants will also be encouraged to apply these principles in daily life.
The primary outcomes of the study include physical function and asthma-related symptoms. Secondary outcomes include psychological well-being, quality of life, and levels of body awareness. Outcome measures will be assessed at baseline and after completion of the intervention period.
The findings of this study are expected to contribute to the growing field of non-pharmacological and mind-body interventions in respiratory rehabilitation. If effective, Body Awareness Therapy may represent a low-cost, safe, and accessible supportive approach to improve both physical and psychosocial health in individuals with asthma.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults aged between 18 and 65 years.
- Clinically diagnosed asthma confirmed by a physician.
- Stable asthma condition (no acute exacerbation in the last 4 weeks).
- Receiving regular medical treatment for asthma.
- Able to understand and follow instructions for the intervention.
- Willing to participate and provide written informed consent.
Exclusion Criteria:
- Diagnosis of chronic respiratory diseases other than asthma (e.g., COPD, bronchiectasis).
- Acute asthma exacerbation within the last 4 weeks.
- Severe cardiovascular, neurological, or musculoskeletal conditions that may limit participation in physical activity.
- Current participation in another structured exercise or rehabilitation program.
- History of major psychiatric disorders that may interfere with participation (e.g., psychotic disorders).
- Pregnancy.
- Cognitive impairment affecting the ability to follow instructions.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Body Awareness Therapy Group
Participants will receive a structured Body Awareness Therapy program delivered by a trained physiotherapist.
|
A structured Body Awareness Therapy program delivered by a trained physiotherapist, including guided exercises focusing on breathing awareness, posture, gentle movement, and attention to bodily sensations.
Participants will continue their usual medical care for asthma without additional body awareness intervention.
|
|
Active Comparator: Standard Care Control Group
Participants will receive standard medical care for asthma without additional body awareness intervention.
|
Participants will continue their usual medical care for asthma without additional body awareness intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Six-Minute Walk Test Distance
Time Frame: Baseline (Week 0) and Post-intervention (Week 8)
|
Physical function will be assessed using the Six-Minute Walk Test (6MWT). Total walking distance covered in six minutes will be recorded. (Units of Measure: Meters) |
Baseline (Week 0) and Post-intervention (Week 8)
|
|
Asthma Control Test Total Score
Time Frame: Baseline (Week 0) and Post-intervention (Week 8)
|
Asthma symptom severity will be assessed using the Turkish Asthma Control Test (T-ACT).
The total questionnaire score will be analyzed.
|
Baseline (Week 0) and Post-intervention (Week 8)
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2026/01-1819
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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