The Effects of a Tele-rehabilitation-Guided Qigong Exercise Program on Pulmonary Function, Functional Capacity, and Symptom Control in Children and Adolescents With Asthma: A Randomized Controlled Trial
| Registry | NCT07883967, acronym Qigong-PedAsth |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, supportive care |
| Enrollment | 40 (Estimated) |
| Sponsor | Antalya Health Sciences University (Other) |
| Conditions | Asthma Childhood |
| Interventions | Tele-rehabilitation-guided Qigong (Behavioral) |
| Dates | start 2026-10-15 (estimated), primary completion 2027-05-30 (estimated), completion 2027-08-30 (estimated), first posted 2026-10-20, last updated 2026-10-20 |
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This study investigates the effects of a tele-rehabilitation-guided Qigong exercise program on pulmonary function, functional exercise capacity, and symptom control in children and adolescents with mild-to-moderate asthma.
Participants aged 8 to 18 years will be randomly assigned to either an intervention group or a control group. The intervention group will participate in an 8-week, home-based, tele-rehabilitation-supervised Qigong exercise program in addition to standard medical care. The control group will continue receiving standard medical treatment and routine follow-up.
The primary aim of the study is to evaluate changes in pulmonary function (spirometric parameters such as FEV1 and FVC) and functional exercise capacity measured by the 6-Minute Walk Test (6MWT). Secondary outcomes include asthma symptom control assessed via the Asthma Control Test (ACT/c-ACT) and health-related quality of life.
Pediatric asthma is a prevalent chronic inflammatory airway disease associated with significant morbidity, impaired functional exercise tolerance, and reduced quality of life. While pharmacotherapy represents the cornerstone of management, complementary non-pharmacological interventions, including mind-body exercises, are increasingly recognized for their potential benefits in improving respiratory mechanics and symptom control.
This single-center, randomized controlled clinical trial evaluates the feasibility and therapeutic efficacy of an 8-week tele-rehabilitation-delivered Qigong program in pediatric patients diagnosed with asthma according to GINA guidelines.
Eligible participants will be randomized in a 1:1 ratio into two groups:
1. Intervention Group: Participants will undergo supervised online group Qigong sessions led by experienced rehabilitation specialists, complemented by structured home-practice routines, alongside routine asthma medical maintenance.
2. Control Group: Participants will maintain standard asthma pharmacological therapy with conventional clinical follow-up without structured exercise intervention.
Baseline and post-intervention assessments (at week 8) will include spirometry (FEV1, FVC, FEV1/FVC ratio, FEF25-75), functional exercise tolerance evaluated using the standardized 6-Minute Walk Test (6MWT), asthma control level assessed using the Asthma Control Test (ACT) or Childhood Asthma Control Test (c-ACT), and pediatric health-related quality of life scores. Adherence, safety, and adverse events will be monitored throughout the study period.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Intervention Group | Experimental | Behavioral: Tele-rehabilitation-guided Qigong | Participants receive an 8-week tele-rehabilitation-supervised Qigong exercise program in addition to standard medical asthma care. |
| Control Group | No intervention | Participants receive standard medical asthma care and routine clinical follow-up without any structured exercise program. |
Sex: All, ages: 8 Years to 17 Years
Inclusion Criteria: * Physician-confirmed diagnosis of asthma according to international guidelines (e.g., GINA criteria) for at least 6 months. * Age between 8 and 18 years at the time of enrollment. * Clinically stable asthma with no severe exacerbation or change in maintenance controller therapy in the past 4 weeks. * Ability to perform standard spirometry and functional exercise tests. * Access to an internet-connected device (smartphone, tablet, or computer) suitable for tele-rehabilitation video sessions. * Signed written informed consent by parent/legal guardian and assent by the child/adolescent. Exclusion Criteria: * Diagnosis of other chronic lung diseases (e.g., cystic fibrosis, bronchiectasis, primary ciliary dyskinesia). * Significant musculoskeletal, cardiovascular, or neurological disorders that impair the ability to perform physical exercise. * Recent systemic corticosteroid use or hospitalization due to an acute asthma exacerbation within the last 4 weeks. * Regular participation in structured mind-body practices (such as Qigong, Tai Chi, or Yoga) within the past 3 months. * Inability to comply with the study protocol or follow tele-rehabilitation instructions.