Effects of Tele-rehabilitation-Guided Qigong on Children and Adolescents With Asthma

NCT07883967 — Not applicable, Not yet recruiting, 40 participants, Antalya Health Sciences University

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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

RegistryNCT07883967, acronym Qigong-PedAsth
StatusNot yet recruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, supportive care
Enrollment40 (Estimated)
SponsorAntalya Health Sciences University (Other)
ConditionsAsthma Childhood
InterventionsTele-rehabilitation-guided Qigong (Behavioral)
Datesstart 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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-Summary

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.

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+Detailed description

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.

+Arms and interventions

ArmTypeInterventionsDescription
Intervention GroupExperimentalBehavioral: Tele-rehabilitation-guided QigongParticipants receive an 8-week tele-rehabilitation-supervised Qigong exercise program in addition to standard medical asthma care.
Control GroupNo interventionParticipants receive standard medical asthma care and routine clinical follow-up without any structured exercise program.
  • Tele-rehabilitation-guided Qigong (Behavioral): An 8-week home-based Qigong exercise program delivered and supervised via tele-rehabilitation sessions in addition to standard medical asthma care.

+Outcome measures

Primary outcomes

  • Change from Baseline in Forced Expiratory Volume in 1 Second (FEV1) [Baseline and Week 8]: Assessed by standard spirometry. FEV1 will be measured in liters and reported as percent of predicted value according to international pediatric respiratory guidelines.
  • Change from Baseline in 6-Minute Walk Distance (6MWD) [Baseline and Week 8]: Functional exercise capacity evaluated by the standardized 6-Minute Walk Test (6MWT), measuring the total distance walked in meters in 6 minutes.

Secondary outcomes

  • Change from Baseline in 6-Minute Walk Distance (6MWD) [Baseline and Week 8]: Assessed using the standardized 6-Minute Walk Test (6MWT). Total distance walked in meters within 6 minutes will be recorded to evaluate functional exercise capacity.
  • Change from Baseline in Asthma Control Test (ACT) Score [Baseline and Week 8]: Assessed using the Asthma Control Test (ACT) for adolescents (≥12 years) or Childhood Asthma Control Test (c-ACT) for children (<12 years). Higher scores indicate better symptom control.
  • Change from Baseline in Pediatric Asthma Quality of Life Questionnaire (PAQLQ) Score [Baseline and Week 8]: Assessed via the standardized Pediatric Asthma Quality of Life Questionnaire. Evaluates physical activity limitation, symptoms, and emotional function related to asthma.

+Eligibility

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.