Effects of Pulmonary Rehabilitation on Clinical Outcomes in Children With Asthma

NCT ID: NCT06141616

Last Updated: 2023-11-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-31
• Study Completion Date: 2025-01-31

Brief Summary

Although the practice of physical activity is recommended for children with asthma, the scientific literature available so far has focused mainly on improving functional capacity and quality of life. However, the effects of pulmonary rehabilitation in this population, especially in improving the level of physical activity in daily living (PADL) and activities of daily living (ADLs) have not yet been investigated in depth. Therefore, the objective of this study is to verify the effects of pulmonary rehabilitation on PADL, ADL, and other clinical outcomes of children with asthma. For this, a randomized clinical trial will be carried out that will have 2 groups: the control group (CG), which will receive only educational sessions, and the intervention group (IG) which will participate in a pulmonary rehabilitation program with supervised aerobic training performed three times a week with sessions of 60 minutes each. The total duration of interventions in both groups will be 12 weeks. The primary outcomes of this study are PADL (assessed using a physical activity monitor - Actigraph) and ADL; however, the following will also be evaluated: lung function, functional capacity, asthma control, and quality of life. We hypothesized that the performance of regular physical activity and supervised physical exercise by individuals with asthma could positively impact health outcomes with better control of asthma symptoms, better performance in ADL and PADL, and better quality of life.

Conditions

Asthma in Children; Physical Inactivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control group

Sessions once a week, covering information about the pathophysiology of asthma, medication instructions, self-monitoring techniques, environmental control techniques, and prevention strategies for children, adolescents, and families. They will also receive physical activity recommendations, as well as information about the importance and benefits of being physically active and maintaining a healthy lifestyle. The sessions will feature educational and playful videos, presentations, and participants will be able to clarify their doubts about the topic addressed.

Group Type: SHAM_COMPARATOR

Asthma Rehabilitation Program

Intervention Type: OTHER

The group will receive free physiotherapy treatment with aerobic exercises, 3x/week, 60 minutes a day, lasting 3 months, in addition to educational sessions in a playful way.

Experimental group

Rehabilitation program performed 3x/week. Each session will last 60 minutes, with a minimum interval of 24 hours, for a period of three months. The main focus of the intervention is aerobic training, which will be carried out in three stages, treadmill with a warm-up (10 minutes), load (20 minutes), and cool-down (5 minutes). With an initial intensity of 65% of the maximum load obtained in the incremental shuttle walk test (ISWT). The intensity will be gradually increased up to 115%, keeping dyspnea and fatigue values between 4 and 6, according to the modified Borg scale. In addition, we will do a circuit focused on aerobic activities, maintaining target heart rate during its performance for 20 minutes. When necessary, supplemental oxygen will be provided during training. Volunteers in this group will receive a bronchodilator dose before starting each day's session. This group will hold educational sessions as well.

Group Type: EXPERIMENTAL

Asthma Rehabilitation Program

Intervention Type: OTHER

The group will receive free physiotherapy treatment with aerobic exercises, 3x/week, 60 minutes a day, lasting 3 months, in addition to educational sessions in a playful way.

Interventions

Asthma Rehabilitation Program

The group will receive free physiotherapy treatment with aerobic exercises, 3x/week, 60 minutes a day, lasting 3 months, in addition to educational sessions in a playful way.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age between 6 and 12 years old;
• Clinical diagnosis of asthma, established according to the criteria of the Global Initiative for Asthma (GINA);
• Absence of other lung diseases or signs and symptoms of other lung diseases;
• Absence of cognitive changes;
• Absence of signs and symptoms of gastroesophageal reflux disease and dysphagia;
• Clinical stability according to the criteria of the Global Initiative for Asthma (GINA);

Exclusion Criteria

• Desire of the patient and/or the patient's family to discontinue participation in the study for any reason;
• Present some new limitations that may interfere with functionality;
• Comorbidities that prevent or contraindicate the performance of the proposed interventions.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Norte do Paraná

OTHER

Sponsor Role: lead

Responsible Party

Karina Furlanetto

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vitória Puzzi, Msc

Role: PRINCIPAL_INVESTIGATOR

Universidade Norte do Paraná

Locations

Centro de Pesquisa e Pós Graduação na Unopar

Londrina, Paraná, Brazil

Countries

Brazil

Central Contacts

Karina Furlanetto, PhD

Role: CONTACT

ka_furlanetto@hotmail.com

+55 43 991144621

Other Identifiers

PuzziVC_PhD_FurlanettoKC

Identifier Type: -

Identifier Source: org_study_id