Effects of Pulmonary Rehabilitation on Clinical Outcomes in Children With Asthma

NCT06141616 | Unknown

• 1 other identifier: PuzziVC_PhD_FurlanettoKC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Physical activity

  Number of steps per day, time spent (in minutes and percentage of the day) in light-intensity and moderate to vigorous physical activities, measured by a triaxial activity monitor.

  12 weeks from randomization

• Sedentary behavior

  Time spent (in minutes and percentage of the day) in sedentary activities, measured by a triaxial activity monitor.

  12 weeks from randomization

• The activity of daily living

  Time on a specific test to evaluate activities of daily living in children

  12 weeks from randomization

Secondary Outcomes (12)

• Initial assessment about general characteristics and health status

  12 weeks from randomization

• Pulmonary Function

  12 weeks from randomization

• Asthma Control

  12 weeks from randomization

• Exacerbation and medication diary

  12 weeks from randomization

• Quality of life in asthma

  12 weeks from randomization

Study Arms (2)

Control group

SHAM COMPARATOR

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.

Other: Asthma Rehabilitation Program

Experimental group

EXPERIMENTAL

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.

Other: Asthma Rehabilitation Program

Interventions

Asthma Rehabilitation Program 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.

Control group; Experimental group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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);

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Norte do Paraná: lead

Study Sites (1)

Centro de Pesquisa e Pós Graduação na Unopar

Londrina, Paraná, 86041-14, Brazil

Location

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Vitória Puzzi, Msc

  Universidade Norte do Paraná

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karina Furlanetto, PhD

CONTACT

+55 43 991144621; ka_furlanetto@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 11, 2023
• First Posted: November 21, 2023
• Study Start: December 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: January 1, 2025
• Last Updated: November 21, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)