NCT04088669

Brief Summary

Asthma is a serious global health problem affecting people of all ages in every country in the world. Despite the presence of effective medications, many studies have reported poor asthma control in patients. Therefore, new approaches are needed to improve asthma control. Pulmonary rehabilitation is recommended as an alternative approach in patients with chronic lung disease including asthma. Also, home-based type of pulmonary rehabilitation can be preferred because it is more cost-effective and patients can spend more time with their families. There are a limited number of studies in the literature evaluating the efficacy of home-based pulmonary rehabilitation in asthmatic patients. The aim of this study was to investigate the efficacy of home-based pulmonary rehabilitation program with simple equipment in asthmatic patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 25, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 13, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2019

Completed
Last Updated

January 9, 2026

Status Verified

January 1, 2026

Enrollment Period

9 months

First QC Date

September 10, 2019

Last Update Submit

January 7, 2026

Conditions

Keywords

asthmapulmonary rehabilitationhome-based pulmonary rehabilitationhome-based rehabilitation

Outcome Measures

Primary Outcomes (5)

  • Functional Capacity

    Change of Six-Minute Walking Test Distance from baseline to 8 weeks.The distance covered in meters in a straight corridor of 30 meters will be recorded as fast as possible but without running for 6 minutes. The distance that normal individuals should take in this period is 400-700 meters. In addition, oxygen saturation and heart rate, resting fatigue and dyspnea levels will be evaluated with pulse oximetry before and after testing. Modified Borg Dyspnea and Fatigue Scales will be used to determine resting dyspnea and fatigue levels.

    8 weeks

  • Peak Expiratory Flow

    Change of Expiratory Flow (PEF) from baseline to 8 weeks.

    8 weeks

  • Forced Expiratory Volume in 1 second

    Change of Forced Expiratory Volume in 1 second (FEV1) from baseline to 8 weeks.

    8 weeks

  • Control of Asthma

    Change of Asthma Control Test from baseline to 8 weeks. The Asthma Control Test is a 5-item questionnaire that enables the patient to assess his / her own level of exposure to asthma activities, frequency of day and night asthma symptoms, need for rescue medication, and disease control. Patients will be asked to answer the asthma control test, which includes scores associated with the answer to each question, and the total score will be 25 if complete control, 20-24 as partial control, and \<19 as uncontrolled.

    8 weeks

  • Dyspnoea

    Change of Medical Research Council Scale results from baseline to 8 weeks. The Medical Research Council Scale (MRCS) is a five-item scale based on various physical activities that produce dyspnea. Here, patients are asked to mark the level of activity that causes dyspnea in themselves. On the scale, 0 describes the best 4 dyspnea and the worst.

    8 weeks

Secondary Outcomes (3)

  • Lower Extremity Strength and Dynamic Balance

    8 weeks

  • Health Related Quality of Life

    8 weeks

  • Activity of Daily Living

    8 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

A home-based pulmonary rehabilitation program for 8 weeks, with a minimum of 3 days per week and one session of this is under the supervision of a physiotherapist.

Other: Home-based Pulmonary Rehabilitation

Control group

ACTIVE COMPARATOR

A training session about the disease and the correct inhaler use, booklets that include physical activity recommendations.

Other: Education and Recommendations

Interventions

Patients will admit a home-based pulmonary rehabilitation program for 8 weeks, with a minimum of 3 days per week and one session of this is under the supervision of a physiotherapist. The pulmonary rehabilitation program includes stretching exercises, strengthening exercises for upper and lower extremities, breathing exercises and aerobic exercises (walking). All of these exercises will be equipped with equipment that the patients can easily provide at home. In addition, patients will be provided with a pedometer and exercise diary.

Intervention group

The control group will be given a training session on the course of the disease and the correct inhaler use and will be given booklets on physical activity recommendations. Patients will be given a pedometer and diary.

Control group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with asthma
  • Acceptance of persons to participate in the study
  • Being in the 18-65 age range

You may not qualify if:

  • Presence of an orthopedic, neurological, systemic disease that prevents the exercise
  • Having mental, communicative and behavioral disorders that may cause problems in understanding commands and questions or practicing exercises.
  • Exercising 3 or more days a week

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bezmialem Vakıf University

Istanbul, Eyüp, Turkey (Türkiye)

Location

Bahçelievler Public Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Asthma

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Ayşe Sena Manzak, PhD Student

    Bezmialem Vakif University

    PRINCIPAL INVESTIGATOR
  • Semiramis Özyılmaz, Assoc. Prof.

    Bezmialem Vakif University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Asisstant, PhD

Study Record Dates

First Submitted

September 10, 2019

First Posted

September 13, 2019

Study Start

February 25, 2019

Primary Completion

November 10, 2019

Study Completion

November 10, 2019

Last Updated

January 9, 2026

Record last verified: 2026-01

Locations