- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03461887
Home-based Exercise Training for COPD Patients (HOMEX-1)
Effects of a Long-term Home-based Exercise Training Program Using Minimal Equipment vs. Usual Care in COPD Patients: a Multicenter Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
Exercise training is an important component of the management of chronic obstructive pulmonary disease (COPD) and numerous trials have shown large improvements in health-related quality of life (HRQoL) and exercise capacity in persons with COPD. However, the great majority of patients who would benefit from pulmonary rehabilitation (PR) never follow such a program. Moreover, many COPD patients are either not instructed to exercise at all or fail to adhere to exercise training at home after completing pulmonary rehabilitation.
This study evaluates an exercise training program that requires minimal equipment (i.e., only a chair and elastic bands) and can be easily implemented long-term in the patient's home-setting.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Barmelweid, Switzerland, 5017
- Klinik Barmelweid
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Heiligenschwendi, Switzerland, 3625
- Berner Reha Zentrum AG
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Wald, Switzerland, 8636
- Zürcher RehaZentren Wald
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Winterthur, Switzerland, 8401
- Kantonsspital Winterthur
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Zurich, Switzerland, 8001
- University of Zurich
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Signed informed consent after being informed
- Diagnosis of COPD, defined as forced expiratory volume in 1s/forced vital capacity (FEV1/FVC)<70% predicted, FEV1<80 % predicted after bronchodilation, with or without chronic symptoms (cough, sputum production) corresponding to a GOLD stage II-IV
- Completion of an inpatient or outpatient pulmonary rehabilitation not longer than 1 months ago
- Male and female patients ≥40 years of age
- Knowledge of German language to understand study material and assessments
Exclusion Criteria:
- Patients not able to conduct the exercise training program due to physical, cognitive or safety reasons, as judged by investigator; e.g., lower limb joint surgery within preceding 3 months, unstable cardiac disease, predominant neurological limitations.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exercise intervention
Home-based, minimal equipment exercise training program.
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Home-based exercise training program that requires only minimal equipment, and is individually adaptable to the participant's exercise level (6 times per week; 15-20 min; 38 exercise cards and one interactive training agenda booklet).
After randomization, a health care professional (HOMEX coach) will visit the intervention group participants at their home to set up the training location, to instruct the exercises and to establish individualized goals.
Follow-up visits are planned after 3 and 8-9 weeks.
Regular telephone calls will be conducted by the same HOMEX coach to motivate the patients, to discuss training progress and concrete benefits and barriers, and to adapt goals and the training program.
Additional intervention elements are that a relative or friend is involved as a "sparring" partner to support the participant.
The general practitioner is informed about the participation of his/her patient in the intervention.
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No Intervention: Control
Usual care (study participation does not have any impact on regular treatment or treatment decisions, including participation in other exercise training programs or rehabilitation programs)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dyspnea
Time Frame: Change from baseline to 12 months
|
Dyspnea domain of the Chronic Respiratory Questionnaire (CRQ); 5 questions; 7-point Likert-type scale ranging from 1 (most severe dyspnea) to 7 (no dyspnea)
|
Change from baseline to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dyspnea
Time Frame: Change from baseline to 3, 6 and 12 months
|
Dyspnea domain of the Chronic Respiratory Questionnaire (CRQ); 5 questions; 7-point Likert-type scale ranging from 1 (most severe dyspnea) to 7 (no dyspnea)
|
Change from baseline to 3, 6 and 12 months
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Exercise capacity
Time Frame: Change from baseline to 12 months
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Six-Minute Walk Test (walk distance) and 1-min Sit-to-Stand Test (number of repetitions) |
Change from baseline to 12 months
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Health-related quality of life
Time Frame: Change from baseline to 12 months
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Chronic Respiratory Questionnaires (CRQ): Fatigue, emotional function, mastery domain and EuroQoL (EQ-5D-5L): 5 Dimensions - Mobility, self-care, usual activities, pain/discomfort, anxiety/depression including 1 item each with 5 levels
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Change from baseline to 12 months
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Health status
Time Frame: Change from baseline to 12 months
|
Visual analogue scale "Feeling thermometer" (0-100 scale; 0= "worst health you can imagine"; 100="best health you can imagine")
|
Change from baseline to 12 months
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Exacerbations
Time Frame: During entire study, assessed at 12 months
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Event based, patient reported
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During entire study, assessed at 12 months
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Symptoms
Time Frame: Change from baseline to 12 months
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Questionnaire, COPD Assessment Test
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Change from baseline to 12 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Compliance to the exercise training program
Time Frame: Assessed daily by intervention group participants during 12 months
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Percentage of fulfilled training sessions based on training diaries
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Assessed daily by intervention group participants during 12 months
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Satisfaction with the exercise training program
Time Frame: From baseline to 12 months
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Questionnaire (Likert-Type scales)
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From baseline to 12 months
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Experience with the exercise training program
Time Frame: From baseline to 12 months (assessed at 12 months)
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Semi-structured interview
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From baseline to 12 months (assessed at 12 months)
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Health professionals' feedback
Time Frame: Assessed at 12 months
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Semi-structured interview
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Assessed at 12 months
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Cost effectiveness
Time Frame: From baseline to 12 months (assessed at 3, 6, 12 months)
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Questionnaire: cost per quality-adjusted life year
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From baseline to 12 months (assessed at 3, 6, 12 months)
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Frei A, Radtke T, Dalla Lana K, Brun P, Sigrist T, Spielmanns M, Beyer S, Riegler TF, Busching G, Spielmanns S, Kunz R, Cerini T, Braun J, Tomonaga Y, Serra-Burriel M, Polhemus A, Puhan MA. Effectiveness of a Long-term Home-Based Exercise Training Program in Patients With COPD After Pulmonary Rehabilitation: A Multicenter Randomized Controlled Trial. Chest. 2022 Dec;162(6):1277-1286. doi: 10.1016/j.chest.2022.07.026. Epub 2022 Aug 8.
- Frei A, Radtke T, Dalla Lana K, Braun J, Muller RM, Puhan MA. Effects of a long-term home-based exercise training programme using minimal equipment vs. usual care in COPD patients: a study protocol for two multicentre randomised controlled trials (HOMEX-1 and HOMEX-2 trials). BMC Pulm Med. 2019 Mar 1;19(1):57. doi: 10.1186/s12890-019-0817-7.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HOMEX-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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