Home-based Exercise Training for COPD Patients (HOMEX-1)
Primary Purpose
Chronic Disease, Lung Diseases, Obstructive, Respiratory Disease
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Exercise
Sponsored by
About this trial
This is an interventional other trial for Chronic Disease focused on measuring exercise, minimal equipment, home-based, COPD
Eligibility Criteria
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.
Sites / Locations
- Klinik Barmelweid
- Berner Reha Zentrum AG
- Zürcher RehaZentren Wald
- Kantonsspital Winterthur
- University of Zurich
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Exercise intervention
Control
Arm Description
Home-based, minimal equipment exercise training program.
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)
Outcomes
Primary Outcome Measures
Dyspnea
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)
Secondary Outcome Measures
Dyspnea
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)
Exercise capacity
Six-Minute Walk Test (walk distance) and
1-min Sit-to-Stand Test (number of repetitions)
Health-related quality of life
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
Health status
Visual analogue scale "Feeling thermometer" (0-100 scale; 0= "worst health you can imagine"; 100="best health you can imagine")
Exacerbations
Event based, patient reported
Symptoms
Questionnaire, COPD Assessment Test
Full Information
NCT ID
NCT03461887
First Posted
February 6, 2018
Last Updated
December 23, 2021
Sponsor
University of Zurich
1. Study Identification
Unique Protocol Identification Number
NCT03461887
Brief Title
Home-based Exercise Training for COPD Patients
Acronym
HOMEX-1
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
January 24, 2018 (Actual)
Primary Completion Date
March 20, 2020 (Actual)
Study Completion Date
September 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to assess the effectiveness of a home-based exercise training program in COPD patients who have completed a pulmonary rehabilitation.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease, Lung Diseases, Obstructive, Respiratory Disease
Keywords
exercise, minimal equipment, home-based, COPD
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
123 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise intervention
Arm Type
Experimental
Arm Description
Home-based, minimal equipment exercise training program.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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)
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Dyspnea
Description
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)
Time Frame
Change from baseline to 12 months
Secondary Outcome Measure Information:
Title
Dyspnea
Description
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)
Time Frame
Change from baseline to 3, 6 and 12 months
Title
Exercise capacity
Description
Six-Minute Walk Test (walk distance) and
1-min Sit-to-Stand Test (number of repetitions)
Time Frame
Change from baseline to 12 months
Title
Health-related quality of life
Description
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
Time Frame
Change from baseline to 12 months
Title
Health status
Description
Visual analogue scale "Feeling thermometer" (0-100 scale; 0= "worst health you can imagine"; 100="best health you can imagine")
Time Frame
Change from baseline to 12 months
Title
Exacerbations
Description
Event based, patient reported
Time Frame
During entire study, assessed at 12 months
Title
Symptoms
Description
Questionnaire, COPD Assessment Test
Time Frame
Change from baseline to 12 months
Other Pre-specified Outcome Measures:
Title
Compliance to the exercise training program
Description
Percentage of fulfilled training sessions based on training diaries
Time Frame
Assessed daily by intervention group participants during 12 months
Title
Satisfaction with the exercise training program
Description
Questionnaire (Likert-Type scales)
Time Frame
From baseline to 12 months
Title
Experience with the exercise training program
Description
Semi-structured interview
Time Frame
From baseline to 12 months (assessed at 12 months)
Title
Health professionals' feedback
Description
Semi-structured interview
Time Frame
Assessed at 12 months
Title
Cost effectiveness
Description
Questionnaire: cost per quality-adjusted life year
Time Frame
From baseline to 12 months (assessed at 3, 6, 12 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Klinik Barmelweid
City
Barmelweid
ZIP/Postal Code
5017
Country
Switzerland
Facility Name
Berner Reha Zentrum AG
City
Heiligenschwendi
ZIP/Postal Code
3625
Country
Switzerland
Facility Name
Zürcher RehaZentren Wald
City
Wald
ZIP/Postal Code
8636
Country
Switzerland
Facility Name
Kantonsspital Winterthur
City
Winterthur
ZIP/Postal Code
8401
Country
Switzerland
Facility Name
University of Zurich
City
Zurich
ZIP/Postal Code
8001
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35952766
Citation
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.
Results Reference
derived
PubMed Identifier
30823913
Citation
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.
Results Reference
derived
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Home-based Exercise Training for COPD Patients
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