Back to resultsHome-based Exercise Training for COPD Patients (HOMEX-2)
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, Exercise training intervention, Randomized controlled trial
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
- No participation in an inpatient or outpatient pulmonary rehabilitation within the last 12 months
- 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.
- Planned participation in a pulmonary rehabilitation program
Sites / Locations
- 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 decisions, including participation in other exercise training programs).
Outcomes
Primary Outcome Measures
Dyspnea (Chronic Respiratory Questionnaire (CRQ) domain)
Dyspnea domain of the CRQ; 5 questions; 7-point Likert-type scale ranging from 1 (most severe dyspnea) to 7 (no dyspnea)
Secondary Outcome Measures
Dyspnea (Chronic Respiratory Questionnaire (CRQ) domain)
Dyspnea domain of the CRQ; 5 questions; 7-point Likert-type scale ranging from 1 (most severe dyspnea) to 7 (no dyspnea)
Functional exercise capacity (Six-Minute Walk Test; 6MWT)
Total distance in meters walked by the patient during timed six minutes. The 6MWT will be conducted twice (the better result will be used) and according to the American Thoracic Society (ATS) guidelines
Functional exercise capacity (1-min Sit-to-Stand test; 1-min-STS test)
The number of repetitions that the patient completes the full sit-to-stand movement from a standard chair (i.e. standing up from a chair and sitting down again) during one minute
Health-related quality of life (Chronic Respiratory Questionnaire; CRQ)
Remaining domains of the CRQ (besides the dyspnea domain): Domains fatigue, emotional function and mastery. The total CRQ contains 20 questions responded to on a 7-point Likert-type scale, ranging from 1 to 7 with lower scores indicating worse HRQoL, loading on the domains dyspnea, fatigue, emotional and mastery
Physical activity (PROactive physical activity in COPD instrument, clinical visit version; C-PPAC; domains amount and difficulty)
The C-PPAC is a validated and reliable hybrid tool combining a short patient-reported outcome questionnaire and two activity monitor variables (assessed by the accelerometer ActiGraph®) to measure physical activity in COPD patients in the two domains amount and difficulty (item scores 0-4, scale 0-100)
Symptoms (COPD Assessment Test; CAT)
The CAT measures the impact of COPD on a person's health status (8 questions, 6-point Likert-type scale)
Hospital Anxiety and Depression Scale (HADS)
Symptoms of depression and anxiety (14 questions, 4-point Likert-type scale)
Health status (Feeling Thermometer; FT)
The FT is a visual analogue scale for overall health state ranging from 0 (worst health you can imagine) to 100 (best healthy you can imagine)
Health-related quality of life (EuroQOL; EQ-5D-5L)
The EQ-5D-5L assesses the 5 dimensions mobility, self-care, usual activities, pain/discomfort, anxiety/depression including 1 item with 5 levels each
Exacerbations of COPD (event based, patient reported)
The event-based definition required an increase in symptoms and an increase in dosage of or new prescription of systemic corticosteroids and/or antibiotics
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03654092
Brief Title
Home-based Exercise Training for COPD Patients (HOMEX-2)
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
October 19, 2018 (Actual)
Primary Completion Date
March 10, 2021 (Actual)
Study Completion Date
December 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 did not participate in an inpatient or outpatient rehabilitation program within the last 2 years.
Detailed Description
Exercise training is an important component of pulmonary rehabilitation (PR) 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 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 PR.
This study evaluates a newly developed 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, Exercise training intervention, Randomized controlled trial
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (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 decisions, including participation in other exercise training 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 (Chronic Respiratory Questionnaire (CRQ) domain)
Description
Dyspnea domain of the 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 (Chronic Respiratory Questionnaire (CRQ) domain)
Description
Dyspnea domain of the 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
Functional exercise capacity (Six-Minute Walk Test; 6MWT)
Description
Total distance in meters walked by the patient during timed six minutes. The 6MWT will be conducted twice (the better result will be used) and according to the American Thoracic Society (ATS) guidelines
Time Frame
Change from baseline to 12 months
Title
Functional exercise capacity (1-min Sit-to-Stand test; 1-min-STS test)
Description
The number of repetitions that the patient completes the full sit-to-stand movement from a standard chair (i.e. standing up from a chair and sitting down again) during one minute
Time Frame
Change from baseline to 12 months
Title
Health-related quality of life (Chronic Respiratory Questionnaire; CRQ)
Description
Remaining domains of the CRQ (besides the dyspnea domain): Domains fatigue, emotional function and mastery. The total CRQ contains 20 questions responded to on a 7-point Likert-type scale, ranging from 1 to 7 with lower scores indicating worse HRQoL, loading on the domains dyspnea, fatigue, emotional and mastery
Time Frame
Change from baseline to 12 months
Title
Physical activity (PROactive physical activity in COPD instrument, clinical visit version; C-PPAC; domains amount and difficulty)
Description
The C-PPAC is a validated and reliable hybrid tool combining a short patient-reported outcome questionnaire and two activity monitor variables (assessed by the accelerometer ActiGraph®) to measure physical activity in COPD patients in the two domains amount and difficulty (item scores 0-4, scale 0-100)
Time Frame
Change from baseline to 12 months, measured during 1 week prior to the visits
Title
Symptoms (COPD Assessment Test; CAT)
Description
The CAT measures the impact of COPD on a person's health status (8 questions, 6-point Likert-type scale)
Time Frame
Change from baseline to 12 months
Title
Hospital Anxiety and Depression Scale (HADS)
Description
Symptoms of depression and anxiety (14 questions, 4-point Likert-type scale)
Time Frame
Change from baseline to 12 months
Title
Health status (Feeling Thermometer; FT)
Description
The FT is a visual analogue scale for overall health state ranging from 0 (worst health you can imagine) to 100 (best healthy you can imagine)
Time Frame
Change from baseline to 12 months
Title
Health-related quality of life (EuroQOL; EQ-5D-5L)
Description
The EQ-5D-5L assesses the 5 dimensions mobility, self-care, usual activities, pain/discomfort, anxiety/depression including 1 item with 5 levels each
Time Frame
Change from baseline to 12 months
Title
Exacerbations of COPD (event based, patient reported)
Description
The event-based definition required an increase in symptoms and an increase in dosage of or new prescription of systemic corticosteroids and/or antibiotics
Time Frame
During the entire study, assessed at 3, 6 and 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 (self-developed questionnaire)
Description
Self-developed questionnaire assessing satisfaction with the intervention: 10 specific questions regarding elements of the intervention using Likert-type scales from 0=not useful at all to 10=very useful) and 4 global questions using Likert-type scales (from 0=worst outcome to 4=best outcome)
Time Frame
From baseline to 12 months, assessed at 12 months
Title
Experience with the exercise training program of the participants
Description
Semi-structured interview and/or focus groups
Time Frame
From baseline to 12 months, assessed at 12 months
Title
Experience with the exercise training program of the health professionals
Description
Semi-structured interview and/or focus groups
Time Frame
From baseline to 12 months, assessed at 12 months
Title
Cost effectiveness
Description
Questionnaire: Cost per quality-adjusted life-year, direct healthcare costs, direct non-healthcare costs, indirect costs
Time Frame
From baseline to 12 months, assessed at 3, 6 and 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
No participation in an inpatient or outpatient pulmonary rehabilitation within the last 12 months
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.
Planned participation in a pulmonary rehabilitation program
Facility Information:
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
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
Learn more about this trial
Home-based Exercise Training for COPD Patients (HOMEX-2)
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