- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03654092
Home-based Exercise Training for COPD Patients (HOMEX-2)
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 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
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 decisions, including participation in other exercise training programs).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dyspnea (Chronic Respiratory Questionnaire (CRQ) domain)
Time Frame: Change from baseline to 12 months
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Dyspnea domain of the CRQ; 5 questions; 7-point Likert-type scale ranging from 1 (most severe dyspnea) to 7 (no dyspnea)
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Change from baseline to 12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dyspnea (Chronic Respiratory Questionnaire (CRQ) domain)
Time Frame: Change from baseline to 3, 6 and 12 months
|
Dyspnea domain of the 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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Functional exercise capacity (Six-Minute Walk Test; 6MWT)
Time Frame: Change from baseline to 12 months
|
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
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Change from baseline to 12 months
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Functional exercise capacity (1-min Sit-to-Stand test; 1-min-STS test)
Time Frame: Change from baseline to 12 months
|
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
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Change from baseline to 12 months
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Health-related quality of life (Chronic Respiratory Questionnaire; CRQ)
Time Frame: Change from baseline to 12 months
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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
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Change from baseline to 12 months
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Physical activity (PROactive physical activity in COPD instrument, clinical visit version; C-PPAC; domains amount and difficulty)
Time Frame: Change from baseline to 12 months, measured during 1 week prior to the visits
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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)
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Change from baseline to 12 months, measured during 1 week prior to the visits
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Symptoms (COPD Assessment Test; CAT)
Time Frame: Change from baseline to 12 months
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The CAT measures the impact of COPD on a person's health status (8 questions, 6-point Likert-type scale)
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Change from baseline to 12 months
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Hospital Anxiety and Depression Scale (HADS)
Time Frame: Change from baseline to 12 months
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Symptoms of depression and anxiety (14 questions, 4-point Likert-type scale)
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Change from baseline to 12 months
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Health status (Feeling Thermometer; FT)
Time Frame: Change from baseline to 12 months
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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)
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Change from baseline to 12 months
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Health-related quality of life (EuroQOL; EQ-5D-5L)
Time Frame: Change from baseline to 12 months
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The EQ-5D-5L assesses the 5 dimensions mobility, self-care, usual activities, pain/discomfort, anxiety/depression including 1 item with 5 levels each
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Change from baseline to 12 months
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Exacerbations of COPD (event based, patient reported)
Time Frame: During the entire study, assessed at 3, 6 and 12 months
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The event-based definition required an increase in symptoms and an increase in dosage of or new prescription of systemic corticosteroids and/or antibiotics
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During the entire study, assessed at 3, 6 and 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 (self-developed questionnaire)
Time Frame: From baseline to 12 months, assessed at 12 months
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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)
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From baseline to 12 months, assessed at 12 months
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Experience with the exercise training program of the participants
Time Frame: From baseline to 12 months, assessed at 12 months
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Semi-structured interview and/or focus groups
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From baseline to 12 months, assessed at 12 months
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Experience with the exercise training program of the health professionals
Time Frame: From baseline to 12 months, assessed at 12 months
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Semi-structured interview and/or focus groups
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From baseline to 12 months, assessed at 12 months
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Cost effectiveness
Time Frame: From baseline to 12 months, assessed at 3, 6 and 12 months
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Questionnaire: Cost per quality-adjusted life-year, direct healthcare costs, direct non-healthcare costs, indirect costs
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From baseline to 12 months, assessed at 3, 6 and 12 months
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Collaborators and Investigators
Sponsor
Publications and helpful links
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-2
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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