Home-based Exercise Training for COPD Patients (HOMEX-2)

Not Applicable

Completed

• Conditions: Chronic Disease; Lung Diseases, Obstructive; Respiratory Disease
• Interventions: Behavioral: Exercise

• Registration Number: NCT03654092
• Lead Sponsor: University of Zurich

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.

Study Timeline

• Study First Submitted: 2018-07-17
• Study First Submitted QC: 2018-08-29
• Study First Posted: 2018-08-31
• Study Start: 2018-10-19
• Primary Completion: 2021-03-10
• Status Verified: 2021-12
• Study Completion: 2021-12-15
• Last Update Submitted: 2021-12-23
• Last Update Posted: 2021-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise intervention	Exercise	Home-based, minimal equipment exercise training program.

Primary Outcome Measures

Name	Time	Method
Dyspnea (Chronic Respiratory Questionnaire (CRQ) domain)	Change from baseline to 12 months	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

Name	Time	Method
Functional exercise capacity (1-min Sit-to-Stand test; 1-min-STS test)	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
Hospital Anxiety and Depression Scale (HADS)	Change from baseline to 12 months	Symptoms of depression and anxiety (14 questions, 4-point Likert-type scale)
Symptoms (COPD Assessment Test; CAT)	Change from baseline to 12 months	The CAT measures the impact of COPD on a person's health status (8 questions, 6-point Likert-type scale)
Health status (Feeling Thermometer; FT)	Change from baseline to 12 months	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)	Change from baseline to 12 months	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)	During the entire study, assessed at 3, 6 and 12 months	The event-based definition required an increase in symptoms and an increase in dosage of or new prescription of systemic corticosteroids and/or antibiotics
Dyspnea (Chronic Respiratory Questionnaire (CRQ) domain)	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)
Functional exercise capacity (Six-Minute Walk Test; 6MWT)	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
Health-related quality of life (Chronic Respiratory Questionnaire; CRQ)	Change from baseline to 12 months	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)	Change from baseline to 12 months, measured during 1 week prior to the visits	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)

Trial Locations

Locations (1)

University of Zurich; 🇨🇭 Zurich, Switzerland