HOMEX-1: Home-based Exercise Training for COPD Patients

Sponsor

University of Zurich (Other)

Overall Status

Completed

CT.gov ID

NCT03461887

Collaborator

(none)

123

Enrollment

Locations

Arms

43.7

Actual Duration (Months)

24.6

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Disease Lung Diseases, Obstructive Respiratory Disease	Behavioral: Exercise	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

123 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

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

Actual Study Start Date :

Jan 24, 2018

Actual Primary Completion Date :

Mar 20, 2020

Actual Study Completion Date :

Sep 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Exercise intervention Home-based, minimal equipment exercise training program.	Behavioral: Exercise 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.
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)

Arm

Intervention/Treatment

Experimental: Exercise intervention

Home-based, minimal equipment exercise training program.

Behavioral: Exercise

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.

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)

Outcome Measures

Primary Outcome Measures

Dyspnea [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)

Secondary Outcome Measures

Dyspnea [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)
Exercise capacity [Change from baseline to 12 months]
Six-Minute Walk Test (walk distance) and 1-min Sit-to-Stand Test (number of repetitions)
Health-related quality of life [Change from baseline to 12 months]
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 [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")
Exacerbations [During entire study, assessed at 12 months]
Event based, patient reported
Symptoms [Change from baseline to 12 months]
Questionnaire, COPD Assessment Test

Other Outcome Measures

Compliance to the exercise training program [Assessed daily by intervention group participants during 12 months]
Percentage of fulfilled training sessions based on training diaries
Satisfaction with the exercise training program [From baseline to 12 months]
Questionnaire (Likert-Type scales)
Experience with the exercise training program [From baseline to 12 months (assessed at 12 months)]
Semi-structured interview
Health professionals' feedback [Assessed at 12 months]
Semi-structured interview
Cost effectiveness [From baseline to 12 months (assessed at 3, 6, 12 months)]
Questionnaire: cost per quality-adjusted life year

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Klinik Barmelweid	Barmelweid	Switzerland	5017
2	Berner Reha Zentrum AG	Heiligenschwendi	Switzerland	3625
3	Zürcher RehaZentren Wald	Wald	Switzerland	8636
4	Kantonsspital Winterthur	Winterthur	Switzerland	8401
5	University of Zurich	Zurich	Switzerland	8001