Home-based Exercise Training for COPD Patients

Chronic Disease Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03461887
• Other study ID #: HOMEX-1
• Status: Completed
• Phase: N/A
• Start date: January 24, 2018
• Est. completion date: September 15, 2021

Study information

• Verified date: December 2021
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: September 15, 2021
• Est. primary completion date: March 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Respiration Disorders
• Respiratory Disease
• Respiratory Tract Diseases

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Klinik Barmelweid	Barmelweid
Switzerland	Berner Reha Zentrum AG	Heiligenschwendi
Switzerland	Zürcher RehaZentren Wald	Wald
Switzerland	Kantonsspital Winterthur	Winterthur
Switzerland	University of Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Compliance to the exercise training program	Percentage of fulfilled training sessions based on training diaries	Assessed daily by intervention group participants during 12 months
Other	Satisfaction with the exercise training program	Questionnaire (Likert-Type scales)	From baseline to 12 months
Other	Experience with the exercise training program	Semi-structured interview	From baseline to 12 months (assessed at 12 months)
Other	Health professionals' feedback	Semi-structured interview	Assessed at 12 months
Other	Cost effectiveness	Questionnaire: cost per quality-adjusted life year	From baseline to 12 months (assessed at 3, 6, 12 months)
Primary	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)	Change from baseline to 12 months
Secondary	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)	Change from baseline to 3, 6 and 12 months
Secondary	Exercise capacity	Six-Minute Walk Test (walk distance) and; 1-min Sit-to-Stand Test (number of repetitions)	Change from baseline to 12 months
Secondary	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	Change from baseline to 12 months
Secondary	Health status	Visual analogue scale "Feeling thermometer" (0-100 scale; 0= "worst health you can imagine"; 100="best health you can imagine")	Change from baseline to 12 months
Secondary	Exacerbations	Event based, patient reported	During entire study, assessed at 12 months
Secondary	Symptoms	Questionnaire, COPD Assessment Test	Change from baseline to 12 months