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

Sponsor

University of Zurich (Other)

Overall Status

Completed

CT.gov ID

NCT03654092

Collaborator

(none)

Enrollment

Location

Arms

37.9

Actual Duration (Months)

1.3

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 did not participate in an inpatient or outpatient rehabilitation program within the last 2 years.

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 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 Design

Study Type:

Interventional

Actual Enrollment :

50 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 :

Oct 19, 2018

Actual Primary Completion Date :

Mar 10, 2021

Actual Study Completion Date :

Dec 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 decisions, including participation in other exercise training 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 decisions, including participation in other exercise training programs).

Outcome Measures

Primary Outcome Measures

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

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
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
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)
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)
Hospital Anxiety and Depression Scale (HADS) [Change from baseline to 12 months]
Symptoms of depression and anxiety (14 questions, 4-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

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 (self-developed questionnaire) [From baseline to 12 months, assessed at 12 months]
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)
Experience with the exercise training program of the participants [From baseline to 12 months, assessed at 12 months]
Semi-structured interview and/or focus groups
Experience with the exercise training program of the health professionals [From baseline to 12 months, assessed at 12 months]
Semi-structured interview and/or focus groups
Cost effectiveness [From baseline to 12 months, assessed at 3, 6 and 12 months]
Questionnaire: Cost per quality-adjusted life-year, direct healthcare costs, direct non-healthcare costs, indirect costs

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
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