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

Chronic Disease Clinical Trial

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: NCT03654092
• Other study ID #: HOMEX-2
• Status: Completed
• Phase: N/A
• Start date: October 19, 2018
• Est. completion date: December 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 did not participate in an inpatient or outpatient rehabilitation program within the last 2 years.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 15, 2021
• Est. primary completion date: March 10, 2021
• 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
• 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

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	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 (self-developed questionnaire)	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)	From baseline to 12 months, assessed at 12 months
Other	Experience with the exercise training program of the participants	Semi-structured interview and/or focus groups	From baseline to 12 months, assessed at 12 months
Other	Experience with the exercise training program of the health professionals	Semi-structured interview and/or focus groups	From baseline to 12 months, assessed at 12 months
Other	Cost effectiveness	Questionnaire: Cost per quality-adjusted life-year, direct healthcare costs, direct non-healthcare costs, indirect costs	From baseline to 12 months, assessed at 3, 6 and 12 months
Primary	Dyspnea (Chronic Respiratory Questionnaire (CRQ) domain)	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 12 months
Secondary	Dyspnea (Chronic Respiratory Questionnaire (CRQ) domain)	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
Secondary	Functional exercise capacity (Six-Minute Walk Test; 6MWT)	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	Change from baseline to 12 months
Secondary	Functional exercise capacity (1-min Sit-to-Stand test; 1-min-STS test)	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	Change from baseline to 12 months
Secondary	Health-related quality of life (Chronic Respiratory Questionnaire; CRQ)	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	Change from baseline to 12 months
Secondary	Physical activity (PROactive physical activity in COPD instrument, clinical visit version; C-PPAC; domains amount and difficulty)	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)	Change from baseline to 12 months, measured during 1 week prior to the visits
Secondary	Symptoms (COPD Assessment Test; CAT)	The CAT measures the impact of COPD on a person's health status (8 questions, 6-point Likert-type scale)	Change from baseline to 12 months
Secondary	Hospital Anxiety and Depression Scale (HADS)	Symptoms of depression and anxiety (14 questions, 4-point Likert-type scale)	Change from baseline to 12 months
Secondary	Health status (Feeling Thermometer; FT)	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)	Change from baseline to 12 months
Secondary	Health-related quality of life (EuroQOL; EQ-5D-5L)	The EQ-5D-5L assesses the 5 dimensions mobility, self-care, usual activities, pain/discomfort, anxiety/depression including 1 item with 5 levels each	Change from baseline to 12 months
Secondary	Exacerbations of COPD (event based, patient reported)	The event-based definition required an increase in symptoms and an increase in dosage of or new prescription of systemic corticosteroids and/or antibiotics	During the entire study, assessed at 3, 6 and 12 months