Skip to main content
OpenTrials
Completed

NCT Number: NCT03461887

Home-based Exercise Training for COPD Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Disease Behavior Disease Attributes Lung Diseases Lung Diseases, Obstructive Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Disease Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinik Barmelweid, Barmelweid, Switzerland

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise

Behavioral

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.

Primary outcomes

  1. Dyspnea

    Time frame: 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 outcomes

  1. Dyspnea

    Time frame: 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)

  2. Exercise capacity

    Time frame: Change from baseline to 12 months

    Six-Minute Walk Test (walk distance) and

    1-min Sit-to-Stand Test (number of repetitions)

  3. Health-related quality of life

    Time frame: 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

  4. Health status

    Time frame: 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")

  5. Exacerbations

    Time frame: During entire study, assessed at 12 months

    Event based, patient reported

  6. Symptoms

    Time frame: Change from baseline to 12 months

    Questionnaire, COPD Assessment Test

Other outcomes

  1. Compliance to the exercise training program

    Time frame: Assessed daily by intervention group participants during 12 months

    Percentage of fulfilled training sessions based on training diaries

  2. Satisfaction with the exercise training program

    Time frame: From baseline to 12 months

    Questionnaire (Likert-Type scales)

  3. Experience with the exercise training program

    Time frame: From baseline to 12 months (assessed at 12 months)

    Semi-structured interview

  4. Health professionals' feedback

    Time frame: Assessed at 12 months

    Semi-structured interview

  5. Cost effectiveness

    Time frame: From baseline to 12 months (assessed at 3, 6, 12 months)

    Questionnaire: cost per quality-adjusted life year

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study 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

Acronym: HOMEX-1

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Mar 12, 2018
Registry last updated
Dec 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.