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Completed

NCT Number: NCT03654092

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

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.

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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

University of Zurich

Zurich, 8001, Switzerland

About this study

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.

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
  • 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

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 (Chronic Respiratory Questionnaire (CRQ) domain)

    Time frame: 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 outcomes

  1. Dyspnea (Chronic Respiratory Questionnaire (CRQ) domain)

    Time frame: 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)

  2. Functional exercise capacity (Six-Minute Walk Test; 6MWT)

    Time frame: 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

  3. Functional exercise capacity (1-min Sit-to-Stand test; 1-min-STS test)

    Time frame: 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

  4. Health-related quality of life (Chronic Respiratory Questionnaire; CRQ)

    Time frame: 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

  5. Physical activity (PROactive physical activity in COPD instrument, clinical visit version; C-PPAC; domains amount and difficulty)

    Time frame: 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)

  6. Symptoms (COPD Assessment Test; CAT)

    Time frame: 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)

  7. Hospital Anxiety and Depression Scale (HADS)

    Time frame: Change from baseline to 12 months

    Symptoms of depression and anxiety (14 questions, 4-point Likert-type scale)

  8. Health status (Feeling Thermometer; FT)

    Time frame: 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)

  9. Health-related quality of life (EuroQOL; EQ-5D-5L)

    Time frame: 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

  10. Exacerbations of COPD (event based, patient reported)

    Time frame: 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 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 (self-developed questionnaire)

    Time frame: 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)

  3. Experience with the exercise training program of the participants

    Time frame: From baseline to 12 months, assessed at 12 months

    Semi-structured interview and/or focus groups

  4. Experience with the exercise training program of the health professionals

    Time frame: From baseline to 12 months, assessed at 12 months

    Semi-structured interview and/or focus groups

  5. Cost effectiveness

    Time frame: 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

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Aug 31, 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.

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