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Chronic DiseaseNCT03654092

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

A study testing Exercise in people with Chronic Disease and Lung Diseases, Obstructive, run by University of Zurich at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 40 years and older
What is being tested?
Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteSwitzerland
Study dates
19 Oct 2018to 15 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • University of Zurich

    Zurich, 8001

Other trials in Switzerland

About this study

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

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.

Read the 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.

Being tested
Exercise
Keywords
Exercise, Minimal equipment, Home-based, COPD, Exercise training intervention, Randomized controlled trial
Medical subject headings
Chronic Disease, Lung Diseases, Obstructive, Respiration Disorders, Motor Activity, Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExerciseBehavioural

    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.

Study groups in NCT03654092
Study groupRoleWhat they receive
Exercise interventionExperimentalHome-based, minimal equipment exercise training program.
Receives: Behavioral: Exercise
ControlNo interventionUsual care (study participation does not have any impact on regular treatment decisions, including participation in other exercise training programs).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Change from baseline to 12 months

Secondary outcomes (10)

  1. 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)

    Measured: Change from baseline to 3, 6 and 12 months

  2. 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

    Measured: Change from baseline to 12 months

  3. 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

    Measured: Change from baseline to 12 months

  4. 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

    Measured: Change from baseline to 12 months

  5. 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)

    Measured: Change from baseline to 12 months, measured during 1 week prior to the visits

  6. 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)

    Measured: Change from baseline to 12 months

  7. Hospital Anxiety and Depression Scale (HADS)

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

    Measured: Change from baseline to 12 months

  8. 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)

    Measured: Change from baseline to 12 months

  9. 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

    Measured: Change from baseline to 12 months

  10. 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

    Measured: During the entire study, assessed at 3, 6 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2018
  2. Study start19 Oct 2018
  3. Primary completion10 Mar 2021
  4. Study completion15 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03654092
Sponsor's protocol ID
HOMEX-2
Status last verified
Dec 2021
First submitted
17 Jul 2018
Last updated
27 Dec 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Frei A, Radtke T, Dalla Lana K, Braun J, Muller RM, Puhan MA. Effects of a long-term home-based exercise training programme using minimal equipment vs. usual care in COPD patients: a study protocol for two multicentre randomised controlled trials (HOMEX-1 and HOMEX-2 trials). BMC Pulm Med. 2019 Mar 1;19(1):57. doi: 10.1186/s12890-019-0817-7.

    PubMed 30823913

Questions about this trial

What is this clinical trial studying?

A study testing Exercise in people with Chronic Disease and Lung Diseases, Obstructive, run by University of Zurich at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dyspnea (Chronic Respiratory Questionnaire (CRQ) domain) (time frame: Change from baseline to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03654092, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2021.

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