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Trial record 1 of 1 for:    NCT03461887
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Home-based Exercise Training for COPD Patients (HOMEX-1)

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ClinicalTrials.gov Identifier: NCT03461887
Recruitment Status : Recruiting
First Posted : March 12, 2018
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Disease Lung Diseases, Obstructive Respiratory Disease Behavioral: Exercise Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 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 : January 24, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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 or treatment decisions, including participation in other exercise training programs or rehabilitation programs)



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03461887


Locations
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Switzerland
Klinik Barmelweid Recruiting
Barmelweid, Switzerland, 5017
Contact: Thomas Sigrist, MD    +41 62 857 20 00    thomas.sigrist@barmelweid.ch   
Berner Reha Zentrum AG Recruiting
Heiligenschwendi, Switzerland, 3625
Contact: Patrick Brun, MD    +41 33 244 33 33    p.brun@rehabern.ch   
Zürcher RehaZentren Wald Recruiting
Wald, Switzerland, 8636
Contact: Marc Spielmanns, MD    +41 55 256 61 11    marc.spielmanns@zhreha.ch   
Kantonsspital Winterthur Recruiting
Winterthur, Switzerland, 8401
Contact: Swantje Beyer, MD    +41 52 266 23 33    swantje.beyer@ksw.ch   
University of Zurich Active, not recruiting
Zurich, Switzerland, 8001
Sponsors and Collaborators
University of Zurich

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT03461887    
Other Study ID Numbers: HOMEX-1
First Posted: March 12, 2018    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Zurich:
exercise
minimal equipment
home-based
COPD
Additional relevant MeSH terms:
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Lung Diseases
Respiration Disorders
Lung Diseases, Obstructive
Chronic Disease
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes