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

NCT03654092 | Completed

• 1 other identifier: HOMEX-2
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Disease; Lung Diseases, Obstructive; Respiratory Disease

Keywords

Exercise; Minimal equipment; Home-based; COPD; Exercise training intervention; Randomized controlled trial

Outcome Measures

Primary Outcomes (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)

  Change from baseline to 12 months

Secondary Outcomes (10)

• Dyspnea (Chronic Respiratory Questionnaire (CRQ) domain)

  Change from baseline to 3, 6 and 12 months

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

  Change from baseline to 12 months

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

  Change from baseline to 12 months

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

  Change from baseline to 12 months

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

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

Other Outcomes (5)

• Compliance to the exercise training program

  Assessed daily by intervention group participants during 12 months

• Satisfaction with the exercise training program (self-developed questionnaire)

  From baseline to 12 months, assessed at 12 months

• Experience with the exercise training program of the participants

  From baseline to 12 months, assessed at 12 months

Study Arms (2)

Exercise intervention

EXPERIMENTAL

Home-based, minimal equipment exercise training program.

Behavioral: Exercise

Control

NO INTERVENTION

Usual care (study participation does not have any impact on regular treatment decisions, including participation in other exercise training programs).

Interventions

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.

Exercise intervention

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University of Zurich

Zurich, 8001, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 30823913 DERIVED

MeSH Terms

Conditions

Chronic Disease; Lung Diseases, Obstructive; Respiration Disorders; Motor Activity; Pulmonary Disease, Chronic Obstructive

Interventions

Exercise

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases; Respiratory Tract Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2018
• First Posted: August 31, 2018
• Study Start: October 19, 2018
• Primary Completion: March 10, 2021
• Study Completion: December 15, 2021
• Last Updated: December 27, 2021

Record last verified: 2021-12

Locations

CH (1)