The feasibility of a home-based remotely supervised maintenance exercise training program in patients with COPD

Recruiting

Conditions: Chronic bronchitis
pulmonary emphysema
10006436

Registration Number: NL-OMON51560

Lead Sponsor: Ciro

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

- Confirmed diagnoses of COPD.
- Clinical stable as assessed by the chest physician.
- Participation in cycle training during pulmonary rehabilitation.
- No balance problems as assessed by the Tinetti test during the intake with
the physiotherapist in the routine baseline assessment (score >= 24).
- Internet (Wi-Fi) access at home.
- Provision of informed consent prior to any study specific procedures.
- Complete data on study endpoints (i.e. constant work rate cycle test,
six-minute walk test, COPD Assessment Test, Hospital Anxiety and Depression
Scale).

Exclusion Criteria

- Lack of motivation for voluntary participation in the study.
- Insufficient ability to read, write or understand the Dutch language.
- Incapability to follow study procedures (including but not limited to
participate in the exercise training program or follow instructions of the
research team).

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Feasibility will be assessed by the adherence to home-based maintenance<br /><br>exercise training sessions (i.e. the number of completed training sessions<br /><br>uploaded in the web-portal and training variables of these sessions (duration,<br /><br>intensity)).<br /><br>- Safety will be assessed by the number of (S)AEs.<br /><br>- Efficacy will be assessed by the change in exercise capacity on constant work<br /><br>rate cycle test (endurance time, Borg scores for dyspnea and fatigue). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- To explore changes in functional exercise capacity assessed on 6 minute walk<br /><br>test.<br /><br>- To explore changes on patient-reported outcomes using COPD Assessment Test<br /><br>and Hospital Anxiety and Depression Scale.<br /><br>- To explore differences in physical activity between exercise and non-exercise<br /><br>days, assessed using an accelerometer (ActiGraph GT9X Link, Pensacola, FL, USA).<br /><br>- To explore patient satisfaction using a structured interview and the Quebec<br /><br>User Evaluation of Satisfaction with Assistive Technology (QUEST). </p><br>