To evaluate the safety, feasibility and efficacy of an 8-week remotely supervised home-based maintenance exercise training program following pulmonary rehabilitation in patients with COPD.
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Feasibility will be assessed by the adherence to home-based maintenance
exercise training sessions (i.e. the number of completed training sessions
uploaded in the web-portal and training variables of these sessions (duration,
intensity)).
- Safety will be assessed by the number of (S)AEs.
- Efficacy will be assessed by the change in exercise capacity on constant work
rate cycle test (endurance time, Borg scores for dyspnea and fatigue).
Secondary outcome
- To explore changes in functional exercise capacity assessed on 6 minute walk
test.
- To explore changes on patient-reported outcomes using COPD Assessment Test
and Hospital Anxiety and Depression Scale.
- To explore differences in physical activity between exercise and non-exercise
days, assessed using an accelerometer (ActiGraph GT9X Link, Pensacola, FL, USA).
- To explore patient satisfaction using a structured interview and the Quebec
User Evaluation of Satisfaction with Assistive Technology (QUEST).
Background summary
There is strong evidence supporting the benefits of pulmonary rehabilitation
for people with COPD, though exercise capacity and health-related quality of
life diminish in the 12 months after program completion. Therefore, there is
growing interest in the role of maintenance programs. Remotely supervised
maintenance strategies are emerging in patients with COPD, however, the
effectiveness of these remote home-based maintenance programs are still
unclear.
Study objective
To evaluate the safety, feasibility and efficacy of an 8-week remotely
supervised home-based maintenance exercise training program following pulmonary
rehabilitation in patients with COPD.
Study design
Prospective observational pilot study
Study burden and risks
There is very low risk associated with participation in this study, since no
invasive procedures will be performed. The burden of the study is mainly the
investment of the patients' time. Patients will have to perform an 8-week
home-based maintenance exercise training program and an extra visit to Ciro to
perform an six-minute walk test and constant work rate cycle test. However,
this time investment is expected to have beneficial effects in terms of
improved exercise capacity and quality of life for the patients and therefore
we consider the burden proportional.
Hornerheide 1
Horn 6085 NM
NL
Hornerheide 1
Horn 6085 NM
NL
Listed location countries
Age
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).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL81964.100.22 |