The primary objective is to determine feasibility of a home-based exercise program in a pilot study with patients with combined chronic pulmonary and cardiac disease.Secondary objectives are to evaluate patient satisfaction and changes in functional…
ID
Source
Brief title
Condition
- Heart failures
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is feasibility of a home-based exercise program (i.e. the
ability to complete the exercise program and a qualitative exploration of
barriers for adherence).
Secondary outcome
Secondary endpoints include patient satisfaction, functional capacity and
quality of life.
Background summary
Chronic cardiac and pulmonary diseases often co-exist and both diseases are
associated with high morbidity and mortality. Exercise is a proven effective
strategy in these patients to reduce the risk of rehospitalization and improve
functional capacity. However, due to breathlessness, muscle atrophy and
anxiety, patients with combined cardiac and pulmonary disease generally have
low activity levels and have low motivation to participate in centre-based
rehabilitation programs. To improve exercise behaviour in the home environment
we aim to conduct a pilot-study to evaluate the feasibility of a telemonitored
home-based exercise program.
Study objective
The primary objective is to determine feasibility of a home-based exercise
program in a pilot study with patients with combined chronic pulmonary and
cardiac disease.
Secondary objectives are to evaluate patient satisfaction and changes in
functional capacity and quality of life. Data generated from this pilot study
will be used to design a larger randomized controlled trial.
Study design
This is a prospective, non-randomized, single-center pilot study evaluating
feasibility.
Intervention
Patients included will receive a two-month home-based exercise program and are
coached by a physiotherapist and/or ergo therapist via video calls. The content
of this exercise program will be based on personal goals set at the baseline
intake.
Study burden and risks
Exercise training, both in a centre-based and a home-based setting, has been
proven to improve quality of life and functional capacity and to reduce risk of
rehospitalization in both patients with chronic heart failure and COPD. Several
studies showed that telerehabilitation can be safely performed and is not
associated with additional risks. To further minimize the risk of adverse
events, the exercise program consists of low-to-moderate intensity exercises.
Despite the potential benefits of exercise training, the training sessions and
uploading results afterwards may be experienced as a burden for patients.
De Run 4600
Veldhoven 5504 DB
NL
De Run 4600
Veldhoven 5504 DB
NL
Listed location countries
Age
Inclusion criteria
1. Patients with combined chronic pulmonary and cardiac disease already participating in remote patient care.
2. Motivated to participate in an exercise program.
3. Age * 18 years.
4. Speaking, writing and reading the Dutch language.
Exclusion criteria
1. Neurological, orthopaedic of peripheral vascular conditions preventing the patient from performing exercise.
2. Hemodynamic significant valvular disease.
3. Proven cardiac ischemia or heart rhythm disturbances at a low-intensity exercise level.
4. Already participating in the IN-TOuCH trial (telemonitoring for patients with COPD and chronic heart failure)
5. Already receiving physio- and/or occupational therapy.
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 | NL67504.015.18 |