The aim of this randomised controlled trial is to evaluate the safety, feasibility and effect on quality of life of an exercise training program for 12 weeks in palliative care for patients with advanced cancer. This will be achieved by measuring…
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study outcome is the self-reported health-related quality of life
(HRQOL) at baseline and after 12 weeks of exercise training.
Secondary outcome
Secondary outcomes are aerobic capacity, level of fatigue, muscle strength and
mobility.
Background summary
In cancer patients receiving curative treatment, research showed an improvement
in quality of life and level of fatigue after finishing an exercise program
during and after cancer treatment. Despite these positive findings in curative
cancer patients, only a few small-scale studies have investigated the role of
an exercise program in palliative care.
Study objective
The aim of this randomised controlled trial is to evaluate the safety,
feasibility and effect on quality of life of an exercise training program for
12 weeks in palliative care for patients with advanced cancer. This will be
achieved by measuring the self-reported health-related quality of life (using
the QLQ-C30 core questionnaire version 3.0), aerobic capacity (using the steep
ramp protocol on a stationary bicycle), muscle strength (using a hand-held
dynamometer), level of fatigue (using the FACIT-F questionnaire) and mobility
(using the timed up and go test and a pedometer).
Study design
Open randomised controlled trial with interim analysis.
Intervention
12 week exercise training program consisting of a combination of strength and
endurance training. Training will be twice a week for one hour.
Study burden and risks
Previous research in curative cancer care patient showed an improvement in
quality of life and level of fatigue after finishing an exercise training
program during and after cancer treatment. In this relative well-functioning
group of palliative patients, we expect outcomes to be positive as well. This
is also seen in most small scale studies of exercise training in palliative
care. Furthermore, previous research in curative cancer patients showed that an
exercise training program is safe. However expected to be small, there may be
some minor risks by participating in this study. With every kind of exercise
there may be a risk of muscle soreness or getting injured. Overtraining and
injuries caused by a poor technique will be prevented by supervision of a
physiotherapist during training sessions. Besides, some patients will be
confront with their physical limitations by filling in the quality of life
questionnaire. However, it can be useful to confront your limitations to seek
help for it. Furthermore, we have kept the questionnaires to a minimum to avoid
participants overly reflect on their own health.
Burgemeester Banninglaan 1
Leidschendam 2262 BA
NL
Burgemeester Banninglaan 1
Leidschendam 2262 BA
NL
Listed location countries
Age
Inclusion criteria
1) Patients aged * 18 with all types of cancer without options for curative treatment and a life-expectancy of one to five years.
2) Karnofsky performance score * 80
Exclusion criteria
1) Concurrent medical conditions
2) Inability to walk without walking aids in the home situation
3) Inability to understand the Dutch language.
4) Participation in other exercise training programs.
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 | NL56748.098.16 |