This pilot study focuses mainly on the feasibility and safety of the study (inclusion, randomization, testing procedure, evaluation of the training).The main objective of the intended study is to investigate whether a 12-week, group wise supervised…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
oncologische aandoeningen in palliatief behandelstadium
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameter is:
- Feasibility of the study
Secondary outcome
Secondary study parameters are:
- Quality of life (EORTC QLQ C30).
- Physical fitness (six minute walk and muscle strength)
- Fatigue (MFI-20).
Background summary
A lot of evidence is generated for training interventions before, during, and
after cancer treatment (Galvao, 2005; Knols, 2005; De Backer, 2008; Van Weert,
2006; Adamsen, 2006; Young, 2003) but maintenance and recovery of physical
functioning has received relatively little attention in palliative care
research and in clinical practice. Only a few centers offer physical training
for advanced cancer patients and studies concerning physical training for
advanced cancer patients are poor and lacking quality (Lowe, 2009). This is in
contrast to patients* priorities. Physical functioning, physical condition and
fatigue are among the most important determinants of palliative patients*
quality of life (Cohen, 2002). The majority of cancer patients express a wish
to remain physically independent as long as possible and want to maintain
strength and endurance throughout the course of their disease (Oldervoll, 2006;
Clark, 2007).
Study objective
This pilot study focuses mainly on the feasibility and safety of the study
(inclusion, randomization, testing procedure, evaluation of the training).
The main objective of the intended study is to investigate whether a 12-week,
group wise supervised, personalized physical training program for advanced
cancer patients improves physical fitness and physical performance, reduces
complaints of fatigue and improves health related quality of life.
Study design
It concerns a randomized, single blinded, controlled pilot study of one year.
The intervention will be carried out in the University Medical Center Utrecht
at the department of Rehabilitation, Nursing Science & Sports.
Intervention
The intervention group receives a training program, twice a week, during 12
weeks. This program will be personalized to the patient*s abilities and
preferences. Total length will be 60 minutes and includes a warming-up (10
minutes), a personalized training program with both aerobic and muscle strength
training (40 minutes, emphasis on muscle strength training) and a cooling down
(10 minutes). The control group receives usual care.
Study burden and risks
Patients included in the study will be asked to visit the University Medical
Center Utrecht three times to complete questionnaires and to perform several
physical tests.
Testing and training will take place under supervision of experienced staff and
a medical specialist will be available in case of emergencies. Patients
allocated to the intervention group are supposed to participate in a 12-week
group wise supervised physical training program, twice a week. The estimated
extra risk for the patient while participating in this study is low. However,
exercise related injuries can occur. We expect the physical training program to
be effective on the patients* health status (decrease fatigue, improve physical
fitness and therefore improve quality of life).
Heidelberglaan 100
3584 CX Utrecht
NL
Heidelberglaan 100
3584 CX Utrecht
NL
Listed location countries
Age
Inclusion criteria
- Functional Status: WHO-score 0 up to 2
- Incurable form of cancer (patients are allowed to receive palliative treatment)
- Treated within the Department of Medical Oncology, UMC Utrecht or receiving daycare from hospice Demeter
- Prognosis of more than six months
- Able to read and understand the Dutch language
- Not reporting contra indications for physical activity
Exclusion criteria
- Participatie in a phase 1 study
- No informed consent
- Patients with an increased risk of pathological fractures
- Patients with central neurological problems
- Not able to perform the physical tests, or visit the training twice a week
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 | NL32042.041.10 |