A non randomised open pilot study in palliative care: investigating the feasibility and preliminary effectiveness of an exercise program in palliative cancer patients

Often, cancer patients suffer from severe symptoms as fatigue, decreased muscle
strength and physical fitness, which results in a decreased level of physical
activity. This can have a major impact on the patients Activities of Daily
Living (ADL) and participation in social life. Also, the decreased level of
physical activity maintains the decreased level of physical fitness, so
patients are in a negative vicious circle. For curative cancer patients there
is scientific evidence that exercise can have a positive impact on these
symptoms and can break this negative vicious circle. Studies specifically
dealing with physical exercise among palliative patients or non-curative
treated patients with persistence cancer and/or metastasis and/or relapse are
few and have methodological limitations, so scientific evidence for physical
exercise in this population is poor. Although these studies show promising
results that exercise, aerobic as well as resistance training, may serve as
additional palliative treatment to improve well-being and physical capacity.
Yet more trials are needed to confirm these results.

The aim of this study is to determine the feasibility and preliminary
effectiveness of an exercise program in cancer patients with metastasis and/or
relapse, and to explore other limitations than physical fitness and their
effect on physical functioning.

A non randomised open pilot study.

All the included subjects will receive a six weeks during physical exercise
program. This program consist of aerobic exercise combined with resistance
exercise in one training session. Subjects will receive two training sessions a
week for two hours in groups of 3-5 persons. Training sessions will be
supervised by a physical therapist. Subjects are also advised to exercise
aerobically independent on the non-trainings days following the graded activity
principle.
The trainingsprogram will be adjusted to the subjects individual physical
fitness following the graded activity principle. Graded activity comprises that
the focus in the trainingsprogram will be on succes experiences and that
negative experiences are avoided as much as possible. Goals will be set in a
specific timeline, two individual goals by the subject and two general goals by
the supervising physical therapist. Baseline training will be set on a
non-threatening level for the subject. Training intensity will be gradually
build up during the training program. This will be achieved by scoring the
subjective training intensity of the subject at the end of each training with
the Borg-scale, on which the following training will be adjusted. Restperiods
will be gradually declined during the training program adjusted to the recovery
of the subject.

Each training session comprises:
- warming-up (10 min.)
- aerobic training (30 min.)
- circuit training with resistance exercise (25 min.)
- cooling-down (10 min.).
Warming-up comprises aerobic exercises executed in standing or seated position.
Aerobic exercise comprises bicycling on a hometrainer, if this is not possible
walking on a treadmill is also allowed. Intensity is set on >= 60% HRmax. Arobic
exercise will comprise interval training of 4x4 minutes on 80-90% of HRpeak
alternate with 3 minutes of activie rest on 50-70% of HRpeak. Also there is a
warming-up in the aerobic training of 10 minutes and a cooling-down of 5
minutes, both executed on 60-70% of HRpeak. Resistance exercise will be
executed in 3 series of 8-10 exercises with 8-12 repetitions on 60-80% of 1
repetition maximum (1RM). This training aims on the greater muscle groups which
are important in ADL-activities, like the shoulder, arm, back, hip and leg
muscles. Every station of resistance exercise has possibilities for individual
adjustments.

Burden:
When the subject is informed and accepts inclusion, a intake will follow with
the physical therapist. De physical therapist will perform a medical history
and a physical examination with additional (physical) tests (anthropometric
measures, 6 min. walking test and muscle force measures with HHD and HGD).
Subjects will be asked to fill in questionnaires (RAND-36, EORTC QLQ-C30, ESAS,
CIS, HADS and Last-meter) and a Physical Activity Diary (PAD, one a day), where
they also score the intensity of the physical activities with a Borg-scale and
pain (NRS).
In week 3 and 6 these measuremnets will be repeated. The questionnaires will be
filled in by the subjects and the physical therapist will repeat the physical
measurements. Anthropometric measurements and medical history will only be
repeated in week 6.

Risks:
The study design is chosen with hardly any risks for the subjects. During the
training sessions adequate safety measures are build in, like monitoring the
Heart Rate and exercises in small groups of 3-5 persons so there is sufficient
individual supervision. Also, the intervention is adjusted to the subjects
individual physical fitness level following the graded activity principle, whit
that the frail population is taken into account. Subjects having clinical
relevant comorbidity are excluded from the study.