A randomized controlled trial to evaluate the effectiveness and cost-effectiveness of exercise interventions after chemotherapy on physical fitness, fatigue and quality of life.

Cancer chemotherapy is frequently associated with a decline in general physical
fitness and severe symptoms of fatigue. While accumulating evidence suggests
that physical activity and exercise interventions after chemotherapy may
contribute to preservation of physical fitness and reduction of fatigue.
However, evidence-based recommendations regarding the optimal training approach
and training intensity in cancer patients are still lacking.

This present study aims to investigate the effectiveness and cost-effectiveness
of a high intensity exercise program, a low-to-moderate intensity exercise
program and a waiting list control group on physical fitness (cardiorespiratory
fitness and muscle strength) and fatigue in cancer patients who completed
chemotherapy.

This multicenter, prospective, randomized trial will compare two exercise
programs and a waiting list contole group.

A. High intensity exercise program

Patients allocated to the high intensity exercise program will train in groups
twice a week for 12 weeks under supervision of a physiotherapist. One training
session takes one hour. The high intensity exercise program includes high
intensity endurance and resistance exercises. In addition, daily physical
activity is stimulated using behavioural motivational techniques.



B. Low-to-moderate intensity exercise program

Patients allocated to the low-to-moderate intensity exercise program will train
in groups twice a week, for 12 weeks under supervision of a physiotherapist as
well. One training session takes one hour. The low-to-moderate exercise program
includes the same endurance and resistance exercises compared to the high
intensity exercise program, but differs in training intensity. In addition,
daily physical activity is stimulated using behavioural motivational
techniques.

In total, 280 consenting patients will be randomly assigned to either a 12-week
high intensity exercise program or a low-to-moderate intensity exercise
program. Next, patients from both groups will be randomly assigned to immediate
training or waiting list (i.e. waiting list control group). After 12 weeks,
patients of the waiting list control group will start with the exercise program
they have been allocated to.

Both exercise programs, the high intensity exercise program and the
low-to-moderate intensity exercise program, consist of 12 weeks of training,
twice a week (24 h.). Furthermore behavioural motivational counselling sessions
(3 h.) will be provided during and after the exercise programs to stimulate
daily physical activity.

All patients participating in the randomized trial will be asked 3 times to
undergo a physical fitness examination (1.15 h.) and to complete self-report
questionnaires (60 min.), 4-6 weeks after chemotherapy, after completion of the
exercise program and after 12 months follow-up. In addition, all patients will
be invited for a DXA scan two times (30 min.) and will be asked to complete a
cost diary every three months (30 min.).

Relevance: If demonstrated to be effective, the availability of such exercise
intervention programs will be a welcome addition to the standard program of
care offered to cancer patients after chemotherapy treatment.