This study will evaluate the efficacy of: a low intensity, home-based, self-management physical activity program, and a moderate intensity, structured, supervised exercise program, in maintaining or enhancing physical fitness (cardiorespiratory…
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcomes will be physical fitness as assessed with objective
performance indicators, and self-reported fatigue.
Secondary outcome
Secondary study outcomes will include self-reported physical activity and
physical functioning, mood state and HRQL. Additionally, compliance and
satisfaction with the interventions will be evaluated by self-report.
Potential moderating variables, including pre- and post-illness lifestyle, and
health- and exercise-related attitudes, beliefs and motivation, will also be
assessed.
Background summary
Cancer chemotherapy is frequently associated with a decline in general physical
condition, exercise tolerance, and muscle strength, and with an increase in
fatigue. While accumulating evidence suggests that physical activity and
exercise interventions during chemotherapy treatment may contribute to
preservation of physical fitness and strength, the results of studies conducted
to date have not been entirely consistent. Additional research is needed to
determine the optimal intensity of exercise training programs, in general, and
in particular the relative effectiveness of supervised, outpatient (clinic- or
physical therapy practice-based) versus home-based programs.
Study objective
This study will evaluate the efficacy of: a low intensity, home-based,
self-management physical activity program, and a moderate intensity,
structured, supervised exercise program, in maintaining or enhancing physical
fitness (cardiorespiratory fitness and muscle strength), in minimizing fatigue,
and in enhancing the health-related quality of life (HRQL) of patients
undergoing adjuvant chemotherapy for breast cancer or colon cancer.
Study design
This multicenter, prospective, randomized trial will compare two interventions
with usual care.
Intervention
Onco-Move is a relatively low intensity, home-based, individualized,
self-managed physical activity program based on the *Every Step Counts* program
of Mock. It uses self-management principles to maintain physical condition and
prevent fatigue. Nurses encourage patients to pursue an active lifestyle,
including walking, cycling, fitness or swimming, 30 minutes per day (at Borg
level 12-14), throughout the chemotherapy treatment. Training with weights is
not encouraged. In this program, general information (both verbal and written)
is provided about physical activity training.
OnTrack is a relatively intensive, structured, individualized and supervised
physical exercise program supervised by a physical therapist in an outpatient
or general practice setting. It comprises exercises to maintain or increase
cardiorespiratory fitness, and exercises to maintain or increase muscle
strength. The cardiorespiratory exercises are done twice a week, 30 minute per
session, with an intensity of 60% to 80% of the estimated maximal heart rate,
or a score of 12 to 14 on the Borg scale of perceived exertion. The muscle
strength program is also practiced twice a week (during the same sessions), 20
minutes per session, starting with 2 series of 15 repetitions at 50%1RM per
exercise and increasing gradually to less repetitions at higher load. The
participants are also encouraged to be physically active for at least 30
minutes per day at Borg level 12-14. The OnTrack program starts with a baseline
assessment before the first cycle of chemotherapy and continues until 3 weeks
after the last cycle of chemotherapy.
Usual care will vary according to hospital guidelines and doctors* and
patients* preferences, but will not involve routine, systematic exercises.
Study burden and risks
In total, 360 consenting patients will be randomized to one of the two
intervention groups or to a usual care control group. All patients will be
asked to undergo performance tests and to complete self-report questionnaires
prior to randomization (T0), at the completion of chemotherapy (T1), and at 6
month follow-up (T2).
Relevance: If demonstrated to be effective, the availability of such physical
activity and exercise intervention programs will be a welcome addition to the
standard program of care offered to cancer patients undergoing chemotherapy.
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Plesmanlaan 121
1066 CX Amsterdam
NL
Plesmanlaan 121
1066 CX Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Patients with histologically confirmed primary breast or primary colon cancer who are scheduled to undergo adjuvant chemotherapy with curative intent.
Exclusion criteria
Patients with comorbid conditions that would contraindicate participation in a physical activity/exercise program.
This includes patients with serious orthopedic conditions that would hamper functional recovery, and patients with serious cardiovascular or cardiopulmonary conditions (or risks) who would not be able to train at the intensity level required by the programs. Patients suffering from malnutrition as evidenced by a BMI < 18 kg/m2, unintended weight loss of more than 5% per month, or more than 10% unintended weight loss during the previous 6 month period will be considered poor candidates for physical condition training and thus will not be eligible for participation. Patients judged to have serious psychiatric or cognitive problems that would preclude them from program participation will be excluded from the study. For assessment purposes, study participants will need to have basic fluency in the Dutch language. Patients participating in concurrent studies or rehabilitation programs containing elements of physical activity or exercise will also be considered ineligible for the study.
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 | NL30093.031.09 |