(1) To evaluate the effectiveness of an individualized exercise program in comparison to standard care with respect to fatigue, physical fitness and health-related quality of life in patients with hematologic malignancies who have undergone HDC and…
ID
Source
Brief title
Condition
- Lymphomas Hodgkin's disease
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
primary outcome variables are fatigue, cardiorespiratory fitness and muscle
strength.
Secondary outcome
Secondary outcome variables include body composition and bone mineral density,
health-related quality of life, physical activity level, satisfaction with the
intervention, mood disturbances, functioning in daily life and return to work.
Background summary
The use of high-dose chemotherapy (HDC) and autologous stem cell
transplantation (SCT) has improved the outcome of hematologic malignancies such
as multiple myeloma and (non-) Hodgkin*s lymphoma. However, the long term side
effects of this treatment can have a strong negative impact on quality of life.
Patients often complain of severe and persistent fatigue and are compromised in
their ability to perform normal physical activities. Physical exercise
interventions after SCT can have positive effects on physical fitness, quality
of life and fatigue. However, the trials conducted so far were of poor to
moderate quality, with methological shortcomings related to trial design,
sample size, choice of comparison groups, outcome measures and duration of
follow up. There is a need for a rigorous, appropriately controlled assessment
of the effectiveness and cost-effectiveness of exercise in these patients.
Study objective
(1) To evaluate the effectiveness of an individualized exercise program in
comparison to standard care with respect to fatigue, physical fitness and
health-related quality of life in patients with hematologic malignancies who
have undergone HDC and autologous SCT. (2) To evaluate the cost-effectiveness
of this exercise program.
Study design
Following a small pilot study to evaluate feasibility of the process of
training and assessments, a prospective, randomized controlled trial will be
performed in 120 patients with multiple myeloma or relapsed (non)Hodgkin*s
lymphoma who have undergone induction chemotherapy followed by high-dose
chemotherapy and autologous SCT. Patients will be randomized to either the
intervention group or the control group. The intervention will start 6-12 weeks
after SCT and will consist of an 18-week supervised high-intensity exercise
program (2x/wk aerobic and resistance exercise). 3 booster sessions at
increasing intervals (4, 10 and 18 weeks after completion of the intervention
program) will be held during which patients are trained and counseled and
motivated to continue exercising and maintaining an active lifestyle in
general. The control group will receive the usual care. Patients will be
followed until 12 months after the end of the intervention program or a
comparable time after SCT in the control group.
Intervention
The intervention will start 6-12 weeks after SCT and will consist of an 18-week
supervised high-intensity exercise program (2x/wk aerobic and resistance
exercise). 3 booster sessions at increasing intervals (4, 10 and 18 weeks after
completion of the intervention program) will be held during which patients are
trained and counseled and motivated to continue exercising and maintaining an
active lifestyle in general.
Study burden and risks
Burden
All patients participating in the randomized trial will be asked to visit the
Academic Medical Centre at 3 times over the study period of 70 weeks to
participate in physical fitness examinations. In addition, at baseline and at
12 months follow-up all patients get a DXA scan.
The duration of the physical fitness examinitation will be approximately 1:10
hours. The duration of the DXA scan lies between 15 and 30 minutes.
Furthermore an intake (45 min) will take place at first measurement point. 10
min blood withdrawal. Additionally, at the 3 different time points
measurements patients will be asked to wear an accelerometer for 5 consecutive
days and fill out questionnaires. The duration for completing the
questionnaires is approximately 1 hour. Patients will receive cost diaries
which they will send back once a month, this will take about 15 minutes each
month. In total, the time cost for examinations will be 12:15 hours. The
intervention group will spend an other 34:05 hours on training, counseling and
the satisfaction questionnare.
There are no costs related to the interventions for the patients. All travel
expense will be compensate.
Risks
Possible medical risks related to the physical fitness tests are considered
minimal and the examinations will be done under supervision of a physician. The
DXA-scan is a safe and painless examination. The radiation dose of the DXA-scan
is minimal. All participating physical therapists are well experienced in
providing exercise therapy in patients with cancer. The exercise program is
suited to the patient and the risk are considered minimal.
Meibergdreef 9
1105 AZ
NL
Meibergdreef 9
1105 AZ
NL
Listed location countries
Age
Inclusion criteria
-diagnosed with multiple myeloma in first line or or with HL/NHL in first line or first relapse, who have undergone HDC and autologous SCT 6 to 12 weeks ago or who where recently (< 8 months) treated with HDC and autologous SCT and who have completed radiotherapy or their last cycle of consolidation chemotherapy 2 to 6 weeks ago-Sufficiently recovered from the SCT and having peripheral blood recovery;
-Age between 18 and 65 years;
-Ability to cycle on a bicycle ergometer against a load of at least 25 Watt;
-Ability to walk at least 100 meters independently without crutches/cains or walking frame;
-Written informed consent.
Exclusion criteria
-tandem autologous-allogeneic stem cell transplantation
-Severe cognitive impairment;
-Severe emotional instability;
-Insufficient mastery of the Dutch language;
-Presence of extensive osteolytic lesions with risk of fracture;
-Serious cardiopulmonary and cardiovascular conditions;
-Other disabling comorbidity interfering with the intervention program or influencing outcome parameters (a.o. having a pacemaker , epileptic seizures and poorly regulated diabetes mellitus);
-Severe infections;
-Relapse/progression of disease.
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 |
|---|---|
| Other | clinicaltrials.gov |
| CCMO | NL32139.018.10 |