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Souza CV, Miranda EC, Junior CG, Aranha FJ, Souza CA, Vigorito AC
Rev Bras Hematol Hemoter. 2012;34(5):345-51
Methods
Selection of subjects
This prospective study enrolled all consecutive patients
between 18 and 70 years oldwithmalignant hematological diseases,
who underwent autologous or allogeneic HSCT at the HSCT
unit of the Hospital das Clinicas of the Universidade Estadual de
Campinas – UNICAMP from November 2008 to November 2010.
The patients were included if they were submitted to high-dose or
reduced-dose allogeneic HSCT with HLA-identical related donors
with cells harvested from bone marrow or peripheral blood. The
conditioning regimens and prophylaxis for GVHD were selected
according to existing protocols at the University Hospital.
The exclusion criteria were previous HSCT and non-malignant,
neurologic, psychiatric and orthopedic diseases. Four patients were not
included in the study: two were diagnosed with depressive disorder,
one was submitted to lower limb amputation and one did not agree to
participate in the study.All consecutive patients who met the inclusion
criteria and that agreed to participate in this study gave their written
informed consent. The protocol was designed in accordance with the
requirements for research involving human subjects and approved by
the Institutional Review Board (protocol number 784/2008).
For cases of fever, infection, severe thrombocytopenia and
neutropenia at the time of evaluation, the tests were postponed,
when possible, until after the patient had recovered. Any conditions
that contraindicate exercise or those specified in the guidelines for
the six-minute walking test of the American Thoracic Society
(26)
were also considered for the two-minute walking test (2MWT).
Study procedure
Data collection and the evaluation of functions were performed
before HSCT (Phase 1) and after discharge on an outpatient basis
(Phase 2). Anthropometric data were collected and the body mass
index (BMI) was calculated. The instruments used in the evaluation
were: 1. the 2MWT, an evaluation of walking capacity performed on
a 20-meter indoor track to evaluate function of gait performance and
aerobic conditioning; 2. oxygen saturation (SaO
2
); 3. heart rate (HR)
assessed by a pulse oximeter; 4. the Borg Scale (BS), a 0 to 10 scale
of fatigue sensations, to assess fatigue before and after the 2MWT;
5. grip strength test (GS) for hand strength evaluation, performed
three times for each hand with small intervals between, using a hand
hydraulic dynamometer; 6. the Schober Test (ST), a flexion trunk test
to evaluate lumbar spine mobility; 7. maximum and adapted activity
score (MAS and AAS), variables of the Human Activity Profile
(HAP) questionnaire that evaluate functioning related to daily life
activities with the energy expenditure needed for each activity.
Statistical analysis
Descriptive analyses were performed for all variables. The
paired sample t-test was applied for physical and functional variables
to assure that the means represent the same group at different times.
The independent sample t-test was used to compare the type of HSCT.
P-value < 0.05 was considered significant and the SPSS (Statistical
Package of Social Sciences) version 14.0 was used for data analysis.
Results
As intention to treat, 50 patients were enrolled in the present
study. The median age was 48 (24-67) years and 29 (58%) of
the patients were female. Forty-four out of 50 (88%) patients
underwent HSCT [21 (48%) allogeneic and 23 (52%) autologous].
Six of 50 (12%) patients were not submitted to HSCT as three died
before the procedure, one refused to participate due to complete
remission before HSCT and two were excluded; one had exclusion
criteria and the other due to an unacceptable donor. Data on the
patients and HSCT characteristics are shown in Table 1.
Table 1 - Patients and transplant characteristics (n = 50)
Variable
Age (years) - mean ± SD/median (range)
46 ± 13 / 48 (24-67)
Gender (male/female) - n
21 / 29
Weight (kg) - mean ± SD/median (range)
70 ± 19 / 66.8 (35-121.6)
Height (m) - mean ± SD/median (range)
1.65 ± 13 / 1.7 (1.2-1.9)
BMI (kg/m
2
) - mean ± SD/median (range)
25.7 ± 6.2 / 24.8 (15.8-44)
Diagnosis at transplant - n
Acute Leukemias
16
Lymphomas
17
Myelomas
8
Others
9
Pre-transplantation risk category - n
Low risk
15
High risk
35
Transplant type (n)*
Autologous
23
Allogeneic
21
Conditioning regimen type - n
Autologous HSCT
BEAM
13
Melphalan
8
Bu + CY
2
High dose – Allogeneic HSCT
Bu + CY
6
Bu + CY + VP
3
ICT + CY + VP
1
Bu + Fludarabine
1
Reduced Intensity – Allogeneic HSCT
TBI + Fludarabine
2
Melphalan + Fludarabine
8
GVHD prophylaxis - n
MTX + CsA
19
MMF + CsA
2
Months from diagnosis to HSCT - median (range)
Autologous HSCT
20 (6-211)
Allogeneic HSCT
5 (2-123)
SD: standard deviation; BMI: body mass index; Others: 3 chronic lymphocytic
leukemia, 3 myelodysplastic syndrome and 1 myelofibrosis (myeloproliferative
disorders), 2 chronic myeloid leukemia (CML); Low risk: complete remission or
chronic phase CML; High risk: partial remission, relapse, progression, accelerate phase
for CML; BEAM: carmustine, etoposide, cytarabine and melphalan; Bu: busulfan; CY:
cyclophosphamide; VP: etoposide; TBI: total body irradiation; GVHD: graft versus host
disease; MTX: methotrexate; CsA: cyclosporine; MMF: mycophenolate mofetil
*Six patients did not perform transplant