Autologous Hematopoietic Stem Cell Transplantation, Hematologic Malignacy
Conditions
Keywords
Autologous bone marrow transplantation, exercise, white blood cell, neutrophil, lymphocite
Brief summary
This interventional study assigns participants undergoing autologous hematopoietic stem cell transplantation to a supervised exercise program or usual care. The exercise program includes strength, endurance, and flexibility sessions for 8 weeks, 5 days per week. The control group receives usual care without a structured exercise program.
Detailed description
This interventional study is conducted at Erciyes University Faculty of Medicine, Department of Hematology in patients scheduled for autologous hematopoietic stem cell transplantation. Eligible participants are assigned to either a supervised exercise program or usual care. The exercise intervention consists of strength, endurance, and flexibility sessions performed five days per week for eight weeks under supervision. Participants in the control group receive standard medical care without a structured exercise program. The study aims to examine the effects of the exercise program during the transplantation process in patients undergoing autologous stem cell transplantation.
Interventions
BEHAVIORALExercise Program
8-week structured strength, endurance and flexibility exercise program performed 5 days per week. Resistance intensity was determined using 1RM, aerobic intensity using Karvonen method (40-60%), monitored with Borg Scale
Sponsors
TC Erciyes University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessors and data analysts were blinded to group allocation. Due to the nature of the exercise intervention, participants and exercise supervisors were not blinded.
Intervention model description
analyses were completed with 8 patients in the exercise group and 7 patients in the control group. The exercise group participated in an 8-week exercise program consisting of endurance, strength, and flexibility exercises performed five days per week. The 1-repetition maximum (1RM) principle was used to determine resistance training intensity, while the Karvonen method (40-60%) was used to prescribe aerobic exercise intensity. Exercise intensity was monitored using the 24-point Borg Scale. The control group did not participate in any structured exercise program. Assessments were conducted at four time points: 1. Four weeks before transplantation 2. Two days before transplantation 3. During the engraftment period 4. Two weeks after engraftment
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years, \<65 years * Able to exercise at time of enrolment. * no methastasis
Exclusion criteria
- Unable to communicate or read in Turkish, * Contraindications to 3 T MRI (e.g., pacemaker or implanted metallic device). * co-morbid cardiac disease * painful joint
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Handgrip Strength During the Transplantation Process | Baseline (4 weeks before transplantation),pre-transplant (2 days before), during engraftment, and 2 weeks post-engraftment 8(approximately 10-12 weeks total follow-up) | Change in handgrip strength measured using a hand dynamometer at four time points: 4 weeks before transplantation, 2 days before transplantation, during the engraftment period, and 2 weeks after engraftment in patients undergoing autologous bone marrow transplantation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Back Strength | Baseline (4 weeks before transplantation), pre-transplant (2 days before), during engraftment, and 2 weeks post-engraftment (approximately 10-12 weeks total follow-up). | Back strength measured using a back dynamometer (kg) at four time points during the transplantation process. |
| Change in Leg Strength | Baseline (4 weeks before transplantation), pre-transplant (2 days before), during engraftment, and 2 weeks post-engraftment (approximately 10-12 weeks total follow-up). | Leg strength measured using a leg dynamometer (kg) at four time points during the transplantation process. |
| Change in Waist Flexibility | Baseline (4 weeks before transplantation), pre-transplant (2 days before), during engraftment, and 2 weeks post-engraftment (approximately 10-12 weeks total follow-up). | Waist flexibility assessed by sit-and-reach test (cm) at four time points during the transplantation process. |
| Change in White Blood Cell Count | Baseline (4 weeks before transplantation), pre-transplant (2 days before), during engraftment, and 2 weeks post-engraftment (approximately 10-12 weeks total follow-up). | White blood cell count (10\^9/L) obtained from routine complete blood count at four time points. |
| Change in Neutrophil Count | Baseline (4 weeks before transplantation), pre-transplant (2 days before), during engraftment, and 2 weeks post-engraftment (approximately 10-12 weeks total follow-up). | Neutrophil count (10\^9/L) obtained from routine complete blood count at four time points. |
| Change in Lymphocyte Count | Baseline (4 weeks before transplantation), pre-transplant (2 days before), during engraftment, and 2 weeks post-engraftment (approximately 10-12 weeks total follow-up). | Lymphocyte count (10\^9/L) obtained from routine complete blood count at four time points. |
| Change in Platelet Count | Baseline (4 weeks before transplantation), pre-transplant (2 days before), during engraftment, and 2 weeks post-engraftment (approximately 10-12 weeks total follow-up). | Platelet count (10\^9/L) obtained from routine complete blood count at four time points. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORMustafa Karakuş, PhD
TC Erciyes University
Outcome results
None listed