- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07458854
Exercise in Patients Undergoing Autologous Stem Cell Transplantation: A Randomized Controlled Trial
The Effect of Therapeutic Exercise in Patients Undergoing Autologous Stem Cell Transplantation: A Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kayseri
-
Kayseri, Kayseri, Turkey (Türkiye), 38039
- Erciyes University Faculty of Sport Science
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Exercise Intervention In Autologous Stem Cell Transplant Patients:A Randomized Controlled Trial
The Exercise Group consisted of patients scheduled to undergo autologous bone marrow transplantation who were randomly assigned to the intervention arm of the study. Initial number of participants: 12 Included in final analysis: 8 Intervention:
In addition to standard medical treatment, this group received a structured therapeutic exercise 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
|
|
No Intervention: Exercise Intervention-Free Randomized Controlled Study in Autogenous Stem Cell Transplant Patients
The Control Group consisted of patients randomly assigned to the control arm of the study. Initial number of participants: 12 Included in final analysis: 7 Intervention:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Handgrip Strength During the Transplantation Process
Time Frame: 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.
|
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)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Back Strength
Time Frame: 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.
|
Baseline (4 weeks before transplantation), pre-transplant (2 days before), during engraftment, and 2 weeks post-engraftment (approximately 10-12 weeks total follow-up).
|
|
Change in Leg Strength
Time Frame: 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.
|
Baseline (4 weeks before transplantation), pre-transplant (2 days before), during engraftment, and 2 weeks post-engraftment (approximately 10-12 weeks total follow-up).
|
|
Change in Waist Flexibility
Time Frame: 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.
|
Baseline (4 weeks before transplantation), pre-transplant (2 days before), during engraftment, and 2 weeks post-engraftment (approximately 10-12 weeks total follow-up).
|
|
Change in White Blood Cell Count
Time Frame: 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.
|
Baseline (4 weeks before transplantation), pre-transplant (2 days before), during engraftment, and 2 weeks post-engraftment (approximately 10-12 weeks total follow-up).
|
|
Change in Neutrophil Count
Time Frame: 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.
|
Baseline (4 weeks before transplantation), pre-transplant (2 days before), during engraftment, and 2 weeks post-engraftment (approximately 10-12 weeks total follow-up).
|
|
Change in Lymphocyte Count
Time Frame: 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.
|
Baseline (4 weeks before transplantation), pre-transplant (2 days before), during engraftment, and 2 weeks post-engraftment (approximately 10-12 weeks total follow-up).
|
|
Change in Platelet Count
Time Frame: 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.
|
Baseline (4 weeks before transplantation), pre-transplant (2 days before), during engraftment, and 2 weeks post-engraftment (approximately 10-12 weeks total follow-up).
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mustafa Karakuş, PhD, TC Erciyes University
Publications and helpful links
General Publications
- Wiskemann J, Huber G. Physical exercise as adjuvant therapy for patients undergoing hematopoietic stem cell transplantation. Bone Marrow Transplant. 2008 Feb;41(4):321-9. doi: 10.1038/sj.bmt.1705917. Epub 2007 Nov 19.
- Jarden M, Baadsgaard MT, Hovgaard DJ, Boesen E, Adamsen L. A randomized trial on the effect of a multimodal intervention on physical capacity, functional performance and quality of life in adult patients undergoing allogeneic SCT. Bone Marrow Transplant. 2009 May;43(9):725-37. doi: 10.1038/bmt.2009.27. Epub 2009 Feb 23.
- Baumann FT, Kraut L, Schule K, Bloch W, Fauser AA. A controlled randomized study examining the effects of exercise therapy on patients undergoing haematopoietic stem cell transplantation. Bone Marrow Transplant. 2010 Feb;45(2):355-62. doi: 10.1038/bmt.2009.163. Epub 2009 Jul 13.
- Dimeo F, Fetscher S, Lange W, Mertelsmann R, Keul J. Effects of aerobic exercise on the physical performance and incidence of treatment-related complications after high-dose chemotherapy. Blood. 1997 Nov 1;90(9):3390-4.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavior
- Motor Activity
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Therapeutics
- Physical Therapy Modalities
- Patient Care
- Exercise Therapy
- Rehabilitation
- Aftercare
- Continuity of Patient Care
- Physical Conditioning, Human
- Exercise
- Resistance Training
Other Study ID Numbers
- ERU-SPBF-MK-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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