Hematologic MalignacyNCT07458854
Exercise in Patients Undergoing Autologous Stem Cell Transplantation: A Randomized Controlled Trial
A study testing Exercise Program in people with Hematologic Malignacy and Autologous Hematopoietic Stem Cell Transplantation, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hematologic Malignacy, Autologous Hematopoietic Stem Cell Transplantation
- What is being tested?
- Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Oct 2014to 10 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Erciyes University Faculty of Sport Science
Kayseri, Kayseri, 38039
About this study
Official title: The Effect of Therapeutic Exercise in Patients Undergoing Autologous Stem Cell Transplantation: A Randomized Controlled Trial
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.
Read the 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.
- Being tested
- Exercise Program
- Keywords
- Autologous bone marrow transplantation, exercise, white blood cell, neutrophil, lymphocite
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise ProgramBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Exercise Intervention In Autologous Stem Cell Transplant Patients:A Randomized Controlled Trial | Experimental | 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:
* 8-week structured exercise program
* Performed 5 days per week
* Included endurance, strength, and flexibility exercises Exercise intensity was determined using the 1-repetition maximum (1RM) principle for resistance training and the Karvonen method (40-60%) for aerobic training. Exercise intensity was monitored using the 24-point Borg Scale.
In addition to standard medical treatment, this group received a structured therapeutic exercise program. Receives: Behavioral: Exercise Program |
| Exercise Intervention-Free Randomized Controlled Study in Autogenous Stem Cell Transplant Patients | No intervention | 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: * Standard medical treatment only * No structured exercise program was implemented This group served as the comparison group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Handgrip Strength During the Transplantation Process
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.
Measured: 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 outcomes (7)
Change in Back Strength
Back strength measured using a back dynamometer (kg) at four time points during the transplantation process.
Measured: 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
Leg strength measured using a leg dynamometer (kg) at four time points during the transplantation process.
Measured: 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
Waist flexibility assessed by sit-and-reach test (cm) at four time points during the transplantation process.
Measured: 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
White blood cell count (10^9/L) obtained from routine complete blood count at four time points.
Measured: 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
Neutrophil count (10^9/L) obtained from routine complete blood count at four time points.
Measured: 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
Lymphocyte count (10^9/L) obtained from routine complete blood count at four time points.
Measured: 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
Platelet count (10^9/L) obtained from routine complete blood count at four time points.
Measured: Baseline (4 weeks before transplantation), pre-transplant (2 days before), during engraftment, and 2 weeks post-engraftment (approximately 10-12 weeks total follow-up).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start14 Oct 2014
- Primary completion20 Oct 2014
- Study completion10 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hematologic MalignacyStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Karakuş, TC Erciyes University
- Investigators
- Mustafa Karakuş, PhD, Principal investigator, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07458854
- Sponsor's protocol ID
- ERU-SPBF-MK-01
- Status last verified
- Mar 2026
- First submitted
- 27 Feb 2026
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to institutional data protection policies and ethical restrictions
Publications
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.
PubMed 19234513Wiskemann 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.
PubMed 18026154Baumann 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.
PubMed 19597418Dimeo 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.
PubMed 9345021
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Therapeutic Exercise in Patients Undergoing Autologous Stem Cell Transplantation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07458854
- Acronym / sponsor ID
- ERU-SPBF-MK-01
- Keywords
- Autologous bone marrow transplantation, exercise, white blood cell, neutrophil, lymphocite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 14 Oct 2014 (actual)
- Primary completion
- 20 Oct 2014 (actual)
- Study completion
- 10 Sep 2018 (actual)
- First posted
- 9 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Exercise Intervention In Autologous Stem Cell Transplant Patients:A Randomized Controlled Trial | Experimental | Behavioral: Exercise ProgramThe 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: * 8-week structured exercise program * Performed 5 days per week * Included endurance, strength, and flexibility exercises Exercise intensity was determined using the 1-repetition maximum (1RM) principle for resistance training and the Karvonen method (40-60%) for aerobic training. Exercise intensity was monitored using the 24-point Borg Scale. In addition to standard medical treatment, this group received a structured therapeutic exercise program. |
| Exercise Intervention-Free Randomized Controlled Study in Autogenous Stem Cell Transplant Patients | No intervention | –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: * Standard medical treatment only * No structured exercise program was implemented This group served as the comparison group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise Program8-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 | Behavioural | Exercise Intervention In Autologous Stem Cell Transplant Patients:A Randomized Controlled Trial |
Primary outcome
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.
7 secondary outcomes
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).
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).
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).
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).
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).
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).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Background: PubMed 19234513Jarden 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.
- Background: PubMed 18026154Wiskemann 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.
- Background: PubMed 19597418Baumann 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.
- Background: PubMed 9345021Dimeo 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.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to institutional data protection policies and ethical restrictions
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mustafa Karakuş, PhD principal investigator
TC Erciyes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Program in people with Hematologic Malignacy and Autologous Hematopoietic Stem Cell Transplantation, run by TC Erciyes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07458854, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.