Exercise in Patients Undergoing Autologous Stem Cell Transplantation: A Randomized Controlled Trial

NCT07458854 | Completed

• 1 other identifier: ERU-SPBF-MK-01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematologic Malignacy; Autologous Hematopoietic Stem Cell Transplantation

Keywords

Autologous bone marrow transplantation; exercise; white blood cell; neutrophil; lymphocite

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  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

  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

  Baseline (4 weeks before transplantation), pre-transplant (2 days before), during engraftment, and 2 weeks post-engraftment (approximately 10-12 weeks total follow-up).

Study Arms (2)

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.

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.

Interventions

Exercise Program BEHAVIORAL

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

Exercise Intervention In Autologous Stem Cell Transplant Patients:A Randomized Controlled Trial

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years, \<65 years
• Able to exercise at time of enrolment.
• no methastasis

You may not qualify if:

• Contraindications to 3 T MRI (e.g., pacemaker or implanted metallic device).
• co-morbid cardiac disease
• painful joint

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes University Faculty of Sport Science

Kayseri, Kayseri, 38039, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 19234513 BACKGROUND

• 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.

  PMID: 18026154 BACKGROUND

• 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.

  PMID: 19597418 BACKGROUND

• 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.

  PMID: 9345021 BACKGROUND

MeSH Terms

Conditions

Motor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Mustafa Karakuş, PhD

  TC Erciyes University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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

Study Record Dates

• First Submitted: February 27, 2026
• First Posted: March 9, 2026
• Study Start: October 14, 2014
• Primary Completion: October 20, 2014
• Study Completion: September 10, 2018
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)