Condition category
Cancer
Date applied
24/03/2017
Date assigned
03/04/2017
Last edited
31/03/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Hematologic cancers are cancers of the blood. Hematopoietic stem cell transplantation (HSCT) is the primary treatment for hematologic cancers which involves replacing the patient’s own immune cells with donated healthy stem cells taken from the bone marrow or blood. Patients who undergo HSCT are at risk of suffering from treatment-related problems. Patients are required to be isolated in a bioclean room (a room without any bacteria), and this can cause patients to be limited in their mobility in these small rooms. This can result in the loss of physical function, fatigue, psychological problems, and decrease of quality of life (QOL). These problems lead to delays in recovery, which can cause delays in being discharged from hospital. Exercise is known to improve physical function, fatigue, depression, QOL, and immune function. The aim of this study is to examine the effect of evidence-based exercise on the body composition and physical fitness, and recovery in HSCT patients.

Who can participate?
Adults aged 18 and older who have blood cancers who are receiving HSCT.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive a non-supervised daily exercise plan during their hospital stay. The programme is developed for participants so that they can do it in their hospital room. It includes bed stretching and strengthening exercises. Those in the second group receive their usual care. Participants are assessed for their body composition, physical fitness levels.

What are the possible benefits and risks of participating?
Participants may benefit from improvements in muscle mass and physical fitness. There are no notable risks with participating.

Where is the study run from?
Yonsei Severance Hospital (South Korea)

When is the study starting and how long is it expected to run for?
February 2017 to September 2017

Who is funding the study?
Yonsei Severance Hospital (South Korea)

Who is the main contact?
1. Dr June Won Cheong (Scientific)
2. Professor Justin Jeon (Scientific)

Trial website

Contact information

Type

Scientific

Primary contact

Dr June Won Cheong

ORCID ID

Contact details

50 Yonsei-ro
Seodaemun-gu
Severance Hospital
Seoul
120-752
Korea
South

Type

Scientific

Additional contact

Prof Justin Jeon

ORCID ID

Contact details

50 Yonsei-ro
Seodaemun-gu
Yonsei University
Seoul
120-749
Korea
South

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Effects of evidence-based exercise on body composition, physical fitness, and recovery-related parameters in Hematopoietic Stem Cell Transplantation Patients: A randomized controlled trial

Acronym

Study hypothesis

Evidence-based exercise will improve muscle mass, physical fitness, and recovery-related parameters in Hematopoietic stem cell transplantation patients.

Ethics approval

Institutional Ethics Review Board at Yonsei University College of Medicine, 16/03/2017, ref: 4-2017-0058

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

No participant information sheet available

Condition

Hematopoietic Stem Cell Transplantation Patients

Intervention

Participants are randomly allocated to either the exercise group or to the control group. Randomisation is done using stratified randomisation according to gender and transplanting.

Exercise group: Participants in this group conduct a non-supervised exercise intervention programme at least one time per day during hospitalization in addition to their usual care. The exercise program is divided into three types according to patients’ daily condition. The exercise program is divided into two types according to hospital room type. The exercise program includes bed stretching, resistance exercise, and joint strengthening exercise. Participants in exercise group are educated exercise program by exercise instructor at admission and record daily exercise log book during hospitalization.

Control group: Participants in control group will receive only usual care including chemotherapy, medication, blood count monitoring, and managing side effects like general patients.

Participants are assessed for their body composition and physical fitness using various tests at baseline, after entering the bio-clean room and when they are discharged from the hospital.

Intervention type

Other

Phase

Drug names

Primary outcome measures

1. Body composition (muscle mass) is measured using the BIA machine (Inbody IH-U070R, Biospace, Korea) at baseline and after entering a bio-clean room, and discharge from hospital
2. Physical fitness is measured using the six min-walking test (or 2 minute walking), step test, hand-grip strength, sit and reach, 8 foot up and go test, and chair stand at baseline and after entering a bio-clean room, and discharge from hospital

Secondary outcome measures

1. Time to platelet engraftment is measured using hospital charts daily during hospital stay
2. Absolute neutrophil count is measured using hospital charts daily during hospital stay
3. Amount of blood transfusion is measured using hospital charts daily during hospital stay
4. Amout nof meal intake is measured using hospital charts daily during hospital stay
5. Length of hospital stay is measured using hospital charts daily during hospital stay
6. Symptoms are measured using the Korean version of the M. D. Anderson symptom inventory (MDASI) at baseline and after entering a bio-clean room, and discharge from hospital
7. Satisfaction in exercise program is measured using Satisfaction with Life Scale (SLS) at discharge from hospital

Overall trial start date

15/02/2017

Overall trial end date

15/09/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with leukemia, lymphoma, or multiple myeloma who are scheduled to receive autologousor allogeneic HSCT
2. Aged between 18 and 65 years
3. Ability to understand and provide written informed consent in Korea
4. No evidence of cardiac or pulmonary failure associated with treatment
5. Ability to conduct low and moderate intensity exercise program

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

15 patients in each group

Participant exclusion criteria

1. Existing evidence of recurrent or metastatic disease
2. Pregnant or planned to be pregnant within six month
3. Any condition unsuitable for participation in the study

Recruitment start date

16/03/2017

Recruitment end date

15/08/2017

Locations

Countries of recruitment

Korea, South

Trial participating centre

Yonsei Severance Hospital
50 Yonsei-ro Seodaemun-gu
Seoul
120-752
Korea, South

Sponsor information

Organisation

Yonsei Severance Hospital

Sponsor details

50 Yonsei-ro
Seodaemun-gu
Seoul
120-752
Korea
South

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Yonsei University

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

Korea, South

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal

IPD sharing plan:
The datasets generated during and/or analysed during the current study is not expected to be made available due to confidentiality reasons.

Intention to publish date

15/09/2018

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes