Graft Vs Host DiseaseRESTARTNCT05236062
Impact of Exercise on the Complications of Corticosteroids in Patients With GVHD: the RESTART Trial
A study testing Exercise in people with Graft Vs Host Disease and Acute-graft-versus-host Disease, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial summary
This study is about determining if an aerobic and resistance exercise intervention is feasible in patients diagnosed with acute or chronic GVHD (Graft-Versus-Host Disease) after having an allogeneic stem cell transplant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Graft Vs Host Disease, Acute-graft-versus-host Disease, Chronic Graft-versus-host-disease
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Apr 2022to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years old; children under the age of 18 will be excluded due to rarity of disease
- Newly diagnosed with acute or chronic GVHD, starting corticosteroids at a dose of .20 mg/kg or greater for the first time since transplant
- Received allogeneic stem cell transplant (any conditioning, any donor) at Dana-Farber Cancer Institute
- Physician's clearance to participate in moderate-vigorous intensity exercise
- Speak English
- Currently participate in less than 60 minutes of structured exercise/week
- Willing to travel to Dana-Farber Cancer Institute for necessary data collection
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Have a plan for hospital admission within the next 13 weeks at the time of recruitment
- If patients are not enrolled within 14 days after initial steroid treatment, they will be ineligible
- Pre-existing musculoskeletal or cardiorespiratory conditions
- Patients should not have any uncontrolled illness including ongoing or active infection, uncontrolled diabetes, hypertension, or thyroid disease
- Patients may not be receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy
- Patients with other active malignancies
Show all 9Show fewer
- Participate in more than 60 minutes of structured exercise/week
- Unable to travel to Dana-Farber Cancer Institute for necessary data collection
- Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
Official title: Impact of Exercise on the Complications of Corticosteroids in Patients With Graft-Versus-Host Disease Following Allogeneic Stem Cell Transplantation: the RESTART Trial
This study is about determining if an aerobic and resistance exercise intervention is feasible in patients diagnosed with acute or chronic GVHD (Graft-Versus-Host Disease) after having an allogeneic stem cell transplant.
The names of the study interventions involved in this study are:
- Aerobic and resistance exercise (A+R) - Home-based aerobic and resistance exercise program
- Attention control (AC) - Home-based stretching program
Read the detailed description
This research study is a feasibility study, which is the first-time investigators are examining an aerobic and resistance exercise (A+R) in patients diagnosed with acute or chronic GVHD after having an allogeneic stem cell transplant and if participating in a specific exercise program can improve glycemic control, body composition, physical fitness and function, and patient-reported outcomes.
This study consists of participants randomly assigned in 2(A+R):1(AC) ratio to one of two groups:
- Aerobic and resistance exercise (A+R), or
- Attention control (AC)
The A+R group will be asked to perform aerobic exercise, which can improve cardiovascular (heart) and lung function, and resistance exercise (e.g., dumbbell lifting), to help build muscle mass and strength. The AC group will be asked to perform stretching only and not to change their activity behavior.
All participants will also undergo four testing visits involving four blood draws and three body composition scans via a dual-energy x-ray absorptiometry (DXA).
Participants will be in this research study for 6 months.
It is expected that about 36 people will take part in this research study.
- Being tested
- Exercise, Attention control
- Keywords
- Graft Vs Host Disease, Acute-graft-versus-host Disease, Chronic Graft-versus-host-disease, Corticosteroids, Allogeneic stem cell transplant
- Medical subject headings
- Graft vs Host Disease, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
aerobic and resistance exercise
Attention controlBehavioural
stretching
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Experimental | Home-based, virtually supervised via Zoom, 3x weekly for 12-weeks aerobic and resistance exercise program
Participants will also undergo four testing visits across 6-month period. Tests will include four blood draws and three body composition scans via a dual-energy x-ray absorptiometry (DXA). Receives: Behavioral: Exercise |
| Attention control Group | Experimental | Home-based, 12-week stretching program only with participants asked not to change their activity behavior.
Participants will also undergo four testing visits across 6-month period. Tests will include four blood draws and three body composition scans via a dual-energy x-ray absorptiometry (DXA). Receives: Behavioral: Attention control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients completing the exercise intervention sessions
The primary outcome is feasibility and will be assessed by the proportion of patients completing the exercise intervention sessions with >70% completion considered feasible.
Measured: 12 weeks
Secondary outcomes (14)
Glycemic control level
Glycemic control level change will be measured by Homeostasis Model Assessment (HOMA). Differences between post- and pre-intervention will be assessed using paired t-test or Wilcoxon signed-rank test. For binary outcomes, it will be a calculation of the proportion and corresponding 95% exact CI.
Measured: Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up
Body Composition
Body Composition Index change will be measured by Dual Energy X-Ray Absorptiometry (DEXA). Differences in lean mass, fat mass, and body fat % between post- and pre-intervention will be assessed using paired t-test or Wilcoxon signed-rank test. For binary outcomes, it will be a calculation of the proportion and corresponding 95% exact CI.
Measured: Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up
Cardiopulmonary Fitness
Cardiopulmonary fitness will be measured by a submaximal graded exercise cycling test. Differences between post- and pre-intervention will be assessed using paired t-test or Wilcoxon signed-rank test. For binary outcomes, it will be a calculation of the proportion and corresponding 95% exact CI.
Measured: Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up
Physical function - Margaria Stair Climb
Functional power will be measured using the Margaria Stair Climb test. Differences between post- and pre-intervention will be assessed using paired t-test or Wilcoxon signed-rank test. For binary outcomes, it will be a calculation of the proportion and corresponding 95% exact CI.
Measured: Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up
Physical Fitness
Physical Fitness will be measured by the short physical performance battery (SPPB). Differences between post- and pre-intervention will be assessed using paired t-test or Wilcoxon signed-rank test. For binary outcomes, it will be a calculation of the proportion and corresponding 95% exact CI.
Measured: Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up
Physical Function - Handgrip Strength
Handgrip strength will be measured by a hand-held dynamometer. Differences between post- and pre-intervention will be assessed using paired t-test or Wilcoxon signed-rank test. For binary outcomes, it will be a calculation of the proportion and corresponding 95% exact CI.
Measured: Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up
Physical Function - Timed Up and Go
Physical function will be assessed with the timed-up-and-go (TUG) test. Differences between post- and pre-intervention will be assessed using paired t-test or Wilcoxon signed-rank test. For binary outcomes, it will be a calculation of the proportion and corresponding 95% exact CI.
Measured: Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up
Physical Function - 6 minute walk test
Physical function will be assessed with the 6 minute walk test (6MWT). Differences between post- and pre-intervention will be assessed using paired t-test or Wilcoxon signed-rank test. For binary outcomes, it will be a calculation of the proportion and corresponding 95% exact CI.
Measured: Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up
Muscular Strength
Muscular strength will be assessed with a 10 repetition maximum test. Differences between post- and pre-intervention will be assessed using paired t-test or Wilcoxon signed-rank test. For binary outcomes, it will be a calculation of the proportion and corresponding 95% exact CI.
Measured: Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up
Patient reported outcomes - Fatigue
Fatigue will be measured by the PROMIS cancer fatigue short form. Differences between post- and pre-intervention will be assessed using paired t-test or Wilcoxon signed-rank test. For binary outcomes, it will be a calculation of the proportion and corresponding 95% exact CI.
Measured: Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up
Patient reported outcomes - Function
Function will be measured by the Vulnerable Elders Survey (VES). Differences between post- and pre-intervention will be assessed using paired t-test or Wilcoxon signed-rank test. For binary outcomes, it will be a calculation of the proportion and corresponding 95% exact CI.
Measured: Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up
Patient reported outcomes - Quality of Life
Quality of life will be assessed by the functional assessment of cancer therapy - bone marrow transplant (FACT-BMT). Differences between post- and pre-intervention will be assessed using paired t-test or Wilcoxon signed-rank test. For binary outcomes, it will be a calculation of the proportion and corresponding 95% exact CI.
Measured: Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up
Patient reported outcomes - Anxiety and Depression
Anxiety and depression will be assessed by the Hospital Anxiety and Depression Scale (HADS). Differences between post- and pre-intervention will be assessed using paired t-test or Wilcoxon signed-rank test. For binary outcomes, it will be a calculation of the proportion and corresponding 95% exact CI. The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression complains. Patients were defined as having anxiety or depression or both if the score was 8 or more in the corresponding subscale.
Measured: Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up
Patient reported outcomes - Sleep
Sleep will be assessed by the Pittsburg sleep quality index (PSQI). Differences between post- and pre-intervention will be assessed using paired t-test or Wilcoxon signed-rank test. For binary outcomes, it will be a calculation of the proportion and corresponding 95% exact CI.
Measured: Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start14 Apr 2022
- Primary completion28 Feb 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft Vs Host DiseaseStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina Dieli-Conwright, PhD, Dana-Farber Cancer Institute
- Investigators
- Christina Dieli-Conwright, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05236062
- Sponsor's protocol ID
- 21-618
- Acronym
- RESTART
- Status last verified
- Oct 2026
- First submitted
- 19 Jan 2022
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Exercise on the Complications of Corticosteroids in Patients With Graft-Versus-Host Disease Following Allogeneic Stem Cell Transplantation: the RESTART Trial
- ClinicalTrials.gov ID
- NCT05236062
- Acronym / sponsor ID
- RESTART / 21-618
- Keywords
- Graft Vs Host Disease, Acute-graft-versus-host Disease, Chronic Graft-versus-host-disease, Corticosteroids, Allogeneic stem cell transplant
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- 14 Apr 2022 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 11 Feb 2022 (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 study is about determining if an aerobic and resistance exercise intervention is feasible in patients diagnosed with acute or chronic GVHD (Graft-Versus-Host Disease) after having an allogeneic stem cell transplant.
The names of the study interventions involved in this study are:
- Aerobic and resistance exercise (A+R) - Home-based aerobic and resistance exercise program
- Attention control (AC) - Home-based stretching program
Detailed description
This research study is a feasibility study, which is the first-time investigators are examining an aerobic and resistance exercise (A+R) in patients diagnosed with acute or chronic GVHD after having an allogeneic stem cell transplant and if participating in a specific exercise program can improve glycemic control, body composition, physical fitness and function, and patient-reported outcomes.
This study consists of participants randomly assigned in 2(A+R):1(AC) ratio to one of two groups:
- Aerobic and resistance exercise (A+R), or
- Attention control (AC)
The A+R group will be asked to perform aerobic exercise, which can improve cardiovascular (heart) and lung function, and resistance exercise (e.g., dumbbell lifting), to help build muscle mass and strength. The AC group will be asked to perform stretching only and not to change their activity behavior.
All participants will also undergo four testing visits involving four blood draws and three body composition scans via a dual-energy x-ray absorptiometry (DXA).
Participants will be in this research study for 6 months.
It is expected that about 36 people will take part in this research study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Experimental | Behavioral: ExerciseHome-based, virtually supervised via Zoom, 3x weekly for 12-weeks aerobic and resistance exercise program Participants will also undergo four testing visits across 6-month period. Tests will include four blood draws and three body composition scans via a dual-energy x-ray absorptiometry (DXA). |
| Attention control Group | Experimental | Behavioral: Attention controlHome-based, 12-week stretching program only with participants asked not to change their activity behavior. Participants will also undergo four testing visits across 6-month period. Tests will include four blood draws and three body composition scans via a dual-energy x-ray absorptiometry (DXA). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Over 18 years old; children under the age of 18 will be excluded due to rarity of disease
- Newly diagnosed with acute or chronic GVHD, starting corticosteroids at a dose of .20 mg/kg or greater for the first time since transplant
- Received allogeneic stem cell transplant (any conditioning, any donor) at Dana-Farber Cancer Institute
- Physician's clearance to participate in moderate-vigorous intensity exercise
- Speak English
Key exclusion criteria (9 listed)
- Have a plan for hospital admission within the next 13 weeks at the time of recruitment
- If patients are not enrolled within 14 days after initial steroid treatment, they will be ineligible
- Pre-existing musculoskeletal or cardiorespiratory conditions
- Patients should not have any uncontrolled illness including ongoing or active infection, uncontrolled diabetes, hypertension, or thyroid disease
- Patients may not be receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy
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 |
|---|---|---|
| Exerciseaerobic and resistance exercise | Behavioural | Exercise Group |
| Attention controlstretching | Behavioural | Attention control Group |
Primary outcome
Proportion of patients completing the exercise intervention sessions
Time frame: 12 weeks
The primary outcome is feasibility and will be assessed by the proportion of patients completing the exercise intervention sessions with >70% completion considered feasible.
14 secondary outcomes
Glycemic control level
Time frame: Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up
Body Composition
Time frame: Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up
Cardiopulmonary Fitness
Time frame: Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up
Physical function - Margaria Stair Climb
Time frame: Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up
Physical Fitness
Time frame: Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up
Physical Function - Handgrip Strength
Time frame: Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up
Physical Function - Timed Up and Go
Time frame: Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up
Physical Function - 6 minute walk test
Time frame: Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up
Muscular Strength
Time frame: Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up
Patient reported outcomes - Fatigue
Time frame: Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up
Patient reported outcomes - Function
Time frame: Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up
Patient reported outcomes - Quality of Life
Time frame: Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up
Patient reported outcomes - Anxiety and Depression
Time frame: Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up
Patient reported outcomes - Sleep
Time frame: Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Christina Dieli-Conwright principal investigator
Dana-Farber Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Graft Vs Host Disease and Acute-graft-versus-host Disease, run by Dana-Farber Cancer Institute at 2 sites in United States.
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 8 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Proportion of patients completing the exercise intervention sessions (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2026.