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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Behavioral | aerobic and resistance exercise |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christina Dieli-Conwright, PhD, MPH | Contact | 617-582-8321 | ChristinaM_Dieli-Conwright@dfci.harvard.edu | |
| Jordan Lane, MS | Contact | 617-582-7494 | jordan_lane@dfci.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Christina Dieli-Conwright | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
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.
Data can be shared no earlier than 1 year following the date of publication
Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
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| Attention control |
| Behavioral |
stretching |
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up |
| Dana Farber Cancer Institute | Recruiting | Boston | Massachusetts | 02215 | United States |
|
| ID | Term |
|---|---|
| D006086 | Graft vs Host Disease |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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