Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| i 70118 | Other Identifier | Roswell Park Cancer Institute |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This trial studies how well strength training works in improving bone health, pain, and quality of life in patients with multiple myeloma. Weekly physical activity may improve bone recovery, reduce pain, and increase quality of life in patients with multiple myeloma.
PRIMARY OBJECTIVES:
SECONDARY OBJECTIVES:
I. To assess the adherence rate of patients during a 6 month intervention program.
II. To assess the eligibility and recruitment rate for the trial among patients with multiple myeloma.
EXPLORATORY OBJECTIVES:
I. Comparison of disease activity parameters, physical activity level, clinical symptoms, medication, psycho-oncological parameters before, during and after intervention.
II. Determine factors that may influence a persons' willingness to participate in the trial.
III. Investigate "immune fitness" by frequencies and function of immune cell subsets in peripheral blood.
OUTLINE: Patients are assigned to 1 of 2 cohorts.
COHRT 1 (STRENGTH TRAINING): Patients receive a Fitbit to track their physical activity, and complete an in-person personalized and supervised full-body strength training program over 1 hour twice weekly (BID) up to 52 sessions for 6 months.
COHORT 2 (BEHAVIORAL INTERVENTION): Patients receive a Fitbit to track their physical activity, and complete an unsupervised walking program daily at home, increasing physical activity stepwise weekly, for 6 months.
After completion of study, patients are followed up every 3 months for 1 year.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 2 (walking program) | Active Comparator | Patients receive a Fitbit to track their physical activity, and complete an unsupervised walking program daily at home, increasing physical activity stepwise weekly, for 6 months. |
|
| Cohort 1 (strength training) | Experimental | Patients receive a Fitbit to track their physical activity, and complete an in-person personalized and supervised full-body strength training program over 1 hour BID up to 52 sessions for 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FitBit | Device | Wear Fitbit |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility rate | Will be defined as the proportion of enrolled patients who are still on study at the end of 6 months. Analysis will be done via computing a two-sided 95% confidence interval for the true proportion using Clopper-Pearson method. | At 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence rate (Cohort 1) | Will be defined as the proportion of patients remaining on study at 6 months who complete >= 80% of the intervention activities. Analysis will be done via computing a two-sided 95% confidence interval for the true proportion using Clopper-Pearson method. | At 6 months |
| Adherence rate (Cohort 2) |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in lab parameters | Comparison of parameters before and after intervention for the exploratory endpoints will proceed using two-sided paired t-tests for significance at the alpha = 0.05 level for continuous measures, and sign- tests for ordinal outcomes. Multiple testing corrections will make use of Bonferroni adjustments. | Before and after strength training program up to 1 year |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jens Hillengass | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
Not provided
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D055070 | Resistance Training |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Quality-of-Life Assessment |
| Other |
Ancillary studies |
|
|
| Questionnaire Administration | Other | Ancillary studies |
|
| Resistance Training | Other | Complete strength training |
|
|
| STEPS to Enhance Physical Activity | Behavioral | Complete a walking program |
|
|
Will be defined as the proportion of patients whose average daily step counts each week are at or above their goal for that week at least 20/26 weeks, or 80% of the weeks. |
| At 6 months |
| Clinical performance | Comparison of parameters before and after intervention for the exploratory endpoints will proceed using two-sided paired t-tests for significance at the alpha = 0.05 level for continuous measures, and sign- tests for ordinal outcomes. Multiple testing corrections will make use of Bonferroni adjustments. | Before and after strength training program up to 1 year |
| Physical activity level | Comparison of parameters before and after intervention for the exploratory endpoints will proceed using two-sided paired t-tests for significance at the alpha = 0.05 level for continuous measures, and sign- tests for ordinal outcomes. Multiple testing corrections will make use of Bonferroni adjustments. | Before and after strength training program up to 1 year |
| Pain | Comparison of parameters before and after intervention for the exploratory endpoints will proceed using two-sided paired t-tests for significance at the alpha = 0.05 level for continuous measures, and sign- tests for ordinal outcomes. Multiple testing corrections will make use of Bonferroni adjustments. | Before and after strength training program up to 1 year |
| Polyneuropathy | Comparison of parameters before and after intervention for the exploratory endpoints will proceed using two-sided paired t-tests for significance at the alpha = 0.05 level for continuous measures, and sign- tests for ordinal outcomes. Multiple testing corrections will make use of Bonferroni adjustments. | Before and after strength training program up to 1 year |
| Opioid and other drug consumption | Comparison of parameters before and after intervention for the exploratory endpoints will proceed using two-sided paired t-tests for significance at the alpha = 0.05 level for continuous measures, and sign- tests for ordinal outcomes. Multiple testing corrections will make use of Bonferroni adjustments. | Before and after strength training program up to 1 year |
| Psycho-oncological parameters | Comparison of parameters before and after intervention for the exploratory endpoints will proceed using two-sided paired t-tests for significance at the alpha = 0.05 level for continuous measures, and sign- tests for ordinal outcomes. Multiple testing corrections will make use of Bonferroni adjustments. | Before and after strength training program up to 1 year |
| Fatigue | Comparison of parameters before and after intervention for the exploratory endpoints will proceed using two-sided paired t-tests for significance at the alpha = 0.05 level for continuous measures, and sign- tests for ordinal outcomes. Multiple testing corrections will make use of Bonferroni adjustments. | Before, during and after strength training program |
| Reasons why patients do not participate in the trial | Comparison of parameters before and after intervention for the exploratory endpoints will proceed using two-sided paired t-tests for significance at the alpha = 0.05 level for continuous measures, and sign- tests for ordinal outcomes. Multiple testing corrections will make use of Bonferroni adjustments. This will be assessed by analysis of the screening questionnaires and the checklist. | Before and after strength training program up to 1 year |
| "Immune fitness" frequencies and function of immune cell subsets | Will be measured in peripheral blood. Comparison of parameters before and after intervention for the exploratory endpoints will proceed using two-sided paired t-tests for significance at the alpha = 0.05 level for continuous measures, and sign- tests for ordinal outcomes. Multiple testing corrections will make use of Bonferroni adjustments. This will be assessed by analysis of the screening questionnaires and the checklist. | Before and after strength training program up to 1 year |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |