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Strength Training in Improving Pain and Quality of Life in Patients With Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT03793907
Recruitment Status : Recruiting
First Posted : January 4, 2019
Last Update Posted : September 10, 2021
Sponsor:
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Plasma Cell Myeloma Device: FitBit Other: Quality-of-Life Assessment Other: Questionnaire Administration Other: Resistance Training Behavioral: STEPS to Enhance Physical Activity Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

  • I. To assess the feasibility of a 6 month, twice weekly supervised strength training intervention in patients with multiple myeloma. (Cohort 1)
  • II. To assess the feasibility of a 6 month behavioral intervention to prompt an increase in weekly physical activity in patient with multiple myeloma. (Cohort 2)

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Feasibility of Strength Training and Impact on Pain and Quality of Life in Patients With Multiple Myeloma
Actual Study Start Date : September 5, 2019
Estimated Primary Completion Date : October 11, 2021
Estimated Study Completion Date : October 11, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Active Comparator: Cohort 2 (walking program)
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.
Device: FitBit
Wear Fitbit

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Behavioral: STEPS to Enhance Physical Activity
Complete a walking program
Other Names:
  • STEPS
  • STEPS Intervention
  • STEPS to Enhance Physical Activity (STEPS)

Experimental: Cohort 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 BID up to 52 sessions for 6 months.
Device: FitBit
Wear Fitbit

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Other: Resistance Training
Complete strength training
Other Name: Strength Training




Primary Outcome Measures :
  1. Feasibility rate [ Time Frame: At 6 months ]
    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.


Secondary Outcome Measures :
  1. Adherence rate (Cohort 1) [ Time Frame: At 6 months ]
    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.

  2. Adherence rate (Cohort 2) [ Time Frame: At 6 months ]
    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.


Other Outcome Measures:
  1. Differences in lab parameters [ Time Frame: Before and after strength training program up to 1 year ]
    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.

  2. Clinical performance [ Time Frame: Before and after strength training program up to 1 year ]
    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.

  3. Physical activity level [ Time Frame: Before and after strength training program up to 1 year ]
    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.

  4. Pain [ Time Frame: Before and after strength training program up to 1 year ]
    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.

  5. Polyneuropathy [ Time Frame: Before and after strength training program up to 1 year ]
    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.

  6. Opioid and other drug consumption [ Time Frame: Before and after strength training program up to 1 year ]
    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.

  7. Psycho-oncological parameters [ Time Frame: Before and after strength training program up to 1 year ]
    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.

  8. Fatigue [ Time Frame: Before, during and after strength training program ]
    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.

  9. Reasons why patients do not participate in the trial [ Time Frame: Before and after strength training program up to 1 year ]
    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.

  10. "Immune fitness" frequencies and function of immune cell subsets [ Time Frame: Before and after strength training program up to 1 year ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1
  • Have a diagnosis of multiple myeloma
  • Show no signs of comorbidities, myeloma symptoms, or treatment side effects that would put them in danger when participating in the study according to the physician's discretion
  • Are able to understand and follow assessment and training procedures
  • Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

  • Current and symptomatic pathological fracture(s) or severely advanced instability of the musculo-skeletal system
  • Acute bone instability as assessed by whole body low-dose computed tomography and evaluated by an experienced neuro- and spine surgeon
  • Major comorbidities that would cause danger to the patient when participating in the study. Examples are cardiac or pulmonary and infectious diseases that would have a risk of progression if the patient took part in the study
  • Unwilling or unable to follow protocol requirements
  • Any condition which in the investigator's opinion deems the participant an unsuitable candidate to take part in study intervention (comorbidities, myeloma symptoms, treatment side effects)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03793907


Locations
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United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Jens Hillengass    716-845-3221    Jens.Hillengass@roswellpark.org   
Principal Investigator: Jens Hillengass         
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
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Principal Investigator: Jens Hillengass Roswell Park Cancer Institute
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Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT03793907    
Other Study ID Numbers: i 70118
i 70118 ( Other Identifier: Roswell Park Cancer Institute )
First Posted: January 4, 2019    Key Record Dates
Last Update Posted: September 10, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases