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

Feasibility of Strength Training and Impact on Pain and Quality of Life in Patients With Multiple Myeloma

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.

Study Overview

• Status: Completed
• Conditions: Plasma Cell Myeloma
• Intervention / Treatment: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Device: FitBit; Behavioral: STEPS to Enhance Physical Activity; Other: Resistance Training

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.

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.	Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Device: FitBit; Wear Fitbit; 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.	Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Device: FitBit; Wear Fitbit; Other: Resistance Training; Complete strength training; Other Names: Strength Training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Other Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Roswell Park Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2019
• Primary Completion (Actual): February 28, 2022
• Study Completion (Actual): November 10, 2022

Study Registration Dates

• First Submitted: December 28, 2018
• First Submitted That Met QC Criteria: January 2, 2019
• First Posted (Actual): January 4, 2019

Study Record Updates

• Last Update Posted (Actual): April 10, 2023
• Last Update Submitted That Met QC Criteria: April 7, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell
• Other Study ID Numbers: i 70118 (Other Identifier: Roswell Park Cancer Institute)

Drug and device information, study documents

• 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