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

NCT03793907 | Completed DMC

• 1 other identifier: i 70118
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Plasma Cell Myeloma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Adherence rate (Cohort 1)

  At 6 months

• Adherence rate (Cohort 2)

  At 6 months

Other Outcomes (10)

• Differences in lab parameters

  Before and after strength training program up to 1 year

• Clinical performance

  Before and after strength training program up to 1 year

• Physical activity level

  Before and after strength training program up to 1 year

Study Arms (2)

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.

Device: FitBit; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Behavioral: STEPS to Enhance Physical Activity

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.

Device: FitBit; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Resistance Training

Interventions

FitBit DEVICE

Wear Fitbit

Cohort 1 (strength training); Cohort 2 (walking program)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Cohort 1 (strength training); Cohort 2 (walking program)

Questionnaire Administration OTHER

Ancillary studies

Cohort 1 (strength training); Cohort 2 (walking program)

Resistance Training OTHER

Complete strength training

Also known as: Strength Training

Cohort 1 (strength training)

STEPS to Enhance Physical Activity BEHAVIORAL

Complete a walking program

Also known as: STEPS, STEPS Intervention, STEPS to Enhance Physical Activity (STEPS)

Cohort 2 (walking program)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jens Hillengass

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2018
• First Posted: January 4, 2019
• Study Start: December 17, 2019
• Primary Completion: February 28, 2022
• Study Completion: November 10, 2022
• Last Updated: April 10, 2023

Record last verified: 2023-04

Locations

US (1)