Exercise Prescription for the Improvement of Quality of Life in Elderly Patients With Multiple Myeloma

NCT04100044 | Completed DMC

• 2 other identifiers: 19G.514JT 13791
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

This trial studies how well exercise prescription works in improving quality of life in elderly patients with multiple myeloma. Engaging and adhering to an exercise program may improve functional status and quality of life and decrease pain and skeletal-related events. This study is being done to see if elderly patients with multiple myeloma can participate in a physical activity program.

Conditions

Plasma Cell Myeloma

Outcome Measures

Primary Outcomes (2)

• Physical activity adherence

  Will be measured at each assessment using an Actigraph tri-axial hip-worn accelerometers, worn for 7 days at each assessment point, supplemented with patient self-report of exercise in the past 7 days using a physical activity recall to differentiate subtypes of physical activity. Will estimate the proportion of participants who maintained their target level, along with an exact 95% confidence interval. We will use an exact binomial test to assess whether adherence exceeds 50%. Adherence to the exercise prescriptions will be measured with the absolute and relative increase from baseline in min/week of aerobic and resistance exercise at 3 months and 6 months (benchmark: min/week of exercise changes by \> 100% and a minimum of 90 min/week at 6 months). The percent of prescribed minutes of exercise performed at 3 and 6 months also will be calculated with goal of adherence greater than 50%.

  Up to 6 months

• Retention

  Will be measured by percent number of days the patient wears the provided FitBit during the 6-month period.

  Up to 6 months

Secondary Outcomes (5)

• Change in short physical performance battery protocol

  Baseline up to 6 months

• Change in 6 minute walk test

  Baseline up to 6 months

• Change in grip strength

  Baseline up to 6 months

• Change in Mini-Balance Evaluation Systems Test

  Baseline up to 6 months

• Change in frailty score

  Baseline up to 6 months

Other Outcomes (4)

• Change in bone metabolism markers

  Baseline up to 6 months

• Change in pain level

  Baseline up to 6 months

• Change in quality of life (QOL)

  Baseline up to 6 months

Study Arms (1)

Health Services Research (physical therapist, exercise)

EXPERIMENTAL

Patients meet with a physical therapist on day 0 and at 3 and 6 months and receive a personalized home exercise intervention consisting of aerobic and resistance training for 6 months. Patients also receive face-to-face sessions, video chats, or text message check-ins with physical therapist weekly for 6 weeks and then every other week for up to 24 weeks.

Other: Exercise Counseling; Behavioral: Exercise Intervention; Other: Questionnaire administration; Other: Quality-of-Life Assessment

Interventions

Exercise Counseling OTHER

Meet with physical therapist

Health Services Research (physical therapist, exercise)

Exercise Intervention BEHAVIORAL

Receive personalized home exercise intervention

Health Services Research (physical therapist, exercise)

Questionnaire administration OTHER

Ancillary studies

Health Services Research (physical therapist, exercise)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Health Services Research (physical therapist, exercise)

Eligibility Criteria

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

You may qualify if:

• Diagnosis of multiple myeloma
• If patients are undergoing an autologous stem cell transplant, then they will be enrolled after their transplant so that there is not an interruption in the study period
• Patients are eligible whether or not they have lytic bone lesions
• If they do have lytic lesions, the lesions must be low risk for fracture (low risk by Mirel's score or less than 50% of vertebral body height)
• If patients are high risk for bone fracture, they must undergo bone stabilization prior to being considered for enrollment
• Patients will have to be at least 6 weeks from date of stabilization
• Provide signed and dated informed consent form
• Willing to comply with all study procedures and be available for the duration of the study
• Subjects need to be within 24 months of their multiple myeloma diagnosis
• Subject must be able to stand and walk to perform baseline assessments
• Subjects must be able to text message (will need cell phone)
• Need to limit to able to read and understand English as video visit capability is only in English at this point in time and multiple questionnaires will not be translated into other languages

You may not qualify if:

• Presence of lytic lesions that cannot undergo appropriate stabilization
• Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study
• Non English speaking
• Diagnosed greater than 24 months prior to screening

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

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

Study Officials

• Adam Binder, MD

  Sidney Kimmel Cancer Center at Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2019
• First Posted: September 23, 2019
• Study Start: October 24, 2019
• Primary Completion: May 27, 2022
• Study Completion: May 27, 2022
• Last Updated: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)