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

Not Applicable

Completed

• Conditions: Plasma Cell Myeloma
• Interventions: Other: Exercise Counseling; Behavioral: Exercise Intervention; Other: Questionnaire administration; Other: Quality-of-Life Assessment

• Registration Number: NCT04100044
• Lead Sponsor: Thomas Jefferson University

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.

Detailed Description

PRIMARY OBJECTIVE:

I. Assess the ability for elderly multiple myeloma patients to maintain a personalized exercise regimen and activity level for a period of 6 months.

SECONDARY OBJECTIVE:

I. Assess changes in biometric data.

EXPLORATORY OBJECTIVE I. Evaluate changes in bone metabolism markers as a result of exercise.

OUTLINE:

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.

After completion of study, patients are followed up every 6 months for 5 years.

Study Timeline

• Study First Submitted: 2019-09-04
• Study First Submitted QC: 2019-09-20
• Study First Posted: 2019-09-23
• Study Start: 2019-10-24
• Primary Completion: 2022-05-27
• Study Completion: 2022-05-27
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Health Services Research (physical therapist, exercise)	Exercise Counseling	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.
Health Services Research (physical therapist, exercise)	Questionnaire administration	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.
Health Services Research (physical therapist, exercise)	Quality-of-Life Assessment	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.
Health Services Research (physical therapist, exercise)	Exercise Intervention	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.

Primary Outcome Measures

Name	Time	Method
Retention	Up to 6 months	Will be measured by percent number of days the patient wears the provided FitBit during the 6-month period.
Physical activity adherence	Up to 6 months	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%.

Secondary Outcome Measures

Name	Time	Method
Change in grip strength	Baseline up to 6 months	Grip strength will be measured using a dynamometer, which gives results in kg of force. Will use methods for paired data to estimate the mean difference, along with a 95% confidence interval. Will carry out additional analyses to assess the change of these outcomes over time, utilizing the repeated measurements obtained at all timepoints. Will use mixed-effects regression for all analyses.
Change in frailty score	Baseline up to 6 months	Will use methods for paired data to estimate the mean difference, along with a 95% confidence interval. Will carry out additional analyses to assess the change of these outcomes over time, utilizing the repeated measurements obtained at all timepoints. Will use mixed-effects regression for all analyses.
Change in 6 minute walk test	Baseline up to 6 months	Will use methods for paired data to estimate the mean difference, along with a 95% confidence interval. Will carry out additional analyses to assess the change of these outcomes over time, utilizing the repeated measurements obtained at all timepoints. Will use mixed-effects regression for all analyses.
Change in short physical performance battery protocol	Baseline up to 6 months	The Short Physical Performance Battery Protocol is a test consisting of three sections (Balance, Gait Speed, and Chair Stand). The score for the Short Physical Performance Battery Protocol is scored as a total of the points earned in each section. Scores range from a total of 0 to 12 points.; Will use methods for paired data to estimate the mean difference, along with a 95% confidence interval. Will carry out additional analyses to assess the change of these outcomes over time, utilizing the repeated measurements obtained at all timepoints. Will use mixed-effects regression for all analyses.
Change in Mini-Balance Evaluation Systems Test	Baseline up to 6 months	Will use methods for paired data to estimate the mean difference, along with a 95% confidence interval. Will carry out additional analyses to assess the change of these outcomes over time, utilizing the repeated measurements obtained at all timepoints. Will use mixed-effects regression for all analyses.

Trial Locations

Locations (1)

Sidney Kimmel Cancer Center at Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States