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

NCT ID: NCT04100044

Last Updated: 2025-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-24
• Study Completion Date: 2022-05-27

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.

Conditions

Plasma Cell Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Health Services Research (physical therapist, exercise)

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.

Group Type: EXPERIMENTAL

Exercise Counseling

Intervention Type: OTHER

Meet with physical therapist

Exercise Intervention

Intervention Type: BEHAVIORAL

Receive personalized home exercise intervention

Questionnaire administration

Intervention Type: OTHER

Ancillary studies

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

Interventions

Exercise Counseling

Meet with physical therapist

Intervention Type: OTHER

Exercise Intervention

Receive personalized home exercise intervention

Intervention Type: BEHAVIORAL

Questionnaire administration

Ancillary studies

Intervention Type: OTHER

Quality-of-Life Assessment

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

Quality of Life Assessment

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adam Binder, MD

Role: PRINCIPAL_INVESTIGATOR

Sidney Kimmel Cancer Center at Thomas Jefferson University

Locations

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

JT 13791

Identifier Type: OTHER

Identifier Source: secondary_id

19G.514

Identifier Type: -

Identifier Source: org_study_id