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

Thomas Jefferson University

Status

Completed

Conditions

Plasma Cell Myeloma

Treatments

Other: Quality-of-Life Assessment

Behavioral: Exercise Intervention

Other: Questionnaire administration

Other: Exercise Counseling

Study type

Interventional

Funder types

Other

Identifiers

NCT04100044

JT 13791 (Other Identifier)

19G.514

Details and patient eligibility

About

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.

Full 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.

Enrollment

9 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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