Clinical trial NCT04100044: Exercise Prescription for the Improvement of Quality of Life in Elderly Patients With Multiple Myeloma
Official title: A Pilot Study to Assess Adherence of an Exercise Prescription in Elderly Multiple Myeloma Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Plasma Cell Myeloma
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2019-09-23
Enrollment: 9
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Physical activity adherence
timeFrame: Up to 6 months
measure: Retention
timeFrame: Up to 6 months
Secondary outcomes:
measure: Change in short physical performance battery protocol
timeFrame: Baseline up to 6 months
measure: Change in 6 minute walk test
timeFrame: Baseline up to 6 months
measure: Change in grip strength
timeFrame: Baseline up to 6 months
measure: Change in Mini-Balance Evaluation Systems Test
timeFrame: Baseline up to 6 months
measure: Change in frailty score
timeFrame: Baseline up to 6 months
Other outcomes:
measure: Change in bone metabolism markers
timeFrame: Baseline up to 6 months
measure: Change in pain level
timeFrame: Baseline up to 6 months
measure: Change in quality of life (QOL)
timeFrame: Baseline up to 6 months
measure: Participant satisfaction
timeFrame: At 6 months
Locations:
city: Philadelphia
country: United States
facility: Sidney Kimmel Cancer Center at Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Sidney Kimmel Cancer Center at Thomas Jefferson University
name: Adam Binder, MD
role: PRINCIPAL_INVESTIGATOR
References: