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

Primary Purpose

Plasma Cell Myeloma

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise Counseling
Exercise Intervention
Questionnaire administration
Quality-of-Life Assessment
Sponsored by
Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Plasma Cell Myeloma

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Sidney Kimmel Cancer Center at Thomas Jefferson University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Health Services Research (physical therapist, exercise)

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in short physical performance battery protocol
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 6 minute walk test
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 grip strength
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 Mini-Balance Evaluation Systems Test
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
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.

Full Information

First Posted
September 4, 2019
Last Updated
April 7, 2022
Sponsor
Thomas Jefferson University
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1. Study Identification

Unique Protocol Identification Number
NCT04100044
Brief Title
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

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 24, 2019 (Actual)
Primary Completion Date
July 30, 2022 (Anticipated)
Study Completion Date
July 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thomas Jefferson University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plasma Cell Myeloma

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Health Services Research (physical therapist, exercise)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise Counseling
Intervention Description
Meet with physical therapist
Intervention Type
Behavioral
Intervention Name(s)
Exercise Intervention
Intervention Description
Receive personalized home exercise intervention
Intervention Type
Other
Intervention Name(s)
Questionnaire administration
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Physical activity adherence
Description
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%.
Time Frame
Up to 6 months
Title
Retention
Description
Will be measured by percent number of days the patient wears the provided FitBit during the 6-month period.
Time Frame
Up to 6 months
Secondary Outcome Measure Information:
Title
Change in short physical performance battery protocol
Description
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.
Time Frame
Baseline up to 6 months
Title
Change in 6 minute walk test
Description
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.
Time Frame
Baseline up to 6 months
Title
Change in grip strength
Description
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.
Time Frame
Baseline up to 6 months
Title
Change in Mini-Balance Evaluation Systems Test
Description
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.
Time Frame
Baseline up to 6 months
Title
Change in frailty score
Description
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.
Time Frame
Baseline up to 6 months
Other Pre-specified Outcome Measures:
Title
Change in bone metabolism markers
Description
Will include bone specific alkaline phosphatase, tartrate resistant acid phosphatase, C-terminal telopeptide fragment of type 1 collagen, and metabolomics signatures. Will trend metabolomics signatures as described above over time for individual participants and relate them to exercise adherence. Samples will be randomized in order to avoid machine drifts. All measurements will be carried out at least in triplicate and the false discovery rate will be used for hypothesis testing to determine the rate of type I errors when conducting multiple comparisons.
Time Frame
Baseline up to 6 months
Title
Change in pain level
Description
Will be measured by Brief Pain Inventory. There are 9 total questions consisting of: 1 diagram, 1 yes/no, 1 item to list pain medications/treatments, 5 questions with an 11-point rating scale, and one question with sub-items A-G with an 11-point rating scale for each sub-item. Scored as follows: Pain Severity Score = Mean of items 3-6 (pain at its worst, pain at its least, average Pain Interference Score = Mean of items 9A-9G (interference of pain with: general activity, mood, walking, normal work, relations, sleep, enjoyment of life).
Time Frame
Baseline up to 6 months
Title
Change in quality of life (QOL)
Description
Will be measured by European Organization of Research and Treatment of Cancer - QOL survey. There are 20 questions on a 4 point scale. Scores range from 0 to 100.
Time Frame
Baseline up to 6 months
Title
Participant satisfaction
Description
This is an 8 question survey with likert scale answers. Will be measured by a participant satisfaction questionnaire as well as open feedback questions to guide future studies.
Time Frame
At 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam Binder, MD
Organizational Affiliation
Sidney Kimmel Cancer Center at Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sidney Kimmel Cancer Center at Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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