An interventional study of Exercise Counseling and Exercise Intervention in Plasma Cell Myeloma, sponsored by Thomas Jefferson University. Completed at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-04-29.
Sponsored by Thomas Jefferson University · Not applicable, Interventional, and Health services research
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.
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.
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
This study's enrollment of 9 is below the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Thomas Jefferson University is the lead sponsor of 384 studies on the registry; 71 are open to participants now.
Of its 44 completed or terminated interventional studies of FDA-regulated products, 20 (45%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients are eligible whether or not they have lytic bone lesions
Exclusion Criteria:
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.
Other: Exercise Counseling · Behavioral: Exercise Intervention · Other: Questionnaire administration · Other: Quality-of-Life Assessment
Meet with physical therapist
Receive personalized home exercise intervention
Ancillary studies
Ancillary studies
Also known as: Quality of Life Assessment
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%.
Time frame: Up to 6 months
Retention
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
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.
Time frame: Baseline up to 6 months
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.
Time frame: Baseline up to 6 months
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.
Time frame: Baseline up to 6 months
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.
Time frame: Baseline up to 6 months
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.
Time frame: Baseline up to 6 months
Change in bone metabolism markers
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
Change in pain level
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
Change in quality of life (QOL)
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
Participant satisfaction
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
Plan to share: No
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This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Thomas Jefferson University