Telehealth Exercise Intervention to Improve Physical Function and Frailty in Multiple Myeloma Survivors

NCT05142371 | Completed DMC

• 3 other identifiers: 21406NCI-2021-11000P30CA033572
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial examines a telehealth exercise intervention in improving physical function and frailty in multiple myeloma survivors. The exercise program uses a telehealth platform (delivered by smart phones, tablets, or computers) to view pre-recorded exercise videos on coordination, posture, stretching, balance, and resistance/aerobic (cardio) training. Frailty includes being underweight, slow walking speed, exhaustion, low physical activity, and weakness. Participating in an exercise program may help improve patient's physical function and strength.

Conditions

Plasma Cell Myeloma

Outcome Measures

Primary Outcomes (1)

• Physical function

  Assessed by the Short Physical Performance Battery (SPPB) test.

  Up to 8 weeks

Secondary Outcomes (1)

• Frailty index

  Up to 8 weeks

Study Arms (2)

Arm A (home-based exercise program)

EXPERIMENTAL

Patients undergo home-based exercise program 3 times per week for 8 weeks. Patients complete questionnaires at baseline (before 1 week) and at weeks 9 and 17.

Other: Exercise Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Arm B (current activities)

ACTIVE COMPARATOR

Patients complete questionnaires at baseline and at week 9 and 17. Patients continue maintaining current activities of daily living and do not participate in any exercise program. Patients may then participate in home-based exercise program 3 times per week for 8 weeks.

Other: Best Practice; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Best Practice OTHER

Continue current activities of daily living

Also known as: standard of care, standard therapy

Arm B (current activities)

Exercise Intervention OTHER

Participate in exercise intervention

Arm A (home-based exercise program)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm A (home-based exercise program); Arm B (current activities)

Questionnaire Administration OTHER

Complete questionnaires

Arm A (home-based exercise program); Arm B (current activities)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with multiple myeloma
• \>= 18 years old
• Self-reported as pre-frail or frail (i.e. Fried Criteria: clinically underweight and exhibiting exhaustion, low energy expenditure, slow walking speed, and muscle weakness), with the presence of 2/5 indices classified as pre-frail and \>= 3/5 indices classified as frail
• Has undergone autologous stem cell transplant (ASCT) within 30 and 180 days prior to registration
• Physically able and willing to complete all study procedures
• English-speaking

You may not qualify if:

• Have clinically significant/active cardiovascular disease (e.g. unstable angina, uncontrolled arrhythmia, etc.)
• Have contraindications to exercise (acute infectious disease or unstable bone lesions)
• Currently recovering from a recent injury or have been physically injured in the past 6 months, in which participation in rigorous exercise may not be appropriate
• Participate in regular, structured exercise (\> 60 minutes/week)
• Female patients who are pregnant or planning to become pregnant

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

Related Publications (1)

• Lee K, Nathwani N, Shamunee J, Lindenfeld L, Wong FL, Krishnan A, Armenian S. Telehealth exercise to Improve Physical function and frailty in patients with multiple myeloma treated with autologous hematopoietic Stem cell transplantation (TIPS): protocol of a randomized controlled trial. Trials. 2022 Nov 3;23(1):921. doi: 10.1186/s13063-022-06848-y.

  PMID: 36329525 DERIVED

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Practice Guidelines as Topic; Standard of Care

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care

Study Officials

• Kyuwan Lee

  City of Hope Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2021
• First Posted: December 2, 2021
• Study Start: October 6, 2021
• Primary Completion: March 28, 2025
• Study Completion: March 28, 2025
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: beginning 9 months and ending 36 months following article publicatio
• Access Criteria: * Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. * For individual participant data meta-analysis * Proposal may be submitted up to 36 months following article publication.

Locations

US (1)