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

NCT ID: NCT05142371

Last Updated: 2025-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-06
• Study Completion Date: 2025-03-28

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.

Detailed Description

PRIMARY OBJECTIVE:

I. Determine the effects of an 8-week telehealth exercise intervention on physical function as assessed by the Short Physical Performance Battery (SPPB) test (Aim 1)

SECONDARY OBJECTIVES:

I. Determine the effects of an 8-week telehealth exercise intervention as assessed using a 5-scale frailty index: body mass index (self-report), tiredness (questionnaire), level of physical activity (self-report), gait speed (sensors), and muscular strength (hand grip dynamometer) (Aim 2).

II. Determine the sustainability of the intervention on physical function and frailty at week 17 (Aim 3).

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: 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.

ARM B: 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.

Conditions

Plasma Cell Myeloma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Arm A (home-based exercise program)

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.

Group Type: EXPERIMENTAL

Exercise Intervention

Intervention Type: OTHER

Participate in exercise intervention

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

Questionnaire Administration

Intervention Type: OTHER

Complete questionnaires

Arm B (current activities)

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.

Group Type: ACTIVE_COMPARATOR

Best Practice

Intervention Type: OTHER

Continue current activities of daily living

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

Questionnaire Administration

Intervention Type: OTHER

Complete questionnaires

Interventions

Best Practice

Continue current activities of daily living

Intervention Type: OTHER

Exercise Intervention

Participate in exercise intervention

Intervention Type: OTHER

Quality-of-Life Assessment

Ancillary studies

Intervention Type: OTHER

Questionnaire Administration

Complete questionnaires

Intervention Type: OTHER

Other Intervention Names

standard of care; standard therapy; Quality of Life Assessment

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

City of Hope Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kyuwan Lee

Role: PRINCIPAL_INVESTIGATOR

City of Hope Comprehensive Cancer Center

Locations

City of Hope Medical Center

Duarte, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36329525 (View on PubMed)

Other Identifiers

NCI-2021-11000

Identifier Type: REGISTRY

Identifier Source: secondary_id

21406

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA033572

Identifier Type: NIH

Identifier Source: secondary_id

View Link

21406

Identifier Type: -

Identifier Source: org_study_id