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

Primary Purpose

Plasma Cell Myeloma

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Best Practice
Exercise Intervention
Quality-of-Life Assessment
Questionnaire Administration
Sponsored by
City of Hope Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Plasma Cell Myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • City of Hope Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A (home-based exercise program)

Arm B (current activities)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Frailty index
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).

Full Information

First Posted
October 29, 2021
Last Updated
September 20, 2023
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05142371
Brief Title
Telehealth Exercise Intervention to Improve Physical Function and Frailty in Multiple Myeloma Survivors
Official Title
Effects of an 8-Week Telehealth Exercise Intervention to Improve Physical Function and Frailty in Multiple Myeloma Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 6, 2021 (Actual)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

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
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A (home-based exercise program)
Arm Type
Experimental
Arm Description
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 Title
Arm B (current activities)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Best Practice
Other Intervention Name(s)
standard of care, standard therapy
Intervention Description
Continue current activities of daily living
Intervention Type
Other
Intervention Name(s)
Exercise Intervention
Intervention Description
Participate in exercise intervention
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Complete questionnaires
Primary Outcome Measure Information:
Title
Physical function
Description
Assessed by the Short Physical Performance Battery (SPPB) test.
Time Frame
Up to 8 weeks
Secondary Outcome Measure Information:
Title
Frailty index
Description
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).
Time Frame
Up to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyuwan Lee
Organizational Affiliation
City of Hope Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request, beginning 9 months and ending 36 months following article publication
IPD Sharing Time Frame
beginning 9 months and ending 36 months following article publicatio
IPD Sharing 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.
Citations:
PubMed Identifier
36329525
Citation
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.
Results Reference
derived

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

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