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

Plasma Cell Myeloma Clinical Trial

Official title:

Effects of an 8-Week Telehealth Exercise Intervention to Improve Physical Function and Frailty in Multiple Myeloma Survivors

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05142371
• Other study ID #: 21406
• Secondary ID: NCI-2021-1100021
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 6, 2021
• Est. completion date: April 4, 2025

Study information

• Verified date: June 2024
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 33
• Est. completion date: April 4, 2025
• Est. primary completion date: April 4, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Frailty
• Multiple Myeloma
• Neoplasms, Plasma Cell
• Plasma Cell Myeloma

Intervention

Other:
• Best Practice
Continue current activities of daily living
• Exercise Intervention
Participate in exercise intervention
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Complete questionnaires

Locations

Country	Name	City	State
United States	City of Hope Medical Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical function	Assessed by the Short Physical Performance Battery (SPPB) test.	Up to 8 weeks
Secondary	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).	Up to 8 weeks