Plasma Cell MyelomaNCT05142371
Telehealth Exercise Intervention to Improve Physical Function and Frailty in Multiple Myeloma Survivors
A study testing Best Practice, Exercise Intervention and Quality-of-Life Assessment in people with Plasma Cell Myeloma, run by City of Hope Medical Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plasma Cell Myeloma
- What is being tested?
- Best Practice, Exercise Intervention and Quality-of-Life Assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2021to 28 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010
About this study
Official title: Effects of an 8-Week Telehealth Exercise Intervention to Improve Physical Function and Frailty in Multiple Myeloma Survivors
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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
- Being tested
- Best Practice, Exercise Intervention, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Continue current activities of daily living
Participate in exercise intervention
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Complete questionnaires
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Best Practice; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical function
Assessed by the Short Physical Performance Battery (SPPB) test.
Measured: Up to 8 weeks
Secondary outcomes (1)
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).
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start6 Oct 2021
- Primary completion28 Mar 2025
- Study completion28 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Plasma Cell MyelomaStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Kyuwan Lee, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05142371
- Sponsor's protocol ID
- 21406
- Other IDs
- NCI-2021-11000, 21406, P30CA033572
- Status last verified
- May 2025
- First submitted
- 29 Oct 2021
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Publications
Lee K, Shamunee J, Lee H, Du X, Lindenfeld L, Krishnan A, Nathwani N, Wong FL, Armenian S. mHealth-Supported Exercise Rehabilitation to Reverse Frailty After Autologous Transplantation in Multiple Myeloma: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2026 May 21;14:e87628. doi: 10.2196/87628.
PubMed 42166768Lee 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.
PubMed 36329525
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an 8-Week Telehealth Exercise Intervention to Improve Physical Function and Frailty in Multiple Myeloma Survivors
- ClinicalTrials.gov ID
- NCT05142371
- Acronym / sponsor ID
- 21406
- Conditions
- Plasma Cell Myeloma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 6 Oct 2021 (actual)
- Primary completion
- 28 Mar 2025 (actual)
- Study completion
- 28 Mar 2025 (actual)
- First posted
- 2 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (home-based exercise program) | Experimental | Other: Exercise Intervention, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients 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 (current activities) | Active comparator | Other: Best Practice, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyContinue current activities of daily living | Other | Arm B (current activities) |
| Exercise InterventionParticipate in exercise intervention | Other | Arm A (home-based exercise program) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm A (home-based exercise program), Arm B (current activities) |
| Questionnaire AdministrationComplete questionnaires | Other | Arm A (home-based exercise program), Arm B (current activities) |
Primary outcome
Physical function
Time frame: Up to 8 weeks
Assessed by the Short Physical Performance Battery (SPPB) test.
1 secondary outcome
Frailty index
Time frame: Up to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Derived from this study: PubMed 42166768Lee K, Shamunee J, Lee H, Du X, Lindenfeld L, Krishnan A, Nathwani N, Wong FL, Armenian S. mHealth-Supported Exercise Rehabilitation to Reverse Frailty After Autologous Transplantation in Multiple Myeloma: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2026 May 21;14:e87628. doi: 10.2196/87628.
- Derived from this study: PubMed 36329525Lee 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.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyuwan Lee principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice, Exercise Intervention and Quality-of-Life Assessment in people with Plasma Cell Myeloma, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical function (time frame: Up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05142371, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.