Multiple MyelomaMY-PROGRESSNCT04484714
Virtual Exercise for Multiple Myeloma
A study testing Exercise in people with Multiple Myeloma, run by University of Alberta at 1 site in Canada.
Trial summary
The primary objective of this pilot study is to determine the safety and feasibility a 12-week virtually supported home-based aerobic and resistance exercise program progressing cancer survivors with Multiple Myeloma to meet standards identified in the 2019 Exercise Guidelines for Cancer Survivors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteCanada
- Study dates
- 15 Sep 2020to 31 Aug 2021
- 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
- 18 years of age and older
- Diagnosis of multiple myeloma
- In one of the following three treatment categories:
- Transplant ineligible patients, currently in first line treatment
- Transplant eligible patients, sufficiently recovered from transplantation (>3 months following transplantation)
- Patients with relapsed/recurrent myeloma with either 1-3 prior lines of treatment or 4+ prior lines
- Able to provide informed written consent in English
- Approved for physical activity participation by their oncologist and cleared for physical activity by the Certified Exercise Physiologist on the PAR-Q+
Who cannot join
- Unstable cardiac/metabolic condition that would be deemed unsafe to exercise
- Severe anemia
- Spinal instability requiring surgical intervention
- AL amyloidosis, solitary plasmacytoma, or Waldenstrom macroglobulinemia
- Too frail to participate in home exercise, as determine by baseline physical assessment (i.e., unable to complete a single sit-to-stand or balance on one foot for ≥ 3 seconds).
- Inability to provide consent
- Inability to commit to, and/or comply with the intervention due to personal reasons (e.g. vacation planned during the intervention period)
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Alberta/ Cross Cancer Institute
Edmonton, Alberta, T6G 2G4
About this study
Official title: Feasibility of a Virtually Supported Home-Based Resistance and Aerobic Exercise Program for Cancer Survivors With Multiple Myeloma
The primary objective of this pilot study is to determine the safety and feasibility a 12-week virtually supported home-based aerobic and resistance exercise program progressing cancer survivors with Multiple Myeloma to meet standards identified in the 2019 Exercise Guidelines for Cancer Survivors.
The protocol will be measuring recruitment, adherence, completion, cost tracking, as well as fitness and quality of life outcomes. The study will be a single-group prospective before and after study that will help inform a future larger-scale project. We will aim to recruit 25 participants.
Read more
The Health Research Ethics Board of Alberta Cancer Committee will approve this study. Participants will participate in a combined resistance and aerobic exercise program biweekly for 12 weeks. Exercise sessions will be supported and progressive in nature, between 40 and 75 minutes each.
Analyses: fitness testing and quality of life scales will be administered before and after the intervention. Scores will be compared to evaluate changes over the course of the intervention. Safety and feasibility information will be collected throughout the study and evaluated to determine program feasibility. Program satisfaction will be evaluated using a satisfaction survey.
Read the detailed description
Multiple myeloma (MM), a cancer of the plasma cells in bone marrow, is associated with osteolytic bone destruction, leading to deformities, chronic pain, reduced mobility and functioning, fatigue, and risk of fracture. Although incurable, newly developed therapies are extending survival, but some with significant side-effects. Patients may be living longer but with lasting, debilitating side-effects.
Exercise has been proposed as a way to optimize patient function and quality of life in the face of lasting symptom burden. However, current evidence-informed exercise guidelines for cancer survivors may not be appropriate for those with bone fragility, including those with MM, as they are based on findings from studies in breast and prostate cancers. In MM specifically, the literature presents mixed results, and several studies have limited generalizability, reproducibility, or were underdosed.
The main objective of this study is to determine the safety and feasibility of a 12-week virtually supported home-based aerobic and resistance exercise program that aims to progress individuals to the 2019 Exercise Guidelines for Cancer Survivors in a sample of cancer survivors with multiple myeloma, as defined by:
- Recruitment rate: ≥ 21 participants consenting to the study over a 7-month recruitment period (primary endpoint)
- Completion rate: ≥ 80% of participants consenting to the study complete the 12-week assessment
- Safety: no increase in the rate of bony events above those estimated to occur in the target population
- Adherence: average completion of ≥ 75% of the exercise prescription amongst participants
We will aim to recruit 25 participants from clinics at the local cancer hospital, the local disease-group support society, and from the currently accruing Alberta Cancer Exercise program. Subjects will be screened for eligibility and if they meet all eligibility criteria, an information letter of the study will be provided, and they will be asked to contact the investigators if interested in taking part in the study. All participants will be required to provide written informed consent as per the Health Research Ethics Board of Alberta: Cancer Committee (HREBA).
Participants will participate in a 12-week virtually supported home-based aerobic and resistance exercise program, twice weekly using the Heal-Me application. Sessions will be completed as virtual live classes or supported follow-along independent home workouts. Sessions will progress in duration and difficulty over the course of the program, aiming to have participants meet the 2019 Exercise Guidelines for Cancer Survivors by the end of the program. Each session will include aerobic exercise (i.e. walking, cycling, or cardio circuit), and a full-body resistance training routine using free weights, body weight exercises, and/or bands, followed by balance and stretching exercises.
Analyses: Demographic and medical information will be presented using median and range and percentage for interval and nominal data, respectively. Descriptive statistics (mean ± SD and frequencies) will be used to report safety and feasibility measures. Adherence will be tracked as the percentage of total training load prescribed that was actually completed. Wilcoxon Signed Rank Tests will be used to compare and pre- and post-intervention fitness assessment and quality of life scores. All analyses will be conducted using Stata/MP (version 13.0, StataCorp LLC, College Station, TX), with alpha set to 0.05.
- Conditions
- Multiple Myeloma
- Being tested
- Exercise
- Keywords
- exercise, pilot, feasibility
- Medical subject headings
- Multiple Myeloma, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Participants will participate in a 12-week virtually supported home-based aerobic and resistance exercise program, twice weekly using the Heal-Me application. Sessions will be completed as virtual live classes or supported follow-along independent home workouts. Sessions will progress in duration and difficulty over the course of the program, aiming to have participants meet the 2019 Exercise Guidelines for Cancer Survivors by the end of the program. Each session will include aerobic exercise (i.e. walking, cycling, or cardio circuit), and a full-body resistance training routine using free weights, body weight exercises, and/or bands, followed by balance and stretching exercises.
| Study group | Role | What they receive |
|---|---|---|
| Behavioural: Exercise | Experimental | Participants will take part in a twelve week resistance and aerobic exercise program twice per week delivered virtually.
Exercise sessions will include a combination of aerobic, resistance, balance, and flexibility exercises Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility (Adherence)
The percentage of total exercise dose prescribed that was actually completed (%)
Measured: 12 weeks
Secondary outcomes (3)
Feasibility (Recruitment rate)
The number of participants recruited per month over the recruitment period and the proportion of patients who participate in the study, out of the total number of eligible patients
Measured: 7 months
Feasibility (Completion rate)
The number of participants who completed the program and follow-up assessment out of the number of participants who consented to the study
Measured: 12 weeks
Feasibility (Safety)
The number of adverse events reported by the participants during program participation, including the 12-week program and fitness assessments
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start15 Sep 2020
- Primary completion15 Jun 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single group before and after
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04484714
- Sponsor's protocol ID
- HREBA.CC-20-0201
- Acronym
- MY-PROGRESS
- Status last verified
- Sep 2021
- First submitted
- 21 Jul 2020
- Last updated
- 17 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: No plan in place at this time
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Virtually Supported Home-Based Resistance and Aerobic Exercise Program for Cancer Survivors With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT04484714
- Acronym / sponsor ID
- MY-PROGRESS / HREBA.CC-20-0201
- Conditions
- Multiple Myeloma
- Keywords
- exercise, pilot, feasibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 23 Jul 2020 (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.
The primary objective of this pilot study is to determine the safety and feasibility a 12-week virtually supported home-based aerobic and resistance exercise program progressing cancer survivors with Multiple Myeloma to meet standards identified in the 2019 Exercise Guidelines for Cancer Survivors.
The protocol will be measuring recruitment, adherence, completion, cost tracking, as well as fitness and quality of life outcomes. The study will be a single-group prospective before and after study that will help inform a future larger-scale project. We will aim to recruit 25 participants.
The Health Research Ethics Board of Alberta Cancer Committee will approve this study. Participants will participate in a combined resistance and aerobic exercise program biweekly for 12 weeks. Exercise sessions will be supported and progressive in nature, between 40 and 75 minutes each.
Analyses: fitness testing and quality of life scales will be administered before and after the intervention. Scores will be compared to evaluate changes over the course of the intervention. Safety and feasibility information will be collected throughout the study and evaluated to determine program feasibility. Program satisfaction will be evaluated using a satisfaction survey.
Detailed description
Multiple myeloma (MM), a cancer of the plasma cells in bone marrow, is associated with osteolytic bone destruction, leading to deformities, chronic pain, reduced mobility and functioning, fatigue, and risk of fracture. Although incurable, newly developed therapies are extending survival, but some with significant side-effects. Patients may be living longer but with lasting, debilitating side-effects.
Exercise has been proposed as a way to optimize patient function and quality of life in the face of lasting symptom burden. However, current evidence-informed exercise guidelines for cancer survivors may not be appropriate for those with bone fragility, including those with MM, as they are based on findings from studies in breast and prostate cancers. In MM specifically, the literature presents mixed results, and several studies have limited generalizability, reproducibility, or were underdosed.
The main objective of this study is to determine the safety and feasibility of a 12-week virtually supported home-based aerobic and resistance exercise program that aims to progress individuals to the 2019 Exercise Guidelines for Cancer Survivors in a sample of cancer survivors with multiple myeloma, as defined by:
- Recruitment rate: ≥ 21 participants consenting to the study over a 7-month recruitment period (primary endpoint)
- Completion rate: ≥ 80% of participants consenting to the study complete the 12-week assessment
- Safety: no increase in the rate of bony events above those estimated to occur in the target population
- Adherence: average completion of ≥ 75% of the exercise prescription amongst participants
We will aim to recruit 25 participants from clinics at the local cancer hospital, the local disease-group support society, and from the currently accruing Alberta Cancer Exercise program. Subjects will be screened for eligibility and if they meet all eligibility criteria, an information letter of the study will be provided, and they will be asked to contact the investigators if interested in taking part in the study. All participants will be required to provide written informed consent as per the Health Research Ethics Board of Alberta: Cancer Committee (HREBA).
Participants will participate in a 12-week virtually supported home-based aerobic and resistance exercise program, twice weekly using the Heal-Me application. Sessions will be completed as virtual live classes or supported follow-along independent home workouts. Sessions will progress in duration and difficulty over the course of the program, aiming to have participants meet the 2019 Exercise Guidelines for Cancer Survivors by the end of the program. Each session will include aerobic exercise (i.e. walking, cycling, or cardio circuit), and a full-body resistance training routine using free weights, body weight exercises, and/or bands, followed by balance and stretching exercises.
Analyses: Demographic and medical information will be presented using median and range and percentage for interval and nominal data, respectively. Descriptive statistics (mean ± SD and frequencies) will be used to report safety and feasibility measures. Adherence will be tracked as the percentage of total training load prescribed that was actually completed. Wilcoxon Signed Rank Tests will be used to compare and pre- and post-intervention fitness assessment and quality of life scores. All analyses will be conducted using Stata/MP (version 13.0, StataCorp LLC, College Station, TX), with alpha set to 0.05.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group before and after
| Arm | Type | Receives |
|---|---|---|
| Behavioural: Exercise | Experimental | Behavioral: ExerciseParticipants will take part in a twelve week resistance and aerobic exercise program twice per week delivered virtually. Exercise sessions will include a combination of aerobic, resistance, balance, and flexibility exercises |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 years of age and older
- Diagnosis of multiple myeloma
- In one of the following three treatment categories:
- Able to provide informed written consent in English
- Approved for physical activity participation by their oncologist and cleared for physical activity by the Certified Exercise Physiologist on the PAR-Q+
Key exclusion criteria (7 listed)
- Unstable cardiac/metabolic condition that would be deemed unsafe to exercise
- Severe anemia
- Spinal instability requiring surgical intervention
- AL amyloidosis, solitary plasmacytoma, or Waldenstrom macroglobulinemia
- Too frail to participate in home exercise, as determine by baseline physical assessment (i.e., unable to complete a single sit-to-stand or balance on one foot for ≥ 3 seconds).
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 |
|---|---|---|
| ExerciseParticipants will participate in a 12-week virtually supported home-based aerobic and resistance exercise program, twice weekly using the Heal-Me application. Sessions will be completed as virtual live classes or supported follow-along independent home workouts. Sessions will progress in duration and difficulty over the course of the program, aiming to have participants meet the 2019 Exercise Guidelines for Cancer Survivors by the end of the program. Each session will include aerobic exercise (i.e. walking, cycling, or cardio circuit), and a full-body resistance training routine using free weights, body weight exercises, and/or bands, followed by balance and stretching exercises. | Behavioural | Behavioural: Exercise |
Primary outcome
Feasibility (Adherence)
Time frame: 12 weeks
The percentage of total exercise dose prescribed that was actually completed (%)
3 secondary outcomes
Feasibility (Recruitment rate)
Time frame: 7 months
Feasibility (Completion rate)
Time frame: 12 weeks
Feasibility (Safety)
Time frame: 12 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 17 Sep 2021.
- Individual participant dataSharing planned: Undecided. No plan in place at this time
Related trials for Multiple Myeloma
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Not yet recruitingPhase 3
A Trial Comparing Ramantamig and Daratumumab (Ramantamig-D) Versus Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone in Participants With Newly Diagnosed Multiple Myeloma Who Are Transplant Eligible
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Autologous T Cells Transduced With Retroviral Vectors Expressing TCRs for Participant-specific Neoantigens in Patients With Hematologic Malignancies
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Multiple Myeloma, run by University of Alberta at 1 site in Canada.
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 8 inclusion and 7 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 17 Sep 2021. 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 Canada. 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?
Feasibility (Adherence) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Sep 2021.