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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility (Adherence) | The percentage of total exercise dose prescribed that was actually completed (%) | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 7 months |
| Feasibility (Completion rate) |
| Measure | Description | Time Frame |
|---|---|---|
| Home-based Stepping Test | Change in 2-minute stepping test (number of steps) | Change from baseline to 12 weeks |
| Shoulder flexibility | Change in active shoulder flexion range of motion (degrees) |
Inclusion Criteria:
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+
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alberta/ Cross Cancer Institute | Edmonton | Alberta | T6G 2G4 | Canada |
No plan in place at this time
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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Single group before and after
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|
The number of participants who completed the program and follow-up assessment out of the number of participants who consented to the study |
| 12 weeks |
| Feasibility (Safety) | The number of adverse events reported by the participants during program participation, including the 12-week program and fitness assessments | 12 weeks |
| Change from baseline to 12 weeks |
| Lower Body Flexibility | Change in sit-and-reach test (cm) | Change from baseline to 12 weeks |
| Leg Strength | Change in 30-second sit-to-stand (number of repetitions) | Change from baseline to 12 weeks |
| Balance | Change in one legged stance test (seconds | Change from baseline to 12 weeks |
| Balance Confidence | Activities-specific Balance Confidence (ABC) scale (score) | Change from baseline to 12 weeks |
| Upper Extremity Function | Change in Upper Extremity Functional Index (score) | Change from baseline to 12 weeks |
| Lower Extremity Function | Change in Lower Extremity Functional Scale (score) | Change from baseline to 12 weeks |
| Cancer-Specific Quality of Life | Change in Functional Assessment of Cancer Therapy General, Multiple Myeloma, and Bone Pain Scales (score) | Change from baseline to 12 weeks |
| Fatigue | Change in FACIT-Fatigue Subscale (score) | Change from baseline to 12 weeks |
| Six-minute walk test (optional) | Six-minute walk test distance (metres) | Change from baseline to 12 weeks |
| Upper Extremity Grip Strength (optional) | Hand-grip dynamometry (kg) | Change from baseline to 12 weeks |
| Upper extremity strength (optional) | One repetition maximum bench press (kg) | Change from baseline to 12 weeks |
| Lower extremity strength (optional) | One repetition maximum leg press (kg) | Change from baseline to 12 weeks |
| Core Endurance (optional) | Plank hold (seconds) | Change from baseline to 12 weeks |
| Fall risk (optional) | Three-metre backwards walk test (seconds) | Change from baseline to 12 weeks |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D001519 | Behavior |