Clinical trial NCT04484714: Virtual Exercise for Multiple Myeloma
Official title: Feasibility of a Virtually Supported Home-Based Resistance and Aerobic Exercise Program for Cancer Survivors With Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Myeloma
Keywords: exercise
pilot
feasibility
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2020-07-23
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group before and after
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. 18 years of age and older
2. Diagnosis of multiple myeloma
3. 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
4. Able to provide informed written consent in English
5. Approved for physical activity participation by their oncologist and cleared for physical activity by the Certified Exercise Physiologist on the PAR-Q+

Exclusion Criteria:

1. Unstable cardiac/metabolic condition that would be deemed unsafe to exercise
2. Severe anemia
3. Spinal instability requiring surgical intervention
4. AL amyloidosis, solitary plasmacytoma, or Waldenstrom macroglobulinemia
5. 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).
6. Inability to provide consent
7. Inability to commit to, and/or comply with the intervention due to personal reasons (e.g. vacation planned during the intervention period)

Primary outcomes:
measure: Feasibility (Adherence)
timeFrame: 12 weeks
Secondary outcomes:
measure: Feasibility (Recruitment rate)
timeFrame: 7 months
measure: Feasibility (Completion rate)
timeFrame: 12 weeks
measure: Feasibility (Safety)
timeFrame: 12 weeks
Other outcomes:
measure: Home-based Stepping Test
timeFrame: Change from baseline to 12 weeks
measure: Shoulder flexibility
timeFrame: Change from baseline to 12 weeks
measure: Lower Body Flexibility
timeFrame: Change from baseline to 12 weeks
measure: Leg Strength
timeFrame: Change from baseline to 12 weeks
measure: Balance
timeFrame: Change from baseline to 12 weeks
measure: Balance Confidence
timeFrame: Change from baseline to 12 weeks
measure: Upper Extremity Function
timeFrame: Change from baseline to 12 weeks
measure: Lower Extremity Function
timeFrame: Change from baseline to 12 weeks
measure: Cancer-Specific Quality of Life
timeFrame: Change from baseline to 12 weeks
measure: Fatigue
timeFrame: Change from baseline to 12 weeks
measure: Six-minute walk test (optional)
timeFrame: Change from baseline to 12 weeks
measure: Upper Extremity Grip Strength (optional)
timeFrame: Change from baseline to 12 weeks
measure: Upper extremity strength (optional)
timeFrame: Change from baseline to 12 weeks
measure: Lower extremity strength (optional)
timeFrame: Change from baseline to 12 weeks
measure: Core Endurance (optional)
timeFrame: Change from baseline to 12 weeks
measure: Fall risk (optional)
timeFrame: Change from baseline to 12 weeks
Locations:
city: Edmonton
country: Canada
facility: University of Alberta/ Cross Cancer Institute
state: Alberta
Study officials:
References: