Virtual Exercise for Multiple Myeloma

NCT04484714 | Completed

• 1 other identifier: HREBA.CC-20-0201
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma

Keywords

exercise; pilot; feasibility

Outcome Measures

Primary Outcomes (1)

• Feasibility (Adherence)

  The percentage of total exercise dose prescribed that was actually completed (%)

  12 weeks

Secondary Outcomes (3)

• Feasibility (Recruitment rate)

  7 months

• Feasibility (Completion rate)

  12 weeks

• Feasibility (Safety)

  12 weeks

Other Outcomes (16)

• Home-based Stepping Test

  Change from baseline to 12 weeks

• Shoulder flexibility

  Change from baseline to 12 weeks

• Lower Body Flexibility

  Change from baseline to 12 weeks

Study Arms (1)

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

Behavioral: Exercise

Interventions

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.

Behavioural: Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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+

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta/ Cross Cancer Institute

Edmonton, Alberta, T6G 2G4, Canada

Location

MeSH Terms

Conditions

Multiple Myeloma; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single group before and after

Study Record Dates

• First Submitted: July 21, 2020
• First Posted: July 23, 2020
• Study Start: September 15, 2020
• Primary Completion: June 15, 2021
• Study Completion: August 31, 2021
• Last Updated: September 17, 2021

Record last verified: 2021-09

Locations

CA (1)