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NCT Number: NCT06280924

Prehab Prior to Stem Cell Transplantation in Multiple Myeloma

The primary purpose of this study is to see if individuals with Multiple Myeloma are able and interested in taking part in a tailored exercise program while undergoing their chemotherapy prior to a stem cell transplant. We also hope to learn if this type of program, along with a flexible delivery format (in-person and virtual), helps in maintaining or improving physical fitness, muscle mass and strength, and quality of life during chemotherapy.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alberta/ Cross Cancer Institute

Edmonton, Alberta, T6G 2G4, Canada

Location status: Recruiting

Location contact

Margaret L. McNeely, PhD

PRINCIPAL_INVESTIGATOR

Margaret McNeely, PhD

CONTACT

[email protected]

780-248-1531

About this study

MOTIVATE is a multi-methods feasibility randomized trial. We will recruit a minimum of 30 individuals with multiple myeloma who are undergoing chemotherapy prior to a Stem Cell Transplant. The study will be conducted in two phases:

Phase I: Feasibility Study The aim of this phase is to determine the feasibility and preliminary effectiveness of a 10-week exercise intervention compared to physical activity counseling alone.

Phase II: Qualitative Study The aim of this phase is to evaluate the acceptability of the Healthy Eating Active Living (HEAL-ME) app design, program delivery/design, and perceived effectiveness of the intervention at the level of the participant.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Have a diagnosis of Multiple Myeloma
  • Be transplant eligible
  • Be undergoing chemotherapy prior to, or following an autologous stem cell transplant as part of their cancer treatment; or transplant ineligible.
  • Be an Alberta resident
  • Be ≥18 years of age
  • Be able to read and understand English.

Exclusion criteria

  • Their disease status/comorbidities preclude exercise testing or participation
  • They are unable to commit to the 10-week exercise program and/or testing sessions at the Cancer Rehabilitation Clinic at the University of Alberta
  • They do not have regular access to the internet and/or an electronic device in the home.

Treatment and study plan

Supported Exercise

Behavioral

Participants will take part in a prehabilitation exercise program prior to undergoing a stem cell transplant.

Standard Care

Behavioral

Participants will receive standard care

Primary outcomes

  1. Study completion rate

    Time frame: 10-weeks

    The percentage of participants who complete the study, including the intervention and follow-up assessment

Secondary outcomes

  1. Recruitment rate

    Time frame: 18 months

    The percentage of participants who are eligible and consent to participate in the study.

  2. Attendance rate

    Time frame: 18 months

    The percentage of group and individual exercise sessions completed over the 10 weeks.

  3. Edmonton Symptom Assessment System

    Time frame: 10 weeks

    Tool to assess 11 symptoms related to cancer: higher scores reflect worse symptom burden

  4. Functional Assessment of Cancer Therapy Multiple Myeloma

    Time frame: 10 weeks

    Health-related quality of life questionnaire: higher scores reflect better quality of life

  5. Functional Assessment of Cancer Therapy: Fatigue Subscale (13-item)

    Time frame: 10 weeks

    Fatigue questionnaire: higher scores reflect less fatigue

  6. Body weight

    Time frame: 10 weeks

    Weight measured in kilograms

  7. Body height

    Time frame: 10 weeks

    Weight measured in centimetres (to nearest 0.5 cm)

  8. Grip Strength

    Time frame: 10 weeks

    Hand grip measured in kilograms using a dynamometer

  9. Calf muscle size

    Time frame: 10 weeks

    Calf circumference measured in centimetres to the nearest 0.1 cm

  10. Thigh muscle thickness

    Time frame: 10 weeks

    Ultrasound measurement of rectus femoris muscle cross-sectional area

  11. Short Physical Performance Battery

    Time frame: 10 weeks

    Test includes 4-meter timed walk, balance and 5-repetition sit-to-stand

  12. Six-minute walk test

    Time frame: 10 weeks

    Distance covered in metres (to nearest cm) in 6 minutes (hallway)

  13. One leg stance balance

    Time frame: 10 weeks

    Time standing on one foot (to a maximum of 45 seconds)

  14. Shoulder flexion range of motion

    Time frame: 10 weeks

    Upper limb flexibility measured in degrees

  15. Sit and reach test

    Time frame: 10 weeks

    Lower limb flexibility measured in cms (to nearest 0.5 cm)

Study contacts

Contact information is provided by the study sponsor or research team.

Margaret L McNeely, PhD

CONTACT

[email protected]

7802890972

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study title

Multiple Myeloma Exercise Prehabilitation for Individuals Awaiting a Stem Cell Transplantation (MOTIVATE): A Randomized Controlled Feasibility Trial

Acronym: MOTIVATE

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 28, 2024
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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