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Completed

NCT Number: NCT03135925

Feasibility of Pre Transplant Exercise (Pre-habilitation) for Multiple Myeloma Patients Awaiting Autologous Stem Cell Transplantation

The investigators propose to determine whether it is acceptable to patients with a diagnosis of multiple myeloma (a type of blood cancer that can cause bone weakness, pain and fatigue) to be offered and attend an exercise group before receiving an autologous stem cell transplantation (being given back one's own stem cells, following receipt of intensive chemotherapy, to enable bone marrow to start producing blood cells again). Exercise has been shown to be effective in reducing many of the side effects of myeloma and the treatment patients receive to manage the disease. Prehabilitation i.e. providing an intervention after diagnosis but before treatment begins has been effective in reducing the severity of side effects of treatment in cancer patients receiving surgery. No evidence exists for its use in patients with myeloma. Patients awaiting transplantation will be provided with information regarding the study and invited to join. Patients who agree to take part will attend the hospital for an assessment of their exercise capability and to complete one set of four questionnaires. They will receive an exercise booklet, advice and complete one attempt at their exercise programme under supervision of a physiotherapist. Patients will be requested to attend the gym for a minimum of six further weeks to complete their exercise programme. Patients will complete a repeat set of questionnaires and a repeat walking test six weeks after the first, on admission to hospital for their transplant and on the day they leave hospital. Some patients will be invited to discuss their opinions of the exercise programme and how useful they felt it was to them in preparing for their transplant. If the study shows that the exercise programme is acceptable to patients and we can recruit enough patients to test it in a larger trial, the investigators will apply for further funding.

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Key information

Conditions

Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, South Yorkshire, S10 2JF, United Kingdom

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All patients will have a diagnosis of multiple myeloma and assigned to the autologous transplantation waiting list for either a first or second transplant

Exclusion criteria

  • History of unstable angina or a heart attack in the previous month to allow safe completion of the six minute walk test.
  • Medical stability is a pre-requisite for transplantation so no patients would be excluded on this basis.

Treatment and study plan

Supervised exercise program

Other

Participants will be invited to attend a weekly supervised exercise program over six weeks, in the time before their bone marrow transplantation

Primary outcomes

  1. Number of exercise sessions attended

    Time frame: 12 months

    this is a feasibility study, so monitoring attendance at the study will be the primary outcome measure

Secondary outcomes

  1. Six minute walking distance

    Time frame: At initial assessments and 6th and final exercise session, which will be between 6 and 12 weeks from initial assessment

    Six minute walking distance

  2. Mental well-being

    Time frame: At initial assessments and 6th and final exercise session, which will be between 6 and 12 weeks from initial assessment

    Warwick and Edinburgh Mental Well-being Scale

  3. Physical Activity/fitness 1

    Time frame: At initial assessments and 6th and final exercise session, which will be between 6 and 12 weeks from initial assessment

    Godin Leisure Time

  4. Physical Activity/fitness 2

    Time frame: At initial assessments and 6th and final exercise session, which will be between 6 and 12 weeks from initial assessment

    International Physical Activity Questionnaire

  5. Quality of Life 1

    Time frame: At initial assessments and 6th and final exercise session, which will be between 6 and 12 weeks from initial assessment

    FACT-MM

  6. Quality of Life 2

    Time frame: At initial assessments and 6th and final exercise session, which will be between 6 and 12 weeks from initial assessment

    EORTC QLQ C30 MY20

  7. Self-efficacy with exercise

    Time frame: At initial assessments and 6th and final exercise session, which will be between 6 and 12 weeks from initial assessment

    SCI Self Efficacy for Exercise Scale

Sponsors and collaborators

Lead sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Other

Collaborators

  • National Institute for Health Research, United Kingdom

Registry information

Official study title

Is it Feasible to Conduct a Randomised Controlled Trial of Pre Transplant Exercise (Pre-habilitation) for Multiple Myeloma Patients Awaiting Autologous Stem Cell Transplantation?

Acronym: PREeMPT

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 2, 2017
Registry last updated
Oct 29, 2018

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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