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

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ClinicalTrials.gov Identifier: NCT03135925
Recruitment Status : Recruiting
First Posted : May 2, 2017
Last Update Posted : September 5, 2018
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
Sheffield Teaching Hospitals NHS Foundation Trust

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Myeloma Other: Supervised Exercise Program Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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?
Study Start Date : September 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018


Arm Intervention/treatment
Intervention
Exercise program
Other: Supervised Exercise Program
Participants will be invited to attend a weekly supervised exercise program over six weeks, in the time before their bone marrow transplantation




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03135925


Contacts
Contact: Susan Mawson susan.mawson@sth.nhs.uk
Contact: Carol Keen 0114 271 2054 carol.keen@sth.nhs.uk

Locations
United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust Recruiting
Sheffield, South Yorkshire, United Kingdom, S10 2JF
Contact: Susan Mawson       susan.mawson@sth.nhs.uk   
Contact: Carol Keen    0114 271 2054    carol.keen@sth.nhs.uk   
Sponsors and Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust
National Institute for Health Research, United Kingdom
Investigators
Principal Investigator: Susan Mawson Sheffield Teaching Hospitals NHS Foundation Trust

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03135925     History of Changes
Other Study ID Numbers: STH18154
First Posted: May 2, 2017    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases