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

Not Applicable
Completed
Conditions
Myeloma
Interventions
Other: Supervised Exercise Program
Registration Number
NCT03135925
Lead Sponsor
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
23
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
InterventionSupervised Exercise ProgramExercise program
Primary Outcome Measures
NameTimeMethod
Number of exercise sessions attended12 months

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

Secondary Outcome Measures
NameTimeMethod
Mental well-beingAt 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

Six minute walking distanceAt initial assessments and 6th and final exercise session, which will be between 6 and 12 weeks from initial assessment

Six minute walking distance

Physical Activity/fitness 1At initial assessments and 6th and final exercise session, which will be between 6 and 12 weeks from initial assessment

Godin Leisure Time

Physical Activity/fitness 2At initial assessments and 6th and final exercise session, which will be between 6 and 12 weeks from initial assessment

International Physical Activity Questionnaire

Quality of Life 1At initial assessments and 6th and final exercise session, which will be between 6 and 12 weeks from initial assessment

FACT-MM

Quality of Life 2At initial assessments and 6th and final exercise session, which will be between 6 and 12 weeks from initial assessment

EORTC QLQ C30 MY20

Self-efficacy with exerciseAt 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

Trial Locations

Locations (1)

Sheffield Teaching Hospitals NHS Foundation Trust

🇬🇧

Sheffield, South Yorkshire, United Kingdom

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