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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03135925
Acronym
PREeMPT
Enrollment
23
Registered
2017-05-02
Start date
2016-09-30
Completion date
2017-09-30
Last updated
2018-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myeloma

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.

Interventions

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

Sponsors

National Institute for Health Research, United Kingdom
CollaboratorOTHER_GOV
Sheffield Teaching Hospitals NHS Foundation Trust
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of exercise sessions attended12 monthsthis is a feasibility study, so monitoring attendance at the study will be the primary outcome measure

Secondary

MeasureTime frameDescription
Mental well-beingAt initial assessments and 6th and final exercise session, which will be between 6 and 12 weeks from initial assessmentWarwick and Edinburgh Mental Well-being Scale
Physical Activity/fitness 1At initial assessments and 6th and final exercise session, which will be between 6 and 12 weeks from initial assessmentGodin Leisure Time
Physical Activity/fitness 2At initial assessments and 6th and final exercise session, which will be between 6 and 12 weeks from initial assessmentInternational Physical Activity Questionnaire
Six minute walking distanceAt initial assessments and 6th and final exercise session, which will be between 6 and 12 weeks from initial assessmentSix minute walking distance
Quality of Life 2At initial assessments and 6th and final exercise session, which will be between 6 and 12 weeks from initial assessmentEORTC 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 assessmentSCI Self Efficacy for Exercise Scale
Quality of Life 1At initial assessments and 6th and final exercise session, which will be between 6 and 12 weeks from initial assessmentFACT-MM

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026