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

NCT ID: NCT03135925

Last Updated: 2018-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-09-30

Brief Summary

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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

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Conditions

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Myeloma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

Exercise program

Group Type OTHER

Supervised Exercise Program

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute for Health Research, United Kingdom

OTHER_GOV

Sponsor Role collaborator

Sheffield Teaching Hospitals NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Susan Mawson

Role: PRINCIPAL_INVESTIGATOR

Sheffield Teaching Hospitals NHS Foundation Trust

Locations

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Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, South Yorkshire, United Kingdom

Site Status

Countries

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United Kingdom

References

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Keen C, Skilbeck J, Ross H, Smith L, Collins K, Dixey J, Walters S, Greenfield DM, Snowden JA, Mawson S. Is it feasible to conduct a randomised controlled trial of pretransplant exercise (prehabilitation) for patients with multiple myeloma awaiting autologous haematopoietic stem cell transplantation? Protocol for the PREeMPT study. BMJ Open. 2018 Mar 9;8(3):e021333. doi: 10.1136/bmjopen-2017-021333.

Reference Type BACKGROUND
PMID: 29525775 (View on PubMed)

Mawson S, Keen C, Skilbeck J, Ross H, Smith L, Dixey J, Walters SJ, Simpson R, Greenfield DM, Snowden JA. Feasibility and benefits of a structured prehabilitation programme prior to autologous stem cell transplantation (ASCT) in patients with myeloma; a prospective feasibility study. Physiotherapy. 2021 Dec;113:88-99. doi: 10.1016/j.physio.2021.08.001. Epub 2021 Aug 5.

Reference Type DERIVED
PMID: 34563917 (View on PubMed)

Other Identifiers

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STH18154

Identifier Type: -

Identifier Source: org_study_id

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