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

October 25, 2018 updated by: Sheffield Teaching Hospitals NHS Foundation Trust

Is it Feasible to Conduct a Randomised Controlled Trial 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • South Yorkshire
      • Sheffield, South Yorkshire, United Kingdom, S10 2JF
        • Sheffield Teaching Hospitals NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At initial assessments and 6th and final exercise session, which will be between 6 and 12 weeks from initial assessment
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
At initial assessments and 6th and final exercise session, which will be between 6 and 12 weeks from initial assessment
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
At initial assessments and 6th and final exercise session, which will be between 6 and 12 weeks from initial assessment
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
At initial assessments and 6th and final exercise session, which will be between 6 and 12 weeks from initial assessment
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
At initial assessments and 6th and final exercise session, which will be between 6 and 12 weeks from initial assessment
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
At initial assessments and 6th and final exercise session, which will be between 6 and 12 weeks from initial assessment
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
At initial assessments and 6th and final exercise session, which will be between 6 and 12 weeks from initial assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Collaborators

National Institute for Health Research, United Kingdom

Investigators

  • Principal Investigator: Susan Mawson, Sheffield Teaching Hospitals NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

September 27, 2016

First Submitted That Met QC Criteria

April 26, 2017

First Posted (Actual)

May 2, 2017

Study Record Updates

Last Update Posted (Actual)

October 29, 2018

Last Update Submitted That Met QC Criteria

October 25, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STH18154

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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