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

Primary Purpose

Myeloma

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Supervised Exercise Program
Sponsored by
Sheffield Teaching Hospitals NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sheffield Teaching Hospitals NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Intervention

Arm Description

Exercise program

Outcomes

Primary Outcome Measures

Number of exercise sessions attended
this is a feasibility study, so monitoring attendance at the study will be the primary outcome measure

Secondary Outcome Measures

Six minute walking distance
Six minute walking distance
Mental well-being
Warwick and Edinburgh Mental Well-being Scale
Physical Activity/fitness 1
Godin Leisure Time
Physical Activity/fitness 2
International Physical Activity Questionnaire
Quality of Life 1
FACT-MM
Quality of Life 2
EORTC QLQ C30 MY20
Self-efficacy with exercise
SCI Self Efficacy for Exercise Scale

Full Information

First Posted
September 27, 2016
Last Updated
October 25, 2018
Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
Collaborators
National Institute for Health Research, United Kingdom
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1. Study Identification

Unique Protocol Identification Number
NCT03135925
Brief Title
Feasibility of Pre Transplant Exercise (Pre-habilitation) for Multiple Myeloma Patients Awaiting Autologous Stem Cell Transplantation
Acronym
PREeMPT
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 Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
Collaborators
National Institute for Health Research, United Kingdom

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Other
Arm Description
Exercise program
Intervention Type
Other
Intervention Name(s)
Supervised Exercise Program
Intervention Description
Participants will be invited to attend a weekly supervised exercise program over six weeks, in the time before their bone marrow transplantation
Primary Outcome Measure Information:
Title
Number of exercise sessions attended
Description
this is a feasibility study, so monitoring attendance at the study will be the primary outcome measure
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Six minute walking distance
Description
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
Title
Mental well-being
Description
Warwick and Edinburgh Mental Well-being Scale
Time Frame
At initial assessments and 6th and final exercise session, which will be between 6 and 12 weeks from initial assessment
Title
Physical Activity/fitness 1
Description
Godin Leisure Time
Time Frame
At initial assessments and 6th and final exercise session, which will be between 6 and 12 weeks from initial assessment
Title
Physical Activity/fitness 2
Description
International Physical Activity Questionnaire
Time Frame
At initial assessments and 6th and final exercise session, which will be between 6 and 12 weeks from initial assessment
Title
Quality of Life 1
Description
FACT-MM
Time Frame
At initial assessments and 6th and final exercise session, which will be between 6 and 12 weeks from initial assessment
Title
Quality of Life 2
Description
EORTC QLQ C30 MY20
Time Frame
At initial assessments and 6th and final exercise session, which will be between 6 and 12 weeks from initial assessment
Title
Self-efficacy with exercise
Description
SCI Self Efficacy for Exercise Scale
Time Frame
At initial assessments and 6th and final exercise session, which will be between 6 and 12 weeks from initial assessment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Mawson
Organizational Affiliation
Sheffield Teaching Hospitals NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheffield Teaching Hospitals NHS Foundation Trust
City
Sheffield
State/Province
South Yorkshire
ZIP/Postal Code
S10 2JF
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29525775
Citation
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.
Results Reference
background
PubMed Identifier
34563917
Citation
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.
Results Reference
derived

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

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