MyelomaPREeMPTNCT03135925
Feasibility of Pre Transplant Exercise (Pre-habilitation) for Multiple Myeloma Patients Awaiting Autologous Stem Cell Transplantation
A study testing Supervised Exercise Program in people with Myeloma, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloma
- What is being tested?
- Supervised Exercise Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2016to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients will have a diagnosis of multiple myeloma and assigned to the autologous transplantation waiting list for either a first or second transplant
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, South Yorkshire, S10 2JF
About this study
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?
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.
- Conditions
- Myeloma
- Being tested
- Supervised Exercise Program
- Medical subject headings
- Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised Exercise ProgramOther
Participants will be invited to attend a weekly supervised exercise program over six weeks, in the time before their bone marrow transplantation
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | Exercise program Receives: Other: Supervised Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of exercise sessions attended
this is a feasibility study, so monitoring attendance at the study will be the primary outcome measure
Measured: 12 months
Secondary outcomes (7)
Six minute walking distance
Six minute walking distance
Measured: At initial assessments and 6th and final exercise session, which will be between 6 and 12 weeks from initial assessment
Mental well-being
Warwick and Edinburgh Mental Well-being Scale
Measured: At initial assessments and 6th and final exercise session, which will be between 6 and 12 weeks from initial assessment
Physical Activity/fitness 1
Godin Leisure Time
Measured: At initial assessments and 6th and final exercise session, which will be between 6 and 12 weeks from initial assessment
Physical Activity/fitness 2
International Physical Activity Questionnaire
Measured: At initial assessments and 6th and final exercise session, which will be between 6 and 12 weeks from initial assessment
Quality of Life 1
FACT-MM
Measured: At initial assessments and 6th and final exercise session, which will be between 6 and 12 weeks from initial assessment
Quality of Life 2
EORTC QLQ C30 MY20
Measured: At initial assessments and 6th and final exercise session, which will be between 6 and 12 weeks from initial assessment
Self-efficacy with exercise
SCI Self Efficacy for Exercise Scale
Measured: At initial assessments and 6th and final exercise session, which will be between 6 and 12 weeks from initial assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study startSep 2016
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Susan Mawson, Principal investigator, Sheffield Teaching Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03135925
- Sponsor's protocol ID
- STH18154
- Acronym
- PREeMPT
- Status last verified
- Oct 2018
- First submitted
- 27 Sep 2016
- Last updated
- 29 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 29525775Mawson 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.
PubMed 34563917
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?
- ClinicalTrials.gov ID
- NCT03135925
- Acronym / sponsor ID
- PREeMPT / STH18154
- Conditions
- Myeloma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- Sep 2016 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 2 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Other: Supervised Exercise ProgramExercise program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients will have a diagnosis of multiple myeloma and assigned to the autologous transplantation waiting list for either a first or second transplant
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supervised Exercise ProgramParticipants will be invited to attend a weekly supervised exercise program over six weeks, in the time before their bone marrow transplantation | Other | Intervention |
Primary outcome
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
7 secondary outcomes
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2018.
- Background: PubMed 29525775Keen 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.
- Derived from this study: PubMed 34563917Mawson 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Mawson principal investigator
Sheffield Teaching Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised Exercise Program in people with Myeloma, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of exercise sessions attended (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03135925, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2018.