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

NCT03135925 | Completed

• 1 other identifier: STH18154
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Myeloma

Outcome Measures

Primary Outcomes (1)

• Number of exercise sessions attended

  this is a feasibility study, so monitoring attendance at the study will be the primary outcome measure

  12 months

Secondary Outcomes (7)

• 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

  At initial assessments and 6th and final exercise session, which will be between 6 and 12 weeks from initial assessment

• Physical Activity/fitness 1

  At initial assessments and 6th and final exercise session, which will be between 6 and 12 weeks from initial assessment

• Physical Activity/fitness 2

  At initial assessments and 6th and final exercise session, which will be between 6 and 12 weeks from initial assessment

• Quality of Life 1

  At initial assessments and 6th and final exercise session, which will be between 6 and 12 weeks from initial assessment

Study Arms (1)

Intervention

OTHER

Exercise program

Other: Supervised Exercise Program

Interventions

Supervised Exercise Program OTHER

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients will have a diagnosis of multiple myeloma and assigned to the autologous transplantation waiting list for either a first or second transplant

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (1)

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, South Yorkshire, S10 2JF, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 29525775 BACKGROUND

• 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.

  PMID: 34563917 DERIVED

MeSH Terms

Conditions

Neoplasms, Plasma Cell

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms

Study Officials

• Susan Mawson

  Sheffield Teaching Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2016
• First Posted: May 2, 2017
• Study Start: September 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: October 29, 2018

Record last verified: 2018-10

Locations

GB (1)