Clinical trial NCT03135925: Feasibility of Pre Transplant Exercise (Pre-habilitation) for Multiple Myeloma Patients Awaiting Autologous Stem Cell Transplantation
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
Overall status: COMPLETED
Phase: NA
Conditions: Myeloma
Lead sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
First posted: 2017-05-02
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of exercise sessions attended
timeFrame: 12 months
Secondary outcomes:
measure: Six minute walking distance
timeFrame: At initial assessments and 6th and final exercise session, which will be between 6 and 12 weeks from initial assessment
measure: Mental well-being
timeFrame: At initial assessments and 6th and final exercise session, which will be between 6 and 12 weeks from initial assessment
measure: Physical Activity/fitness 1
timeFrame: At initial assessments and 6th and final exercise session, which will be between 6 and 12 weeks from initial assessment
measure: Physical Activity/fitness 2
timeFrame: At initial assessments and 6th and final exercise session, which will be between 6 and 12 weeks from initial assessment
measure: Quality of Life 1
timeFrame: At initial assessments and 6th and final exercise session, which will be between 6 and 12 weeks from initial assessment
measure: Quality of Life 2
timeFrame: At initial assessments and 6th and final exercise session, which will be between 6 and 12 weeks from initial assessment
measure: Self-efficacy with exercise
timeFrame: At initial assessments and 6th and final exercise session, which will be between 6 and 12 weeks from initial assessment
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS Foundation Trust
state: South Yorkshire
Study officials:
affiliation: Sheffield Teaching Hospitals NHS Foundation Trust
name: Susan Mawson
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.