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

Myeloma Clinical Trial

— 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?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03135925
• Other study ID #: STH18154
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: September 2017

Study information

• Verified date: October 2018
• Source: Sheffield Teaching Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Myeloma
• Neoplasms, Plasma Cell

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Sheffield Teaching Hospitals NHS Foundation Trust	Sheffield	South Yorkshire

Sponsors (2)

Lead Sponsor	Collaborator
Sheffield Teaching Hospitals NHS Foundation Trust	National Institute for Health Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Six minute walking distance	Six minute walking distance	At initial assessments and 6th and final exercise session, which will be between 6 and 12 weeks from initial assessment
Secondary	Mental well-being	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
Secondary	Physical Activity/fitness 1	Godin Leisure Time	At initial assessments and 6th and final exercise session, which will be between 6 and 12 weeks from initial assessment
Secondary	Physical Activity/fitness 2	International Physical Activity Questionnaire	At initial assessments and 6th and final exercise session, which will be between 6 and 12 weeks from initial assessment
Secondary	Quality of Life 1	FACT-MM	At initial assessments and 6th and final exercise session, which will be between 6 and 12 weeks from initial assessment
Secondary	Quality of Life 2	EORTC QLQ C30 MY20	At initial assessments and 6th and final exercise session, which will be between 6 and 12 weeks from initial assessment
Secondary	Self-efficacy with exercise	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