PERCEPT - myeloma transplant prehab study
Research type
Research Study
Full title
Pilot randomised controlled trial of a physiotherapist-led exercise intervention delivered prior to and during stem cell transplant in patients with myeloma
IRAS ID
254814
Contact name
Orla McCourt
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
Z6364106/2018/11/76, UCL Data Protection Registration Number
Duration of Study in the UK
1 years, 8 months, 30 days
Research summary
The primary objective of this study is to evaluate the feasibility of delivering an exercise and behaviour change intervention prior to and during the usual autologous stem cell transplant treatment pathway in people with myeloma. Secondary objectives are to investigation of the possible effect of the intervention on a range of measures including fatigue, quality of life, physical activity and functional capacity.
This pilot randomised, single site trial will involve participants with myeloma undergoing autologous stem cell transplantation (ASCT). This trial has two arms; an exercise intervention arm and a usual care control arm. Eligible participants will be randomised to an exercise intervention group or usual care control group. Assessments will be conducted at four timepoints; baseline assessment 4-6 weeks prior to ASCT, and follow up assessments on day before or day of transplantation, on discharge from hospital and three months’ post ASCT. Assessments will involve questionnaires regarding fatigue, quality of life (QOL), exercise self-efficacy, physical activity, accelerometery and physical assessments including a walk test, sit to stand test and handheld dynamometry. In the final follow up participants will also complete a questionnaire on health and social care usage and approximately 20 participants will participant in qualitative interviews.
Participants randomised to the exercise intervention arm will be asked to undertake a partly supervised, physiotherapist led, individually tailored exercise programme for up to 8 weeks prior to their transplant as an outpatient, which will be continued during hospitalisation for transplant treatment. The exercise programme will be carried out three time per week. Following discharge from hospital, the participants in the exercise intervention arm will be offered weekly telephone support from a physiotherapist to promote and support continuation or return to independent exercise in the post transplant period (for up to 3 months).
REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
19/LO/0204
Date of REC Opinion
11 Mar 2019
REC opinion
Favourable Opinion