Feasibility of Good Boost+ for Adults Awaiting Total Knee Replacement
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKing's College Hospital NHS Trust
About this trial
The goal of this randomised controlled feasibility trial is to find out whether it is possible to run a larger study of the Good Boost+ community based rehabilitation programme for people waiting for a primary total knee replacement.
The study will look at how many people are willing to take part, whether they stay in the study, and whether they can follow the Good Boost+ programme as planned. It will also explore how acceptable the programme is to patients, NHS staff and leisure centre staff, and which outcome measures are most useful for a future full scale trial. The study will also look at what helps or hinders delivery of the programme in real world NHS and community settings.
The main questions it aims to answer are:
* How many people waiting for knee replacement surgery are willing to take part in the study * Whether participants can continue with the Good Boost+ programme as planned over the study period * Which outcome measures best capture any potential benefits of the programme * How acceptable the programme is to patients, NHS and leisure centre staff * What helps or makes it difficult to deliver the programme in practice.
Participants will be randomly assigned to one of two groups.
* Usual NHS care or * Usual NHS care plus the Good Boost+ programme
Participants in the Good Boost+ programme will take part in six weekly group water based exercise sessions held in local swimming pools, as well as land based exercise sessions that can be done individually or by joining a virtual group. The exercise sessions are delivered through Good Boost's digital technology, using small waterproof tablet computers at swimming pools, and smartphones or computers for land-based sessions. Physiotherapy staff will provide guidance throughout, and volunteers will offer refreshments after pool sessions to support social connection.
All participants, including those receiving usual NHS care only, will be asked to complete an exercise diary, rate their knee pain each week, and complete short questionnaires at 6 and 10 weeks after joining the study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Good Boost+
BehavioralGood Boost+ is a six week personalised exercise and peer support community based rehabilitation programme, combining water based group exercise and land based home exercise. Participants attend one group aquatic exercise session per week at a local leisure centre, delivered using the Good Boost digital application on a waterproof tablet computer. Participants also complete three land based exercise sessions per week at home or in another suitable space, accessed via the Good Boost Move Together app on a smartphone or tablet computer. An initial assessment and goal setting session is completed with an NHS physiotherapist. Participants receive weekly one to one remote support from a physiotherapist throughout the programme. Informal peer support is encouraged through refreshments provided after pool based sessions.
Usual NHS Care
Other interventionStandard NHS pre operative care for individuals awaiting primary total knee replacement, delivered according to local NHS practice. No additional structured exercise or prehabilitation components are provided
Treatment groups
48 Participants
are divided into 2 treatment groupsGroup A: Usual NHS Care plus Good Boost+Experimental treatment 2 interventions
Group B: Usual NHS CareOther 1 intervention
Trial outcomes
Primary outcomes
1
Number (%) of eligible participants recruited to the trial
Recruitment will be assessed monthly from the start of recruitment until recruitment closes
Time frame
At the end of the recruitment period (approximately 8 months after recruitment initiation)2
Retention Rate at 10 weeks post-randomisation
The proportion (%) of participants who remain in the study and complete the Week 10 follow-up assessment.
Time frame
Week 10 post-randomisation3
Rate of Adherence to the Good Boost+ Programme
Adherence to the Good Boost+ programme will be measured weekly as the percentage of prescribed sessions completed by each participant over the 6-week programme. Adherence will be defined as engagement with ≥3 pool-based sessions, ≥9 land-based exercise sessions (self-reported), and at least one remote support session (telephone or video call) with the physiotherapist.
Time frame
Baseline through to 6 weeks after starting the intervention4
Proportion of participants with incomplete or missing outcome data.
The proportion (%) of participants with incomplete or missing outcome data at week 10 post-randomisation
Time frame
Week 10 post-randomisationSecondary outcomes
1
Acceptability of Good Boost+ / Usual NHS care to patients using Theoretical Framework of Acceptability (TFA) questionnaire scores
Scores on the adapted Theoretical Framework of Acceptability (TFA) questionnaire completed by patients waitlisted for knee replacement. This adapted TFA questionnaire has 7 items, each with a minimum score of 1 and maximum of 5 (with higher scores reflecting greater acceptability).
Time frame
Baseline, Week 6 post-randomisation, Week 10 post-randomisation2
Acceptability of Good Boost+ to NHS staff and leisure centre staff.
Scores on the adapted TFA questionnaire completed by NHS staff and leisure centre staff involved in delivering or supporting Good Boost+. This adapted TFA questionnaire has 7 items, each with a minimum score of 1 and maximum of 5 (with higher scores reflecting greater acceptability).
Time frame
Baseline (at the start of intervention delivery at the relevant site); Mid-intervention (during month 4 of the 8-month intervention delivery period)3
Acceptability of Good Boost+ to patients wait listed for knee replacement, NHS staff and leisure centre staff using qualitative interviews
Qualitative assessment of acceptability based on semi structured interviews with patients, NHS staff and leisure centre staff
Time frame
8 weeks post-randomisation onwards (within 1 month of final pool based session)4
Change in pain, function and stiffness (WOMAC score)
A 24-item disease specific measurement tool commonly used in hip and knee osteoarthritis. WOMAC enables an assessment of pain (5 items), stiffness (2 items) and physical functioning (17 items). The scores range between 0-20 for pain; 0-8 for stiffness; and 0-68 for physical function, with higher scores indicative of worse pain, stiffness and functioning.
Time frame
Baseline, Week 6 post-randomisation, Week 10 post-randomisationSponsors and contacts
Click on the lead sponsor to view all of their trials.
King's College Hospital NHS Trust
Lead sponsor
King's College London
Collaborator
University of Leicester
Collaborator
University of Leeds
Collaborator
National Institute of Health and Care Research, United Kingdom
Collaborator
Imperial College London
Collaborator
Source ClinicalTrials.gov