NCT07532785

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
20mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2026

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 16, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

5 months

First QC Date

January 12, 2026

Last Update Submit

April 9, 2026

Conditions

Keywords

Total Knee ReplacementPrehabilitationFeasibilityRandomised controlled trialImplementation

Outcome Measures

Primary Outcomes (4)

  • Number (%) of eligible participants recruited to the trial

    Recruitment will be assessed monthly from the start of recruitment until recruitment closes

    At the end of the recruitment period (approximately 8 months after recruitment initiation)

  • Retention Rate at 10 weeks post-randomisation

    The proportion (%) of participants who remain in the study and complete the Week 10 follow-up assessment.

    Week 10 post-randomisation

  • 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.

    Baseline through to 6 weeks after starting the intervention

  • Proportion of participants with incomplete or missing outcome data.

    The proportion (%) of participants with incomplete or missing outcome data at week 10 post-randomisation

    Week 10 post-randomisation

Secondary Outcomes (14)

  • Acceptability of Good Boost+ / Usual NHS care to patients using Theoretical Framework of Acceptability (TFA) questionnaire scores

    Baseline, Week 6 post-randomisation, Week 10 post-randomisation

  • Acceptability of Good Boost+ to NHS staff and leisure centre staff.

    Baseline (at the start of intervention delivery at the relevant site); Mid-intervention (during month 4 of the 8-month intervention delivery period)

  • Acceptability of Good Boost+ to patients wait listed for knee replacement, NHS staff and leisure centre staff using qualitative interviews

    8 weeks post-randomisation onwards (within 1 month of final pool based session)

  • Change in pain, function and stiffness (WOMAC score)

    Baseline, Week 6 post-randomisation, Week 10 post-randomisation

  • Change in Musculoskeletal Health (MSK HQ Score)

    Baseline, Week 6 post-randomisation, Week 10 post-randomisation

  • +9 more secondary outcomes

Study Arms (2)

Usual NHS Care plus Good Boost+

EXPERIMENTAL

Participants receive usual NHS pre operative care plus the Good Boost+ programme.

Behavioral: Good Boost+Other: Usual NHS Care

Usual NHS Care

OTHER

Participants receive usual NHS pre operative care only.

Other: Usual NHS Care

Interventions

Good Boost+BEHAVIORAL

Good 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 plus Good Boost+

Standard 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

Usual NHS CareUsual NHS Care plus Good Boost+

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18 years or over. Registered on a wait list for primary total knee replacement with sufficient time to complete the 6 week intervention and follow up assessments prior to surgery.
  • Moderate self reported intensity knee joint pain within the previous month, defined as ≥4 but \<10 on the 11 point Numeric Pain Rating Scale (NPRS: 0 = no pain, 10 = worst pain imaginable).
  • Willing and able to participate in a six week programme of weekly group water-based exercise at specified leisure centre swimming pools in Southwark and three times weekly land-based exercise training in a private setting.
  • Willing to pay £4.30 for water-based exercise sessions 5 \& 6. This fee is in line with the usual cost of over 60s group exercise classes at local leisure centres.
  • Access to a smart phone or tablet computer with internet access. Willing and able to accept either trial arm allocation. Willing and able to give informed consent.

You may not qualify if:

  • Individuals scheduled to have another major joint replacement (e.g. contralateral knee, hip or shoulder) within the study period.
  • Individuals on the waiting list for revision surgery of a previous knee replacement.
  • Individuals with active inflammatory arthritis (e.g., RA, PsA, lupus, axial SpA) that is clinically symptomatic or requires ongoing immunosuppressive therapy to control disease activity.
  • Individuals who self-report being advised by a healthcare professional not to exercise.
  • Individuals who have previously participated in water-based exercise sessions delivered via the Good Boost HUB application.
  • Participating or planning to participate in another interventional clinical study/trial during the study period that in the opinion of the investigator could affect the outcomes of this study.
  • Individuals unable to understand written or spoken English or communicate sufficiently well in English to participate despite assistance from a family member or friend.
  • Individuals unable to comply with the protocol / requirements of study participation.
  • Individuals with any other severe concomitant disease that, in the opinion of the investigator might interfere with trial procedures and/or assessments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King's College Hospital NHS Foundation Trust

London, England, SE5 9RS, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The trial statistician will be blinded to arm labels during data analysis. Participants, care providers and investigators will not be masked.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Intervention arm: Good Boost+: a physiotherapist led six week personalised exercise and peer support community based prehabilitation intervention Control arm: Usual pre operative NHS care
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2026

First Posted

April 16, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

February 1, 2028

Last Updated

April 16, 2026

Record last verified: 2026-04

Locations