Feasibility of a Community-Based Aquatic Exercise and Peer Support Intervention (Good Boost+) for Adults on Knee Replacement Waiting Lists: A Randomised Hybrid Type 1 Effectiveness-Implementation Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Number (%) of eligible participants recruited to the trial
研究概览
简要总结
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.
详细描述
Knee replacement surgery can greatly reduce pain and improve mobility for people with severe knee arthritis. However, NHS waiting times for surgery are often long, and many people experience worsening pain, reduced ability to work or take part in daily activities, low mood, and increased reliance on strong painkillers while they wait. These challenges can also affect recovery after surgery. Exercise programmes undertaken before surgery, known as 'prehabilitation', may help people feel better during the waiting period and may support better outcomes after surgery. Despite this potential, prehabilitation programmes are not widely available across the UK, and existing provision varies depending on where people live.
There is currently limited evidence about how best to deliver prehabilitation in a way that people waiting for orthopaedic surgery find acceptable, practical, and motivating. It is not yet clear which types of programmes people are most likely to use and stick with while waiting for knee replacement surgery. The Good Boost+ programme offers an approach that combines water-based group exercise in local swimming pools with flexible land-based exercise that can be completed individually or by joining a virtual group. The programme uses digital technology, and pool-based sessions are delivered in community leisure facilities rather than hospital settings. Exercising in water may be more comfortable for people with knee pain, and group sessions supported by refreshments afterwards provide opportunities for social interaction and peer support.
Early pilot work suggests this approach may be promising, but more evidence is needed to understand whether people awaiting knee replacement surgery are willing and able to take part, attend regularly, and complete the programme as intended when delivered alongside usual NHS care. With increasing demand for knee replacement surgery and long waiting times placing strain on patients and the NHS, there is an urgent need to explore new ways of supporting people during the waiting period.
This study is a two arm, parallel group, randomised controlled feasibility trial implementing the Good Boost+ programme for adults awaiting primary total knee replacement. An embedded mixed methods study will explore the acceptability of the intervention and identify determinants influencing the implementation of Good Boost+. The investigators aim to recruit 48 participants from orthopaedic services at NHS Trusts in South London. Participants will be randomly allocated in a 1:1 ratio to receive either usual NHS pre operative care alone or usual NHS pre operative care plus the Good Boost+ programme.
Participants allocated to the intervention group will receive usual NHS care plus the Good Boost+ programme. This includes an initial assessment and goal setting session with an NHS physiotherapist; six weekly group based water exercise sessions delivered in a leisure centre swimming pool using the Good Boost HUB app on a waterproof tablet computer; three home-based land exercise sessions per week using the Good Boost Move Together app on a smartphone or tablet computer; and weekly one to one support sessions with a physiotherapist delivered remotely. Following aquatic sessions, refreshments will be provided to encourage informal peer support. Participants in the control group will continue with usual NHS pre operative care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
The trial statistician will be blinded to arm labels during data analysis. Participants, care providers and investigators will not be masked.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 &
- •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.
排除标准
- •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.
研究组 & 干预措施
Usual NHS Care plus Good Boost+
Participants receive usual NHS pre operative care plus the Good Boost+ programme.
干预措施: Good Boost+ (Behavioral)
Usual NHS Care plus Good Boost+
Participants receive usual NHS pre operative care plus the Good Boost+ programme.
干预措施: Usual NHS Care (Other)
Usual NHS Care
Participants receive usual NHS pre operative care only.
干预措施: Usual NHS Care (Other)
结局指标
主要结局
Number (%) of eligible participants recruited to the trial
时间窗: At the end of the recruitment period (approximately 8 months after recruitment initiation)
Recruitment will be assessed monthly from the start of recruitment until recruitment closes
Retention Rate at 10 weeks post-randomisation
时间窗: Week 10 post-randomisation
The proportion (%) of participants who remain in the study and complete the Week 10 follow-up assessment.
Rate of Adherence to the Good Boost+ Programme
时间窗: Baseline through to 6 weeks after starting the intervention
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.
Proportion of participants with incomplete or missing outcome data.
时间窗: Week 10 post-randomisation
The proportion (%) of participants with incomplete or missing outcome data at week 10 post-randomisation
次要结局
- 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)
- Change in Generic Health Status (EQ 5D 5L Score)(Baseline, Week 6 post-randomisation, Week 10 post-randomisation)
- Healthcare Resource Use(Baseline, Week 10 post-randomisation)
- Change in Mental Well Being (WEMWBS Score)(Baseline, Week 6 post-randomisation, Week 10 post-randomisation)
- Change in Patient Global Assessment (PGA Score)(Baseline, Week 6 post-randomisation, Week 10 post-randomisation)
- Change in Social Support (MOS Social Support Survey Score)(Baseline, Week 6 post-randomisation, Week 10 post-randomisation)
- Change in Pain Intensity (Numerical Pain Rating Scale)(Baseline; Weekly during the 6-week intervention period; Week 10 post-randomisation.)
- Barriers and enablers to implementation(8 weeks post-randomisation onwards (within 1 month of final pool based session))
- Fidelity of intervention delivery (Good Boost+ Water Based Sessions)(Mid-intervention (end of week 3 of the 6-week intervention delivery period); End of intervention (week 6 of the 6-week intervention delivery period))
- Fidelity of Physiotherapist Support Sessions(Weekly during the 6-week intervention period)