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Pilot trial of inter-disciplinary PREHABilitation after colonoscopy

Pilot trial of an inter-disciplinary prehabilitation programme for adults referred to surgical services after colonoscopy at Auckland District Health Board

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619001667101
Acronym
PREHAB
Enrollment
20
Registered
2019-11-28
Start date
2020-07-13
Completion date
2021-03-02
Last updated
2021-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study seeks to collect pilot and feasibility data that will inform the design of future trials of prehabilitation for bowel cancer patients at Auckland District Health Board. People who have had a colonoscopy and have been referred to surgical services will be eligible to take part. Those who decide to participate will be interviewed by a prehabilitation programme coordinator to understand their needs and preferences. They will then be referred for exercise testing and training and physiotherapy, occupational therapy, dietary advice, and health psychology, as needed. The exercise sessions are intense but brief, and are supervised by an exercise physiologist. The prehabilitation programme is focused on high intensity interval training with pre- and post-training assessment of cardiorespiratory fitness. Additional measures of post-surgical outcomes and feasibility data will be collected. This information will help to estimate effect size, and allow accurate calculation of sample size for future trials. Participants will also be interviewed to understand their experience of prehabilitation, and identify the barriers and facilitators to them taking part. The new information gained will be shared with participants, families, and the clinical teams, for sense-checking prior to interpretation and reporting.

Interventions

Participants will be enrolled in a flexible inter-disciplinary prehabilitation programme if they are referred to surgical services after colonoscopy. The aim of this programme is to prepare participants physically, mentally, and emotionally for possible bowel surgery. The programme includes physical activity, physiotherapy, occupational therapy, dietetics, and health psychology. Each of these services will be made available to participants by experienced registered clinicians working in an inter

Participants will be enrolled in a flexible inter-disciplinary prehabilitation programme if they are referred to surgical services after colonoscopy. The aim of this programme is to prepare participants physically, mentally, and emotionally for possible bowel surgery. The programme includes physical activity, physiotherapy, occupational therapy, dietetics, and health psychology. Each of these services will be made available to participants by experienced registered clinicians working in an inter-disciplinary team at the Auckland District Health Board (ADHB). Each of these services are described below. The prehabilitation programme coordinator will first meet with each potential participant to discuss the study, obtain their written informed consent, and assess their needs and preferences for the components of the prehabilitation programme. This is expected to take approximately one hour. The coordinator will then refer participants to services as indicated. Physical activity: Participants will be invited to complete an exercise test with an ADHB clinical exercise physiologist, to evaluate their current level of cardiovascular fitness and prescribe a programme of supervised high-intensity interval training (HIIT). The programme involves exercising on a treadmill or stationery bike, depending on participant preference and clinician judgement. This programme is designed to efficiently increase cardiovascular fitness in 3 sessions per week for up to 4 weeks, while participants await their surgical treatment. HIIT will begin as soon as possible after participants join the prehabilitation programme, and will stop at least 72 hours prior to scheduled surgery. The duration of the programme is therefore flexible, depending on the amount of time available prior to scheduled surgery. If the 4 week programme is completed prior to surgical treatment, participants will be asked to complete a final CPET and may continue with a maintenance programme that involves 3 sessions per week. The level of intensity of physical activity is monitored in each session by continuous monitoring of participants' heart rate by trained clinicians, who supervise every session. The potential risks and benefits of exercise testing and high intensity interval training are clearly described for participants, and they can choose to opt out of this component of the prehabilitation programme while continuing with the rest of the programme. The clinical exercise physiologist responsible for the initial exercise test will evaluate each participant for contraindications to exercise testing and high intensity interval training. Sessions will be scheduled at participants' convenience whenever possible. Both exercise tests will take place at the Greenlane Clinical Centre. Subsequent training sessions will take place at the Greenlane Clinical Centre or community facilities, such as YMCA gyms, depending upon participant preference and clinician availability. Participants who are contraindicated or who choose not to engage with exercise testing and/or high intensity interval training will be offered education and support to engage in daily moderate physical activity (at least 30 minutes of walking per day), with encouragement from a physiotherapist in the form of weekly telephone calls. This moderate intensity, self-directed activity option will be offered by the prehabilitation programme coordinator, provided there are no contraindications detected using the Physical Activity Readiness Questionnaire (PAR-Q). If contraindications are detected with the PAR-Q, participants will be asked to consult their GP regarding their readiness to undertake a moderate intensity exercise programme, and to follow their GP's advice. Physiotherapy: Participants with limitations in strength and mobility will be referred to ADHB physiotherapy services for treatment. Therapy will be individualised, and designed to improve the strength and condition of each participant using standard physiotherapy techniques. The physiotherapist will also provide education and support for participants who engage in moderate intensity self-directed physical activity, as described above. Physiotherapy sessions will take place in person at Auckland City Hospital, community centres such as the YMCA, or in the participant's home, depending on participant preferences and physiotherapist availability. Therapy sessions are expected to last no more than an hour, and their frequency will be based on the physiotherapist's clinical judgement and patient preferences. Education and support for moderate intensity self-directed physical activity will take place via telephone or Zoom videoconference, depending on participant preference. Note that Zoom is approved for clinical use by the ADHB. Occupational therapy: Participants experiencing limitations due to fatigue or with equipment needs at home will be referred to ADHB occupational therapy services as indicated. The prehabilitation coordinator will use the Brief Fatigue Inventory to screen for fatigue and will make a referral to occupational therapy if the score is 6 or more in any of the nine assessment domains. Therapy will be individualised and designed to improve fatigue management and maximise independence in the home environment, using standard occupational therapy approaches. One-on-one sessions will take place at Auckland City Hospital or in the participant’s home, and the location and frequency will depend on participant preferences and therapist availability. All participants will also be invited to attend a fatigue management education session as part of their prehabilitation. The purpose of this session is to provide advice and an opportunity to address any queries or concerns that participants may have. It will last for approximately 30 minutes, and will take place either at Greenlane Clinical Centre, or at a local community facility such as the YMCA, as described above. Dietetics: Participants will be screened for nutrition needs using the Malnutrition Universal Screening Tool (MUST), and referred to an ADHB dietitian as indicated (score of 2 or more). The dietitian will provide individualised advice and support to improve the nutritional status of referred participants, using standard approaches One-on-one sessions will take place at Auckland City Hospital, in the participant’s home, or via Zoom teleconference, and the location and frequency will depend on participant preferences and therapist availability. All participants will also be invited to attend a nutrition education session as part of their pre-habilitation. The purpose of this session is to provide dietary advice for people preparing for bowel surgery, and an opportunity to address any queries or concerns that participants may have. It will last for approximately 30 minutes, and take place either at Greenlane Clinical Centre, or at a local community facility such as the YMCA, as described above. Health Psychology: Participants will be screened by the prehabilitation coordinator with the Psychology and Wellbeing Screen (National Comprehensive Cancer Network Distress Thermometer) and referred to ADHB health psychology services as indicated (score of 4 or more). The health psychologist will provide individualised advice, counselling and support to assist referred participants, using standard approaches. One-on-one sessions will take place at Auckland City Hospital, in the participant’s home, or via Zoom teleconference, and the location and frequency will depend on participant preferences and therapist availability. All participants will also be invited to attend an education session to provide general psychological advice for people preparing for bowel surgery, and an opportunity to address any queries or concerns that participants may have. It will last for approximately 30 minutes, and take place either at Greenlane Clinical Centre, or at a local community facility such as the YMCA, as described above. The effect size of HIIT training will be estimated by calculating the percentage change in VO2max in L/min between the initial and final CPET assessments. The effects of prehabilitation will be measured by: length of hospital stay for participants, compared to a similar cohort of ADHB patients; the Surgical Recovery Scale; and the Post-operative Morbidity Survey. Both scales are assessed at 5- and 30-days post-surgery and assess the recovery after surgery and post-operative adverse events respectively. Feasibility will be evaluated by recording the proportion of potential participants who consent, the proportion of potential participants who engage with each service they are referred to, adherence to physical activity programmes, and the timeliness with which services are delivered relative to referral date. Qualitative feedback will be sought from participants and their families regarding barriers and facilitators to engaging in prehabilitation. This feedback will be sought in semi-structured interviews with the prehabilitation programme coordinator around 1 week after enrolling, on completion of the prehabilitation programme, and around 1 month after surgery.

Sponsors

Auckland District Health Board
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Completed colonoscopy and referred to surgical services.

Exclusion criteria

Cognitive or communication impairment precluding informed consent.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026