Prehabilitation of Frail Patients undergoing Elective Colorectal Surgery – a feasibility pilot study

Not Applicable

• Conditions: Colorectal cancer; Colorectal surgery; Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation; Cancer - Bowel - Back passage (rectum) or large bowel (colon); Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12616000021471
• Lead Sponsor: Dr Siva Senthuran

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-01-14
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Patients undergoing all major colorectal surgery (both cancer and non cancer)
Frail or Prefrail by Edmonton Frail Scale (>3 criteria)
Residents capable of attending training & assessments.

Exclusion Criteria

Emergent or Urgent Surgery (<30 days wait)

Contraindications to Prehabilitation such as:
- Unstable Angina
- Resting Systolic BP>200 or Diastolic BP>110
- Orthostatic BP drop >20mmHg
- Critical aortic stenosis (Peak systolic pressure gradient >50mmHg with an aortic valve orifice area <0.75cm2 in average adult)
- Acute systemic illness or fever
- Uncontrolled Atrial or Ventricular arrhythmias
- Uncontrolled Sinus tachycardia
- Uncompensated congestive heart failure
- 3rd Degree AV Block (without pacemaker)
- Active Pericarditis or Myocarditis
- Recent Thromboembolism
- Uncontrolled Diabetes (Resting BSL >22mmol)
- Other metabolic conditions e.g. acute thyroiditis

Severe Orthopaedic conditions prohibiting exercise
Inability to speak English or has documented learning impairment

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Aerobic capacity or exercise tolerance, assessed by 6 minute walk distance (6MWD)[Baseline, pre-operation and ~30 days follow-up.]

Secondary Outcome Measures

Name	Time	Method
Quality of life via EQ5D & Short Form-12.[Baseline, pre-operation and ~30 days follow-up.];Physical activity levels (sitting, standing, walking time by accelerometry)[Baseline, pre-operation and ~30 days follow-up.];Lower body function assessed by Short Physical Performance Battery[Baseline, pre-operation and ~30 days follow-up];Incidence of and type of adverse events assessed by patient diary and review of hospital records[Baseline, pre-operation and ~30 days follow-up];Hospital length of stay assessed by review of hospital records<br>[Baseline, pre-operation and ~30 days follow-up];Re-admissions to hospital assessed by review of hospital records[Baseline, pre-operation and ~30 days follow-up];Number of Postoperative Complications (via Dindo Clavien Classification) assessed by review of hospital records[Baseline, pre-operation and ~30 days follow-up];Care dependence (via modified Barthel Index) & need for rehabilitation assessed by review of hospital records[Baseline, pre-operation and ~30 days follow-up]