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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04892368
Other study ID # H-PREPARE-01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 10, 2021
Est. completion date December 2023

Study information

Verified date May 2021
Source Singapore General Hospital
Contact Eileen Y Sim
Phone 93804422
Email eileen.sim.y.l@singhealth.com.sg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Singapore's population is ageing, and more elderly people are undergoing elective major surgeries. Frail elderly experience greater functional decline and slower recovery in physical function after surgery compared to non-frail elderly. Preoperative prehabilitation aims to enhance both aerobic capacity and physical strength of elderly to attenuate the post-operative decline in physical function. Singapore General Hospital has a bespoke preoperative program - Prehabilitation for Elderly Frail Patients Undergoing Elective Surgeries (PREPARE), where patients receive physiotherapy education and instructions for home-based unsupervised exercise program (uSEP). A hospital-based supervised exercise program had also been established but the take-up rate was low (7.6%) due to barriers such as cost and accessibility. Perioperative supervised exercise training can effect greater gains in functional capacity and muscle strength compared to no supervision. For the elderly with limited transport options to the hospital, home-based supervised programmes may be more convenient compared to hospital-based supervised programmes, but the former is costlier too. Home-interventions may also empower patients with the skills and confidence to maintain their physical fitness at home, which increases their likelihood of exercising after surgery. The investigators propose a prospective single-center randomized controlled trial to evaluate the efficacy of preoperative prehabilitation with a home-based supervised exercise program (SEP) for frail elderly patients undergoing major abdominal surgery, compared to the mainstay of clinical practice, which is a home-based uSEP.


Recruitment information / eligibility

Status Recruiting
Enrollment 140
Est. completion date December 2023
Est. primary completion date May 2023
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility Inclusion Criteria: - 1. Elective major abdominal surgery - 2. Lead time >= 14 days to surgery - 3. Edmonton Frail Scale total score >= 6 points or Functional performance score (Timed up and Go(TUG)) >= 1 point Exclusion Criteria: - 1. Inability to provide written informed consent due to cognitive impairment - 2. Having Comorbid medical conditions interfering with the ability to perform exercise at home or to complete the testing procedures. These include: i. Unstable cardiac conditions ii. Acute illnesses iii. Patients who are completely unable to walk

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Home-based supervised exercise program
Combination of aerobic and strength training exercises, in addition to home exercise instructions issued during preoperative physiotherapy education.

Locations

Country Name City State
Singapore Eileen Yilin Sim Singapore

Sponsors (1)

Lead Sponsor Collaborator
Singapore General Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in functional walking capacity from baseline to just before surgery, as measured using the 6-minute walk distance. Distance that the patient can walk in 6 min, along a 15-20m hallway, at a pace that the participants will be tired at the end of the distance. This is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. From recruitment to 2-days before surgery
Secondary 30-day in-hospital complications Classified using the Clavien Dindo Classification From day of surgery to 30-days afterwards
Secondary Hospital length-of-stay Duration that patient stayed in hospital from day of surgery to discharge either to home or step-down care From day of surgery until discharge, or up to 6 months after surgery, whichever occurs first
Secondary Health-related quality of life outcomes (HRQoL) as measured using the 12-Item Short Form Survey (SF-12) SF-12 is a 12-item questionnaire that assesses generic health outcomes from the patient's perspective, and covers eight domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional & mental health. Day of recruitment, 2 days before surgery, 4 weeks, 8 weeks and 6 months postoperative
Secondary Health-related quality of life outcomes (HRQoL) as measured using the EQ-5D-3L The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. Day of recruitment, 2 days before surgery, 4 weeks, 8 weeks and 6 months postoperative
Secondary Change in 6-minute walking distance Distance that the patient can walk in 6 min, along a 15-20m hallway, at a pace that the participants will be tired at the end of the distance. This is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. Day of recruitment, 2 days before surgery, 4 weeks and 8 weeks postoperative
Secondary Maximal Inspiratory Pressure (MIP) The maximal inspiratory pressure reflects the strength of inspiratory muscles. Day of recruitment, 2 days before surgery, 4 weeks and 8 weeks postoperative
Secondary 30-second and 1-minute Sit-to-Stands (STS) The Sit to Stand test reflects lower-extremity strength and endurance. Day of recruitment, 2 days before surgery, 4 weeks and 8 weeks postoperative
Secondary Handgrip strength (HGS) The handgrip strength is a measure of muscular strength or the maximum force/tension generated by one's forearm muscles. It reflects upper body strength and overall strength. Day of recruitment, 2 days before surgery, 4 weeks and 8 weeks postoperative
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