Efficacy of Preoperative Prehabilitation With a Home-based Supervised Exercise Program Against an Unsupervised Exercise Program for Frail Elderly Patients Undergoing Major Abdominal Surgery

Surgery Clinical Trial

— HOME-PREPARE  

Official title:

Prospective Single-centre Randomized Controlled Trial to Evaluate Preoperative Home-based Supervised Exercise Program for Prehabilitation of Frail Elderly Patients Undergoing Major Abdominal Surgery, Against Current Home-based Unsupervised Exercise Program.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04892368
• Other study ID #: H-PREPARE-01
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Frail Elderly Syndrome
• Frailty
• Surgery

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