Efficacy of Preoperative Prehabilitation With a Home-based Supervised Exercise Program Against an Unsupervised Exercise Program for Frail Elderly Patients Undergoing Major Abdominal Surgery (HOME-PREPARE)
Primary Purpose
Frail Elderly Syndrome, Frailty, Surgery
Status
Recruiting
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Home-based supervised exercise program
Sponsored by
About this trial
This is an interventional treatment trial for Frail Elderly Syndrome focused on measuring prehabilitation
Eligibility Criteria
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
Sites / Locations
- Eileen Yilin SimRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Home supervised exercise program
Home unsupervised exercise program
Arm Description
This group receives standard preoperative physiotherapy education as well a home-exercise instructions. They will also receive 3-4 home visits by physiotherapists between recruitment and surgery, to conduct exercises in their homes.
This group receives standard preoperative physiotherapy education as well a home-exercise instructions.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
30-day in-hospital complications
Classified using the Clavien Dindo Classification
Hospital length-of-stay
Duration that patient stayed in hospital from day of surgery to discharge either to home or step-down care
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.
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.
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.
Maximal Inspiratory Pressure (MIP)
The maximal inspiratory pressure reflects the strength of inspiratory muscles.
30-second and 1-minute Sit-to-Stands (STS)
The Sit to Stand test reflects lower-extremity strength and endurance.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04892368
Brief Title
Efficacy of Preoperative Prehabilitation With a Home-based Supervised Exercise Program Against an Unsupervised Exercise Program for Frail Elderly Patients Undergoing Major Abdominal Surgery
Acronym
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.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Recruiting
Study Start Date
April 10, 2021 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Singapore General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frail Elderly Syndrome, Frailty, Surgery
Keywords
prehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Home supervised exercise program
Arm Type
Active Comparator
Arm Description
This group receives standard preoperative physiotherapy education as well a home-exercise instructions. They will also receive 3-4 home visits by physiotherapists between recruitment and surgery, to conduct exercises in their homes.
Arm Title
Home unsupervised exercise program
Arm Type
No Intervention
Arm Description
This group receives standard preoperative physiotherapy education as well a home-exercise instructions.
Intervention Type
Other
Intervention Name(s)
Home-based supervised exercise program
Intervention Description
Combination of aerobic and strength training exercises, in addition to home exercise instructions issued during preoperative physiotherapy education.
Primary Outcome Measure Information:
Title
Change in functional walking capacity from baseline to just before surgery, as measured using the 6-minute walk distance.
Description
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.
Time Frame
From recruitment to 2-days before surgery
Secondary Outcome Measure Information:
Title
30-day in-hospital complications
Description
Classified using the Clavien Dindo Classification
Time Frame
From day of surgery to 30-days afterwards
Title
Hospital length-of-stay
Description
Duration that patient stayed in hospital from day of surgery to discharge either to home or step-down care
Time Frame
From day of surgery until discharge, or up to 6 months after surgery, whichever occurs first
Title
Health-related quality of life outcomes (HRQoL) as measured using the 12-Item Short Form Survey (SF-12)
Description
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.
Time Frame
Day of recruitment, 2 days before surgery, 4 weeks, 8 weeks and 6 months postoperative
Title
Health-related quality of life outcomes (HRQoL) as measured using the EQ-5D-3L
Description
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.
Time Frame
Day of recruitment, 2 days before surgery, 4 weeks, 8 weeks and 6 months postoperative
Title
Change in 6-minute walking distance
Description
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.
Time Frame
Day of recruitment, 2 days before surgery, 4 weeks and 8 weeks postoperative
Title
Maximal Inspiratory Pressure (MIP)
Description
The maximal inspiratory pressure reflects the strength of inspiratory muscles.
Time Frame
Day of recruitment, 2 days before surgery, 4 weeks and 8 weeks postoperative
Title
30-second and 1-minute Sit-to-Stands (STS)
Description
The Sit to Stand test reflects lower-extremity strength and endurance.
Time Frame
Day of recruitment, 2 days before surgery, 4 weeks and 8 weeks postoperative
Title
Handgrip strength (HGS)
Description
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.
Time Frame
Day of recruitment, 2 days before surgery, 4 weeks and 8 weeks postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eileen Y Sim
Phone
93804422
Email
eileen.sim.y.l@singhealth.com.sg
Facility Information:
Facility Name
Eileen Yilin Sim
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eileen Y Sim
Phone
93804422
Email
eileen.sim.y.l@singhealth.com.sg
First Name & Middle Initial & Last Name & Degree
Hairil Rizal Abdullah, MBBS
First Name & Middle Initial & Last Name & Degree
Eileen Sim, MBBS
First Name & Middle Initial & Last Name & Degree
Chun Ju Tan, Msc
First Name & Middle Initial & Last Name & Degree
Kwong Wei Emile John Tan, MBBS
First Name & Middle Initial & Last Name & Degree
Meihuan Chang, MBBS
First Name & Middle Initial & Last Name & Degree
Jia Lin Ng, MBBS
First Name & Middle Initial & Last Name & Degree
Ee-Lin Toh, MBBS
First Name & Middle Initial & Last Name & Degree
Chung Yip Chang, MBBS
First Name & Middle Initial & Last Name & Degree
Hwee Kuan Ong, DClinPT
First Name & Middle Initial & Last Name & Degree
Eleanor Shuxian Chew, Msc
First Name & Middle Initial & Last Name & Degree
Thiri Naing Thin, BN
First Name & Middle Initial & Last Name & Degree
Pei Yi Brenda Tan, BSc
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of Preoperative Prehabilitation With a Home-based Supervised Exercise Program Against an Unsupervised Exercise Program for Frail Elderly Patients Undergoing Major Abdominal Surgery
We'll reach out to this number within 24 hrs