Frail Elderly SyndromeHOME-PREPARENCT04892368
Efficacy of Preoperative Prehabilitation With a Home-based Supervised Exercise Program Against an Unsupervised Exercise Program for Frail Elderly Patients Undergoing Major Abdominal Surgery
A study testing Home-based supervised exercise program in people with Frail Elderly Syndrome and Frailty, run by Singapore General Hospital at 1 site in Singapore.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Frail Elderly Syndrome, Frailty, Surgery
- What is being tested?
- Home-based supervised exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteSingapore
- Study dates
- 10 Apr 2021to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Eileen Yilin Sim
Singapore, 169608
Eileen Y Sim, 93804422, eileen.sim.y.l@singhealth.com.sg
Hairil Rizal Abdullah, MBBS
About this study
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.
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.
- Conditions
- Frail Elderly Syndrome, Frailty, Surgery
- Being tested
- Home-based supervised exercise program
- Keywords
- prehabilitation
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based supervised exercise programOther
Combination of aerobic and strength training exercises, in addition to home exercise instructions issued during preoperative physiotherapy education.
| Study group | Role | What they receive |
|---|---|---|
| Home supervised exercise program | Active comparator | 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. Receives: Other: Home-based supervised exercise program |
| Home unsupervised exercise program | No intervention | This group receives standard preoperative physiotherapy education as well a home-exercise instructions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From recruitment to 2-days before surgery
Secondary outcomes (8)
30-day in-hospital complications
Classified using the Clavien Dindo Classification
Measured: From day of surgery to 30-days afterwards
Hospital length-of-stay
Duration that patient stayed in hospital from day of surgery to discharge either to home or step-down care
Measured: From day of surgery until discharge, or up to 6 months after surgery, whichever occurs first
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.
Measured: Day of recruitment, 2 days before surgery, 4 weeks, 8 weeks and 6 months postoperative
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.
Measured: Day of recruitment, 2 days before surgery, 4 weeks, 8 weeks and 6 months postoperative
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.
Measured: Day of recruitment, 2 days before surgery, 4 weeks and 8 weeks postoperative
Maximal Inspiratory Pressure (MIP)
The maximal inspiratory pressure reflects the strength of inspiratory muscles.
Measured: Day of recruitment, 2 days before surgery, 4 weeks and 8 weeks postoperative
30-second and 1-minute Sit-to-Stands (STS)
The Sit to Stand test reflects lower-extremity strength and endurance.
Measured: Day of recruitment, 2 days before surgery, 4 weeks and 8 weeks postoperative
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.
Measured: Day of recruitment, 2 days before surgery, 4 weeks and 8 weeks postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start10 Apr 2021
- Primary completionMay 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frail Elderly SyndromeStudies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04892368
- Sponsor's protocol ID
- H-PREPARE-01
- Acronym
- HOME-PREPARE
- Status last verified
- May 2021
- First submitted
- 4 May 2021
- Last updated
- 2 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04892368
- Acronym / sponsor ID
- HOME-PREPARE / H-PREPARE-01
- Conditions
- Frail Elderly Syndrome, Frailty, Surgery
- Keywords
- prehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- 10 Apr 2021 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 19 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home supervised exercise program | Active comparator | Other: Home-based supervised exercise programThis 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. |
| Home unsupervised exercise program | No intervention | –This group receives standard preoperative physiotherapy education as well a home-exercise instructions. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based supervised exercise programCombination of aerobic and strength training exercises, in addition to home exercise instructions issued during preoperative physiotherapy education. | Other | Home supervised exercise program |
Primary outcome
Change in functional walking capacity from baseline to just before surgery, as measured using the 6-minute walk distance.
Time frame: From recruitment to 2-days before surgery
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.
8 secondary outcomes
30-day in-hospital complications
Time frame: From day of surgery to 30-days afterwards
Hospital length-of-stay
Time frame: From day of surgery until discharge, or up to 6 months after surgery, whichever occurs first
Health-related quality of life outcomes (HRQoL) as measured using the 12-Item Short Form Survey (SF-12)
Time frame: Day of recruitment, 2 days before surgery, 4 weeks, 8 weeks and 6 months postoperative
Health-related quality of life outcomes (HRQoL) as measured using the EQ-5D-3L
Time frame: Day of recruitment, 2 days before surgery, 4 weeks, 8 weeks and 6 months postoperative
Change in 6-minute walking distance
Time frame: Day of recruitment, 2 days before surgery, 4 weeks and 8 weeks postoperative
Maximal Inspiratory Pressure (MIP)
Time frame: Day of recruitment, 2 days before surgery, 4 weeks and 8 weeks postoperative
30-second and 1-minute Sit-to-Stands (STS)
Time frame: Day of recruitment, 2 days before surgery, 4 weeks and 8 weeks postoperative
Handgrip strength (HGS)
Time frame: Day of recruitment, 2 days before surgery, 4 weeks and 8 weeks postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based supervised exercise program in people with Frail Elderly Syndrome and Frailty, run by Singapore General Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eileen Y Sim (93804422, eileen.sim.y.l@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in functional walking capacity from baseline to just before surgery, as measured using the 6-minute walk distance. (time frame: From recruitment to 2-days before surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2021.