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The PREPARE Trial: Exercise Before Surgery to Improve Recovery in Older People With Frailty

Primary Purpose

Frailty, Surgery--Complications, Disability Physical

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Exercise Group
Sponsored by
Ottawa Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Frailty

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 60 years of age or older
  • Elective surgery with expected post-surgery stay of 2 days or more.
  • Frailty present (Clinical Frailty Scale (CFS) score of 4/9 or greater)
  • Surgery date between 3 and 12 weeks from enrollment

Exclusion Criteria:

  • Inability to communicate in English or in French
  • Unreachable by telephone
  • Palliative surgery
  • Cardiac, neurological or orthopedic procedures.

Sites / Locations

  • The Ottawa HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise Group

Control Group

Arm Description

The intervention is a home-based, multimodal exercise prehabilitation program. Exercise is prescribed in one-hour sessions, performed a minimum of three times per week for three weeks, consisting of: 1) strength training, 2) aerobic exercise and 3) flexibility. The intervention group will receive weekly phone calls to gauge adherence, suggest modifications, provide support and track any adverse events.

The control group will receive the World Health Organization recommendations for physical activity for people greater or equal to the age of 65 years old pamphlet, as well as a guide to healthy eating for older adults.

Outcomes

Primary Outcome Measures

In-hospital complications
The Postoperative Morbidity Survey (POMS), will be used to define complications. Individuals experiencing any POMS complication or dying in hospital will be said to have experienced a complication.
Patient-reported disability 30 days after surgery
The World Health Organization Disability Assessment Schedule 2.0 (WHODAS) will be used . It is a patient-reported disability scale that assesses limitations in six major life domains - cognition, mobility, self-care, social interaction, life activities and participation in society. Participants will report if they have had no difficulty, mild difficulty, moderate difficulty, severe difficulty or extreme difficulty (simply cannot do) with the items listed.

Secondary Outcome Measures

Function - Timed Up and Go Test
The Timed Up and Go Test will be used for measuring the risk of falls in older adults.
Function - Daily and total step count
Daily and total step counts will be measured, which will predict adverse post-hospitalization outcomes and will reflect physical recovery. They will be recorded daily for the duration of the exercise program (for those in the exercise group) and 30 days after surgery (for all participants) to evaluate functional recovery.
Function - Katz Index of Activities of Daily Living
The Katz Index measures function in activities of daily living (ADL). The ADLs examined are bathing, dressing, toileting, transferring, continence and feeding. If a person is able to perform the ADL independently, they receive 1 point for that activity. If a person is dependent on others to perform the ADL, they receive 0 points for that activity. A score of 6 is high, meaning the person is independent whereas a score of 0 is low, indicating that the person is very dependent.
Function - Falls
Falls will be documented as a way of assessing function.
Health-related quality of life
EQ-5D EuroQuoL will be used to measure health-related quality of life at baseline, 30, 90 and 365 days after surgery and to inform incremental cost per quality-adjusted life year gained. Participants are asked to select one answer under each domain (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Responses range from having no problems with a particular domain to being unable to engage in that particular domain. Finally, participants are asked to identify on a scale of 0-100 how good or bad their health is on that given day (0 being worst health they can imagine, 100 being best health they can imagine).
All-cause mortality
All deaths and death dates will be identified in-hospital or through telephone follow-up.
Health System - Discharge position
Assess where the participant will be discharged to once out of hospital.
Health System - Hospital re-admissions
Participants will be asked during the 30 day, 90 day and one-year follow-up calls if they have been readmitted to hospital since hospital discharge.
Health System - Emergency department visits
Participants will be asked during the 30 day, 90 day and one-year follow-up calls if they had any emergency department visits since hospital discharge.
Health System - Long-term care admissions
Participants will be asked during the 30 day, 90 day and one-year follow-up calls if they were admitted to a long-term care facility.
Participant Feedback
A theoretical domains framework participant survey will identify barriers and facilitators to participation in the exercise group. Responses are on a five-point likert scale ranging from "strongly disagree" to "strongly agree", or "never" to "always" depending on the question asked.
Safety (Adverse Events)
Falls, cardiac or respiratory complications and unplanned healthcare encounters will be collected during the exercise treatment period for the exercise group. For the control group, participants will be asked if they experienced any falls since the time of enrollment up until the day before surgery. Safety data will also be collected should any adverse event take place during any physical assessment data collection time point. Unplanned healthcare encounters will also be collected during the time of enrollment to the day before surgery for the intervention group through chart review.

Full Information

First Posted
December 2, 2019
Last Updated
October 12, 2023
Sponsor
Ottawa Hospital Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04221295
Brief Title
The PREPARE Trial: Exercise Before Surgery to Improve Recovery in Older People With Frailty
Official Title
PREPARE Trial: a Parallel Arm Multicenter Randomized Trial of Frailty-focused PReoperative Exercise to Decrease PostoperAtive Complications Rates and Disability scorEs
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 24, 2020 (Actual)
Primary Completion Date
February 2, 2024 (Anticipated)
Study Completion Date
February 2, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study evaluates whether participating in a home-based exercise program leads to lower levels of complication rates and patient-reported disability after surgery. Half of the participants will be randomized into the exercise group, while the other half will be randomized into the control group.
Detailed Description
Background: Four out of ten older people having surgery live with frailty, leaving them vulnerable to adverse outcomes due to accumulation of age- and disease-related deficits. An increasing number of people with frailty require surgery. Frailty is associated with a >2-fold increase in complications and new patient-reported disability; absolute rates are >50% and 20% respectively; physical and physiologic deficits are particularly implicated. Mortality, costs and institutionalization after surgery are also significantly associated with frailty. Despite frailty's strong association with adverse outcomes, few perioperative trials include older people with frailty. Exercise therapy may improve function and decrease complications for other people with frailty by addressing physical and physiologic deficits. However, existing trials are small (median n=54) and single center. Most interventions have been resource-intensive, requiring attendance at hospital-based sessions, which may limit access to many who could benefit. Patient-reported outcomes are also lacking. Therefore, a multicenter trial of home-based exercise therapy before surgery for older people with frailty, powered to address patient-reported outcomes, is needed. Our trial will address these knowledge gaps by testing the effectiveness of home-based preoperative exercise (exercise prehabilitation) in decreasing patient-reported disability and postoperative complications in older people with frailty having major surgery. Research aims: Estimate the effectiveness of exercise prehabilitation on: Co-primary outcomes: patient-reported disability 30-days after surgery and in-hospital complications Secondary outcomes: patient-centered (discharge home, survival, 30, 90 and one-year disability scores, quality of life, function) and system-relevant (length of stay, admissions) Health economic outcomes: costs, cost-effectiveness Methods: Design, setting and participants: Parallel-arm multicenter randomized controlled trial at 14 Canadian hospitals. People => 60 years old with frailty (Clinical Frailty Scale score of 4/9) having major elective non-cardiac surgery (vascular, intrathoracic, intraabdominal, pelvic, ENT) with expected length of stay of => 2 days will be included. Intervention: Home-based exercise program with demonstrated efficacy, feasibility and acceptability tailored for people with frailty. Outcomes and sample size: Co-primary outcomes are patient-reported disability 30 days after surgery (validated WHODAS tool) and prospectively collected in-hospital complications (validated POMS tool). 750 participants (375/arm) will provide 98% power for disability (control mean score 35 (SD 25; MID=8)) and 90% power for complications (55% complication rate (25% relative risk reduction)) (α=0.025; 2 pair-wise comparisons). Expertise: Our team features multidisciplinary clinical and methodological experts, nationally representative knowledge users and patient representatives. Expected outcomes: Older people with frailty are a growing and vulnerable segment of the surgical population and are under-represented in existing studies. Exercise prehabilitation is a high-priority research question which may be most relevant to people with frailty given their physical and physiologic vulnerabilities. This study, featuring patient-reported outcomes and an integrated knowledge translation approach will produce generalizable findings directly relevant to patients, families, caregivers, and knowledge users.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty, Surgery--Complications, Disability Physical

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Group allocation will not be indicated in data analyzed by the outcome assessors.
Allocation
Randomized
Enrollment
850 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise Group
Arm Type
Experimental
Arm Description
The intervention is a home-based, multimodal exercise prehabilitation program. Exercise is prescribed in one-hour sessions, performed a minimum of three times per week for three weeks, consisting of: 1) strength training, 2) aerobic exercise and 3) flexibility. The intervention group will receive weekly phone calls to gauge adherence, suggest modifications, provide support and track any adverse events.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The control group will receive the World Health Organization recommendations for physical activity for people greater or equal to the age of 65 years old pamphlet, as well as a guide to healthy eating for older adults.
Intervention Type
Behavioral
Intervention Name(s)
Exercise Group
Intervention Description
Previously described in the arm/group descriptions.
Primary Outcome Measure Information:
Title
In-hospital complications
Description
The Postoperative Morbidity Survey (POMS), will be used to define complications. Individuals experiencing any POMS complication or dying in hospital will be said to have experienced a complication.
Time Frame
up to 30 days.
Title
Patient-reported disability 30 days after surgery
Description
The World Health Organization Disability Assessment Schedule 2.0 (WHODAS) will be used . It is a patient-reported disability scale that assesses limitations in six major life domains - cognition, mobility, self-care, social interaction, life activities and participation in society. Participants will report if they have had no difficulty, mild difficulty, moderate difficulty, severe difficulty or extreme difficulty (simply cannot do) with the items listed.
Time Frame
Assessing change in score from baseline data collection to 30 days post-op
Secondary Outcome Measure Information:
Title
Function - Timed Up and Go Test
Description
The Timed Up and Go Test will be used for measuring the risk of falls in older adults.
Time Frame
Assessing change in score from baseline data collection up to 30 days post-op.
Title
Function - Daily and total step count
Description
Daily and total step counts will be measured, which will predict adverse post-hospitalization outcomes and will reflect physical recovery. They will be recorded daily for the duration of the exercise program (for those in the exercise group) and 30 days after surgery (for all participants) to evaluate functional recovery.
Time Frame
Assessing the difference in daily and total step count between the exercise group and control group for 30 days post-op.
Title
Function - Katz Index of Activities of Daily Living
Description
The Katz Index measures function in activities of daily living (ADL). The ADLs examined are bathing, dressing, toileting, transferring, continence and feeding. If a person is able to perform the ADL independently, they receive 1 point for that activity. If a person is dependent on others to perform the ADL, they receive 0 points for that activity. A score of 6 is high, meaning the person is independent whereas a score of 0 is low, indicating that the person is very dependent.
Time Frame
Assessing change in the participants KATZ ADL score from baseline to post-op day 3, 5, 7 and up to 30 days.
Title
Function - Falls
Description
Falls will be documented as a way of assessing function.
Time Frame
Assessing the difference in the occurrence of falls between the exercise group and control group on day 3, 5, 7, up to 30 days, as well as 30-day, 90-day and one-year after surgery.
Title
Health-related quality of life
Description
EQ-5D EuroQuoL will be used to measure health-related quality of life at baseline, 30, 90 and 365 days after surgery and to inform incremental cost per quality-adjusted life year gained. Participants are asked to select one answer under each domain (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Responses range from having no problems with a particular domain to being unable to engage in that particular domain. Finally, participants are asked to identify on a scale of 0-100 how good or bad their health is on that given day (0 being worst health they can imagine, 100 being best health they can imagine).
Time Frame
Assessing any change from baseline to 30, 90 and 365 days post-op.
Title
All-cause mortality
Description
All deaths and death dates will be identified in-hospital or through telephone follow-up.
Time Frame
30, 90, and 365 days.
Title
Health System - Discharge position
Description
Assess where the participant will be discharged to once out of hospital.
Time Frame
Up to 30 days post-op.
Title
Health System - Hospital re-admissions
Description
Participants will be asked during the 30 day, 90 day and one-year follow-up calls if they have been readmitted to hospital since hospital discharge.
Time Frame
30, 90, and 365 days post-op via telephone
Title
Health System - Emergency department visits
Description
Participants will be asked during the 30 day, 90 day and one-year follow-up calls if they had any emergency department visits since hospital discharge.
Time Frame
30, 90, and 365 days post-op via telephone
Title
Health System - Long-term care admissions
Description
Participants will be asked during the 30 day, 90 day and one-year follow-up calls if they were admitted to a long-term care facility.
Time Frame
30, 90, and 365 days post-op via telephone
Title
Participant Feedback
Description
A theoretical domains framework participant survey will identify barriers and facilitators to participation in the exercise group. Responses are on a five-point likert scale ranging from "strongly disagree" to "strongly agree", or "never" to "always" depending on the question asked.
Time Frame
Participants are asked to reflect on the program during a call the day before surgery.
Title
Safety (Adverse Events)
Description
Falls, cardiac or respiratory complications and unplanned healthcare encounters will be collected during the exercise treatment period for the exercise group. For the control group, participants will be asked if they experienced any falls since the time of enrollment up until the day before surgery. Safety data will also be collected should any adverse event take place during any physical assessment data collection time point. Unplanned healthcare encounters will also be collected during the time of enrollment to the day before surgery for the intervention group through chart review.
Time Frame
Assessing frequency of, or change in any safety events from enrollment up to 30 days post-op in hospital between the exercise group and control group.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 60 years of age or older Elective surgery with expected post-surgery stay of 2 days or more. Frailty present (Clinical Frailty Scale (CFS) score of 4/9 or greater) Surgery date between 3 and 12 weeks from enrollment Exclusion Criteria: Inability to communicate in English or in French Unreachable by telephone Palliative surgery Cardiac, neurological or orthopedic procedures.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karina Branje
Phone
613-798-5555
Ext
79322
Email
kbranje@ohri.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel I McIsaac, MD,MPH,FRCPC
Organizational Affiliation
The Ottawa Hospital Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Hladkowicz
Phone
613-798-5555
Ext
18629
Email
emhladkowicz@toh.ca
First Name & Middle Initial & Last Name & Degree
Daniel I McIsaac, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data, including data dictionaries, will be available. This includes individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). The Study Protocol, Statistical Analysis Plan and Informed Consent Form will also be made available. Data will be available beginning 3 months and ending 5 years following article publication of one year follow up data. Data will be shared with researchers who provide a methodologically sound proposal. Data can be used to achieve aims in a proposed proposal or for individual participant data meta-analysis. Proposals should be directed to dmcisaac@toh.ca. To gain access, data requestors will need to sign a data access agreement. Data will be shared via an appropriate 3rd party website that is consistent with ethical and health privacy compliant legislation at the time of study conclusion.
IPD Sharing Time Frame
Data will be available beginning 3 months and ending 5 years following article publication of one year follow up data.
IPD Sharing Access Criteria
Data will be shared with researchers who provide a methodologically sound proposal. Data can be used to achieve aims in a proposed proposal or for individual participant data meta-analysis. Proposals should be directed to dmcisaac@toh.ca. To gain access, data requestors will need to sign a data access agreement. Data will be shared via an appropriate 3rd party website that is consistent with ethical and health privacy compliant legislation at the time of study conclusion.
Citations:
PubMed Identifier
35940835
Citation
McIsaac DI, Fergusson DA, Khadaroo R, Meliambro A, Muscedere J, Gillis C, Hladkowicz E, Taljaard M; PREPARE Investigators. PREPARE trial: a protocol for a multicentre randomised trial of frailty-focused preoperative exercise to decrease postoperative complication rates and disability scores. BMJ Open. 2022 Aug 8;12(8):e064165. doi: 10.1136/bmjopen-2022-064165.
Results Reference
derived

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The PREPARE Trial: Exercise Before Surgery to Improve Recovery in Older People With Frailty

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