search
Back to results

Perioperative Prehabilitation on Markers of Fitness and Frailty in Patients Undergoing Elective Surgery

Primary Purpose

Frailty

Status
Not yet recruiting
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Combined neuromuscular exercise training and 'sit less, move more' program
Sponsored by
Victor Ezeugwu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Frailty

Eligibility Criteria

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

Inclusion Criteria: 50 years of age or older score of 4-6 (vulnerable, mildly or moderately frail) on the clinical frailty scale (CFS) scheduled for elective surgery ambulatory (indoor and/or outdoor) with or without gait aids Exclusion Criteria: Unstable medical conditions that limit exercise tolerance such as ME/CFS

Sites / Locations

  • Royal Alexandra Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental

Standard of care

Arm Description

Neuromuscular strength training: The experimental group will receive up to 24 sessions of neuromuscular strength training led by a physical therapist with expertise in geriatrics and movement behaviors. The program includes exercises such as pelvic lifts, lunges, step-ups, squats, and sit-stands. The difficulty level will progressively increase using techniques like manual resistance, dumbbells, and unstable surfaces. Sedentary behavior intervention: The experimental group will also undergo a sedentary behavior intervention based on social cognitive theory. It involves weekly coaching sessions to enhance self-efficacy in reducing sedentary time and increasing light-intensity activity throughout the day. Participants will be provided with a wrist-worn Fitbit activity monitor for daily feedback and to track adherence to the intervention. The aim is to encourage participants to "sit less and move more" throughout their waking hours.

The control group will receive standard of care that is provided as part of the perioperative surgical procedure and subsequent rehabilitation.

Outcomes

Primary Outcome Measures

Change from baseline gait speed at 12 and 24 weeks
Comfortable walking speed will be assessed over a 5-meter walkway

Secondary Outcome Measures

Change from baseline physical activity at 12 and 24 weeks
Activpal-derived time spent per day in physical activity
Change from baseline sedentary behavior at 12 and 24 weeks
Activpal-derived time spent per day in sedentary behavior
Change from baseline sleep at 12 and 24 weeks
Activpal-derived time spent per day in sleep
Change from baseline Timed-Up and Go (TUG) test at 12 and 24 weeks
Functional mobility will be assessed using the TUG test
Change from baseline functional lower extremity strength at 12 and 24 weeks
Lower extremity strength will be measured using the 30 seconds sit-stand test
Change from baseline hand grip strength at 12 and 24 weeks
Grip strength will be assessed using a dynamometer
Change from baseline Barthel Index at 12 and 24 weeks
Level of independence in activities of daily living (ADL) will be assessed using Barthel Index
Length of hospital stay after surgery to be determined at 12 and 24 weeks
We will determine the length of stay in the hospital
Readmission rate to hospital after discharge to be determined at 12 and 24 weeks
We will determine the hospital readmissions rate within 30 days of discharge.
Change from baseline Saint Louis University mental status (SLUMS) test
Cognitive assessment will be completed using the SLUMS test
Number of participants with reported postoperative complications
We will determine the number of participants with postoperative complications

Full Information

First Posted
July 18, 2023
Last Updated
July 26, 2023
Sponsor
Victor Ezeugwu
Collaborators
Royal Alexandra Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05977556
Brief Title
Perioperative Prehabilitation on Markers of Fitness and Frailty in Patients Undergoing Elective Surgery
Official Title
The Effect of Perioperative Prehabilitation on Markers of Fitness and Frailty in Patients Undergoing Elective Surgery: a Pilot, Pragmatic, Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Victor Ezeugwu
Collaborators
Royal Alexandra 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
A growing body of evidence suggests that patients who receive good perioperative care (i.e. care prior to surgery, during surgery, and after surgery) tend to have fewer complications, quicker recovery times, and shorter hospital stays. A key component of good perioperative care is recognizing individuals who have diminished physiological reserves (i.e. those who are vulnerable or frail). The stress of an invasive procedure can exhaust the diminished reserves of patients who are frail, which can in turn lead to perioperative complications, mortality and an increase burden to the healthcare system. Early interventions in patients with diminished reserves can be applied to reduce the risk of complications and poor outcomes. There are emerging studies that show promising benefits of perioperative interventions, such as prehabilitation, though with some mixed findings. Exercise has been shown to reverse or modify the molecular driving factors of frailty, which involve dysregulation of cytokine and endocrine pathways. Physical inactivity and prolonged sedentary behaviors are also emerging concerns in frailty because of the implicated deleterious health effects. Sedentary behaviors are associated with prevalence and severity of frailty. Among pre-frail and frail inactive adults, sedentary time is associated with higher mortality. Increasing physical activity is recommended as the most feasible approach to prevent and treat frailty. The aim of this study is to determine if a prehabilitation intervention that combines neuromuscular strength training and intervention to reduce sedentary behavior reduces complications, length of stay, and patient recovery, thereby also reducing the burden on the healthcare system.
Detailed Description
Frailty is a complex syndrome associated with poor health outcomes in adults, independent of chronological age. Early identification and management of frailty can help improve outcomes and quality of life. Physical activity and exercise interventions, including strength training, have been recommended to manage frailty. Prehabilitation, a preventive intervention before a process of care, has shown promise but with mixed findings. Weight/resistance/strength training and reducing sedentary behavior are important components in frailty management. Sedentary behavior is associated with higher mortality in frail adults. Increasing physical activity may be helpful in preventing and treating frailty. We aim to test a prehabilitation program combining neuromuscular exercise and sedentary behavior intervention in frail adults undergoing elective surgery. Objective: To evaluate the effect of a 12-week prehabilitation program that combines muscular strengthening exercise with reducing sedentary behaviour for patients 50 years of age or older with frailty undergoing elective surgery. Hypothesis: The main hypothesis is that the combined prehabilitation program will improve postoperative recovery and reduce the risk of adverse outcomes following elective surgery by improving frailty levels. Methods: Fifty adults who are vulnerable, mildly, or moderately frail score of 4-6 on the Clinical Frailty Scale (CFS) will be randomly assigned to either the experimental (n=25) or control (n=25) group. The experimental group will receive up to 24 sessions of neuromuscular strength training delivered twice a week over a 12-week period combined with an intervention to reduce and frequently interrupt sedentary behavior. The control group will receive standard of care that is provided as part of the perioperative surgical procedure and subsequent rehabilitation. The "usual care" comparator arm appears to be an appropriate option for a pilot pragmatic study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
Neuromuscular strength training: The experimental group will receive up to 24 sessions of neuromuscular strength training led by a physical therapist with expertise in geriatrics and movement behaviors. The program includes exercises such as pelvic lifts, lunges, step-ups, squats, and sit-stands. The difficulty level will progressively increase using techniques like manual resistance, dumbbells, and unstable surfaces. Sedentary behavior intervention: The experimental group will also undergo a sedentary behavior intervention based on social cognitive theory. It involves weekly coaching sessions to enhance self-efficacy in reducing sedentary time and increasing light-intensity activity throughout the day. Participants will be provided with a wrist-worn Fitbit activity monitor for daily feedback and to track adherence to the intervention. The aim is to encourage participants to "sit less and move more" throughout their waking hours.
Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
The control group will receive standard of care that is provided as part of the perioperative surgical procedure and subsequent rehabilitation.
Intervention Type
Behavioral
Intervention Name(s)
Combined neuromuscular exercise training and 'sit less, move more' program
Intervention Description
Neuromuscular strength training: The experimental group will receive up to 24 sessions of neuromuscular strength training led by a physical therapist with expertise in geriatrics and movement behaviors. The program includes exercises such as pelvic lifts, lunges, step-ups, squats, and sit-stands. The difficulty level will progressively increase using techniques like manual resistance, dumbbells, and unstable surfaces. Sedentary behavior intervention: The experimental group will also undergo a sedentary behavior intervention based on social cognitive theory. It involves weekly coaching sessions to enhance self-efficacy in reducing sedentary time and increasing light-intensity activity throughout the day. Participants will be provided with a wrist-worn Fitbit activity monitor for daily feedback and to track adherence to the intervention. The aim is to encourage participants to "sit less and move more" throughout their waking hours.
Primary Outcome Measure Information:
Title
Change from baseline gait speed at 12 and 24 weeks
Description
Comfortable walking speed will be assessed over a 5-meter walkway
Time Frame
12 and 24 weeks
Secondary Outcome Measure Information:
Title
Change from baseline physical activity at 12 and 24 weeks
Description
Activpal-derived time spent per day in physical activity
Time Frame
12 and 24 weeks
Title
Change from baseline sedentary behavior at 12 and 24 weeks
Description
Activpal-derived time spent per day in sedentary behavior
Time Frame
12 and 24 weeks
Title
Change from baseline sleep at 12 and 24 weeks
Description
Activpal-derived time spent per day in sleep
Time Frame
12 and 24 weeks
Title
Change from baseline Timed-Up and Go (TUG) test at 12 and 24 weeks
Description
Functional mobility will be assessed using the TUG test
Time Frame
12 and 24 weeks
Title
Change from baseline functional lower extremity strength at 12 and 24 weeks
Description
Lower extremity strength will be measured using the 30 seconds sit-stand test
Time Frame
12 and 24 weeks
Title
Change from baseline hand grip strength at 12 and 24 weeks
Description
Grip strength will be assessed using a dynamometer
Time Frame
12 and 24 weeks
Title
Change from baseline Barthel Index at 12 and 24 weeks
Description
Level of independence in activities of daily living (ADL) will be assessed using Barthel Index
Time Frame
12 and 24 weeks
Title
Length of hospital stay after surgery to be determined at 12 and 24 weeks
Description
We will determine the length of stay in the hospital
Time Frame
12 and 24 weeks
Title
Readmission rate to hospital after discharge to be determined at 12 and 24 weeks
Description
We will determine the hospital readmissions rate within 30 days of discharge.
Time Frame
12 and 24 weeks
Title
Change from baseline Saint Louis University mental status (SLUMS) test
Description
Cognitive assessment will be completed using the SLUMS test
Time Frame
12 and 24 weeks
Title
Number of participants with reported postoperative complications
Description
We will determine the number of participants with postoperative complications
Time Frame
12 and 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 50 years of age or older score of 4-6 (vulnerable, mildly or moderately frail) on the clinical frailty scale (CFS) scheduled for elective surgery ambulatory (indoor and/or outdoor) with or without gait aids Exclusion Criteria: Unstable medical conditions that limit exercise tolerance such as ME/CFS
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Victor E. Ezeugwu, PhD
Phone
7804925108
Email
ezeugwu@ualberta.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Ritika Sharma
Email
ritika8@ualberta.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naheed Rajabali, MD
Organizational Affiliation
Alberta Health services
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Victor Ezeugwu, PhD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Alexandra Hospital
City
Edmonton
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Perioperative Prehabilitation on Markers of Fitness and Frailty in Patients Undergoing Elective Surgery

We'll reach out to this number within 24 hrs