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

NCT ID: NCT05977556

Last Updated: 2025-03-04

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2028-03-31

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.

Conditions

Frailty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Experimental

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.

Group Type: EXPERIMENTAL

Combined neuromuscular exercise training and 'sit less, move more' program

Intervention Type: BEHAVIORAL

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.

Standard of care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Combined neuromuscular exercise training and 'sit less, move more' program

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Royal Alexandra Hospital

OTHER

Sponsor Role: collaborator

University of Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Naheed Rajabali, MD

Role: PRINCIPAL_INVESTIGATOR

Alberta Health services

Victor Ezeugwu, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

Royal Alexandra Hospital

Edmonton, , Canada

Countries

Canada

Other Identifiers

Pro00122843

Identifier Type: -

Identifier Source: org_study_id