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

NCT05977556 | Suspended Phase 1

• 1 other identifier: Pro00122843
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Frailty

Outcome Measures

Primary Outcomes (1)

• Change from baseline gait speed at 12 and 24 weeks

  Comfortable walking speed will be assessed over a 5-meter walkway

  12 and 24 weeks

Secondary Outcomes (11)

• Change from baseline physical activity at 12 and 24 weeks

  12 and 24 weeks

• Change from baseline sedentary behavior at 12 and 24 weeks

  12 and 24 weeks

• Change from baseline sleep at 12 and 24 weeks

  12 and 24 weeks

• Change from baseline Timed-Up and Go (TUG) test at 12 and 24 weeks

  12 and 24 weeks

• Change from baseline functional lower extremity strength at 12 and 24 weeks

  12 and 24 weeks

Study Arms (2)

Experimental

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.

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

Standard of care

NO INTERVENTION

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

Interventions

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

Experimental

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unstable medical conditions that limit exercise tolerance such as ME/CFS

Sponsors & Collaborators

• University of Alberta: lead
• Royal Alexandra Hospital: collaborator

Study Sites (1)

Royal Alexandra Hospital

Edmonton, Canada

Location

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Naheed Rajabali, MD

  Alberta Health services

  PRINCIPAL INVESTIGATOR

• Victor Ezeugwu, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: August 4, 2023
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)