Clinical trial NCT05977556: 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
Overall status: SUSPENDED
Phase: PHASE1
Conditions: Frailty
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Royal Alexandra Hospital
First posted: 2023-08-04
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change from baseline gait speed at 12 and 24 weeks
timeFrame: 12 and 24 weeks
Secondary outcomes:
measure: Change from baseline physical activity at 12 and 24 weeks
timeFrame: 12 and 24 weeks
measure: Change from baseline sedentary behavior at 12 and 24 weeks
timeFrame: 12 and 24 weeks
measure: Change from baseline sleep at 12 and 24 weeks
timeFrame: 12 and 24 weeks
measure: Change from baseline Timed-Up and Go (TUG) test at 12 and 24 weeks
timeFrame: 12 and 24 weeks
measure: Change from baseline functional lower extremity strength at 12 and 24 weeks
timeFrame: 12 and 24 weeks
measure: Change from baseline hand grip strength at 12 and 24 weeks
timeFrame: 12 and 24 weeks
measure: Change from baseline Barthel Index at 12 and 24 weeks
timeFrame: 12 and 24 weeks
measure: Length of hospital stay after surgery to be determined at 12 and 24 weeks
timeFrame: 12 and 24 weeks
measure: Readmission rate to hospital after discharge to be determined at 12 and 24 weeks
timeFrame: 12 and 24 weeks
measure: Change from baseline Saint Louis University mental status (SLUMS) test
timeFrame: 12 and 24 weeks
measure: Number of participants with reported postoperative complications
timeFrame: 12 and 24 weeks
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital
Study officials:
affiliation: Alberta Health services
name: Naheed Rajabali, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alberta
name: Victor Ezeugwu, PhD
role: PRINCIPAL_INVESTIGATOR
References: