Ignite Creation Date:
2024-05-06 @ 7:20 PM
Last Modification Date:
2024-10-26 @ 3:05 PM
Study NCT ID:
NCT05977556
Status:
SUSPENDED
Last Update Posted:
2024-02-15
First Post:
2023-07-18
Brief Title:
Perioperative Prehabilitation on Markers of Fitness and Frailty in Patients Undergoing Elective Surgery
Sponsor:
Victor Ezeugwu
Organization:
University of Alberta
Study Overview
Official Title:
The Effect of Perioperative Prehabilitation on Markers of Fitness and Frailty in Patients Undergoing Elective Surgery a Pilot Pragmatic Randomized Controlled Trial
Status:
SUSPENDED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
There is another related study that is currently ongoing that would contaminate the control arm
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A growing body of evidence suggests that patients who receive good perioperative care ie 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 ie 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
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 Weightresistancestrength 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 n25 or control n25 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
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 n25 or control n25 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None