Clinical Trials Logo

Clinical Trial Summary

A novel prehabilitation method has been implemented at our institution to decrease perioperative outcome complications for frail complex spine fusion surgery patients. The goal of this randomized trial is to evaluate whether this prehabilitation program improves preoperative functional status of frail spine disease patients and benefits patients in their postsurgical outcomes.


Clinical Trial Description

Background: Patients with degenerative lumbar spine disease who are candidates for spine surgery may experience multiple adverse effects from the prolonged conservative and non-operative management of chronic low back pain. Due to the aging population, there is an increased demand for lumbar spine surgery in the geriatric population. At the time these patients are candidates for surgery, they might encounter the results of the conservative management including disabling pain, catastrophizing, and Kinesiophobia. The chronicity of the spine condition and the associated pain may result in functional disability, poor nutrition, and poor pain management, all of which may result in a multisystemic impact on their overall health in the form of frailty. Prehabilitation has been studied in the past to evaluate its impact on the postoperative outcomes for patients scheduled for abdominal surgery, cardiac surgery, and thoracic surgery. Currently, there are a few trials evaluating the impact of prehabilitation in spine surgery. However, there are limited data on the impact of prehabilitation on frail geriatric patients undergoing spine surgery and whether prehabilitation will impact frail patients' preoperative and postoperative functional recovery and pain management. Based on the current literature, the investigator will hypothesize that prehabilitation will improve frail geriatric patients' preoperative and postoperative functional capacity as assessed by a six-minute walk test and will minimize the incidence of postoperative complications. In addition, the investigator will also hypothesize that prehabilitation in the form of a multimodal approach (physical exercise, nutritional, pain, and neuroscience education) will increase the chances of discharge to home in the postoperative setting, and as a result will lead to a decrease overall healthcare expenditure and total costs. Specific Aims: 1. Does Multimodal Prehabilitation improve frail patients' preoperative functional capacity before spine surgery? 2. Does Multimodal Prehabilitation improve frail patients' postoperative outcomes after spine surgery? 3. Does Multimodal Prehabilitation improve frail patients' postoperative functional capacity after spine surgery? The investigator will hypothesize that Multimodal Prehabilitation (physical, nutritional, and cognitive) improves frailty, functional capacity, and perioperative outcomes after spine surgery. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05034341
Study type Interventional
Source University of Florida
Contact
Status Terminated
Phase N/A
Start date November 1, 2021
Completion date May 8, 2024

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04992286 - Detection, Evaluation and Monitoring of Frailties in the Elderly (FRAGING) N/A
Enrolling by invitation NCT05009706 - Self-care in Older Frail Persons With Heart Failure Intervention N/A
Completed NCT05529147 - The Effects of Medication Induced Blood Pressure Reduction on Cerebral Hemodynamics in Hypertensive Frail Elderly
Recruiting NCT04444544 - Quality of Life and High-Risk Abdominal Cancer Surgery
Completed NCT04061785 - Impact of Skills Acquired Through Judo Training on Risk Factors for Falling in Elderly Men and Women N/A
Completed NCT04140890 - Supporting Habit Formation to Attenuate Prefrailty in Elders: Pilot Study N/A
Recruiting NCT03141866 - Seated Physical Activity in Ageing N/A
Completed NCT04888884 - Loss of Independence - a Rapid Alternative to Frailty Screening in a Swedish ED Setting
Recruiting NCT04145726 - Frailty In Thoracic Surgery for Esophageal Cancer
Recruiting NCT04717869 - Identifying Modifiable PAtient Centered Therapeutics (IMPACT) Frailty
Not yet recruiting NCT06022666 - PATH Program for for Severely Frail or Cognitively Impaired Patients Scheduled for Cancer Surgery. N/A
Not yet recruiting NCT04514536 - Evaluation of a Health Monitoring Platform for Elderly in Home Care Context N/A
Completed NCT01126723 - Effects of Tai Chi on Frailty in Elderly Adults N/A
Completed NCT00183040 - HORMA: Hormonal Regulators of Muscle and Metabolism in Aging Phase 2
Active, not recruiting NCT05961319 - Smart Home Technologies for Assessing and Monitoring Frailty in Older Adults
Enrolling by invitation NCT05047731 - Antihypertensive Deprescribing in Long-term Care N/A
Completed NCT04956705 - Vitamin D and Calcium Supplementation at Danish Nursing Homes N/A
Recruiting NCT03824106 - Frailty Rehabilitation Phase 4
Recruiting NCT04518423 - Prevalence, Determinants and Natural History of Frailty and Pre-frailty in Elderly People
Completed NCT04087343 - Strength on Wheels: A Meal Delivery and Exercise Intervention for Homebound Older Adults N/A