An interventional study of Multimodal Prehabilitation and Standard Pre-Surgical Clinical Care in Lumbar Spine Injury, Spinal Fusion and Frailty, sponsored by University of Florida. Terminated at 1 site in United States. Open to participants aged 55 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-05-13.
Sponsored by University of Florida · Not applicable, Interventional, and Treatment
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.
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:
The investigator will hypothesize that Multimodal Prehabilitation (physical, nutritional, and cognitive) improves frailty, functional capacity, and perioperative outcomes after spine surgery.
57 studies on the registry are indexed under Spinal Injuries; 15 are open to participants now.
This study's enrollment of 10 is below the median of 52 across 31 interventional studies indexed under Spinal Injuries.
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Of its 180 completed or terminated interventional studies of FDA-regulated products, 143 (79%) have results posted.
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Exclusion Criteria:
The Multimodal Prehabilitation group will receive: * An exercise program focusing on aerobic exercise as well as strength training. Sessions will be supervised by a physical therapist, 2 times a week for a minimum of 6-8 weeks in addition to a home exercise program. Patients' compliance will be monitored by phone each week. * Protein supplements in the form of protein shakes at a dose of 1.2-1.5 gram per kg daily for 6-8 weeks. Protein supplements will be calculated based on ideal body weight and will be given to the patient with instructions on specific use. Diabetic patients will receive protein supplements that are sugar-free. * Pain and Neuroscience Education: Per University of Florida Health Pain and Neuroscience program at Shands hospital. * Standard Clinical Care: Preoperative medical optimization and management, referral to medical specialties as deemed necessary with a focus on preoperative cognitive assessment.
Other: Multimodal Prehabilitation
The Standard Clinical Care Comparison group will receive: * Education related to preoperative activity and home based exercise program. * Standard preoperative consultation with anesthesiology: Preoperative medical optimization and management, referral to medical specialties as deemed necessary with focus on preoperative cognitive assessment. * A final preoperative visit before surgery where a second set of functional assessment will be implemented
Other: Standard Pre-Surgical Clinical Care
In addition to Standard Clinical Care Behavioral - An exercise program focusing on aerobic exercise as well as strength training. Sessions will be supervised by a physical therapist, 2 times a week for a minimum of 6-8 weeks in addition to home exercise program. They will also participate in a single session of Cognitive-Behavioral Therapy and will receive an educational pamphlet about Pain and Neuroscience Education. Dietary Supplement - Protein supplements in the form of protein shakes at a dose of 1.2-1.5 gram per kg daily for 6-8 weeks. Protein supplements will be calculated based on ideal body weight and will be given to the patient with instructions on specific use. Diabetic patients will receive protein supplements that are sugar free.
* Education related to preoperative activity and home-based exercise program. * Standard preoperative consultation with anesthesiology: Preoperative medical optimization and management, referral to medical specialties as deemed necessary with focus on preoperative cognitive assessment.
Frailty Assessment
Johns Hopkins Frailty Assessment
Time frame: Baseline up to 3 months
6 Minute Walk Test
Distance and Percent Predicted Distance Travelled by Walking for 6 Minutes and then evaluating their performance in comparison to normal population. Also, measuring the the symptoms of fatigue and severity of dyspnea on exertion
Time frame: Baseline up to 3 months
Ran from Nov 2021 to primary completion in May 2024, 30 months.
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This study is terminated, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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