Lumbar Spine InjuryNCT05034341
Does Prehabilitation Improve Outcomes in Patients Undergoing Complex Spine Fusion Surgery?
A study testing Multimodal Prehabilitation and Standard Pre-Surgical Clinical Care in people with Lumbar Spine Injury and Spinal Fusion, run by University of Florida at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Lumbar Spine Injury, Spinal Fusion, Frailty
- What is being tested?
- Multimodal Prehabilitation and Standard Pre-Surgical Clinical Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2021to 8 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Frailty score of 3 or more (based on Johns Hopkins Frailty Assessment).
- Age 55 and older
- Elective Lumbar or thoracolumbar Spine Fusion Surgery
Who cannot join
- Emergency surgery
- Time-sensitive surgery
- Spine trauma, tumor, or infection
- Physical condition that limits exercise: Lower extremity amputation, hemiplegia or hemiparesis, stroke with residual weakness, symptomatic severe cardiac disease (for example: severe aortic stenosis, unstable angina)
- Patient refusal
- Severe cognitive dysfunction preventing participation or consenting.
Trial locations and contacts
1 site in 1 country.
United States1 site
UF Health of University of Florida
Gainesville, Florida, 32610
About this study
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.
Read the detailed 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:
- Does Multimodal Prehabilitation improve frail patients' preoperative functional capacity before spine surgery?
- Does Multimodal Prehabilitation improve frail patients' postoperative outcomes after spine surgery?
- 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.
- Conditions
- Lumbar Spine Injury, Spinal Fusion, Frailty, Prehabilitation, Nutritional Supplementation, Functional Outcome
- Being tested
- Multimodal Prehabilitation, Standard Pre-Surgical Clinical Care
- Keywords
- Frailty, Prehabilitation, Perioperative Outcomes
- Medical subject headings
- Spinal Injuries, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal PrehabilitationOther
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.
Standard Pre-Surgical Clinical CareOther
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Multimodal Prehabilitation Arm | Experimental | 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. Receives: Other: Multimodal Prehabilitation |
| Standard Clinical Care Comparison Arm | Active comparator | 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 Receives: Other: Standard Pre-Surgical Clinical Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frailty Assessment
Johns Hopkins Frailty Assessment
Measured: 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
Measured: Baseline up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start1 Nov 2021
- Primary completion8 May 2024
- Study completion8 May 2024
Why it stopped: PI leaving institution and unable to complete study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spine InjuryStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Basma Mohamed, M.D., Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05034341
- Sponsor's protocol ID
- IRB202000987
- Other IDs
- OCR39834
- Status last verified
- May 2024
- First submitted
- 1 Sep 2021
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Prehabilitation Improve Outcomes in Patients Undergoing Complex Spine Fusion Surgery?
- ClinicalTrials.gov ID
- NCT05034341
- Acronym / sponsor ID
- IRB202000987
- Conditions
- Lumbar Spine Injury, Spinal Fusion, Frailty, Prehabilitation, Nutritional Supplementation, Functional Outcome
- Keywords
- Frailty, Prehabilitation, Perioperative Outcomes
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI leaving institution and unable to complete study.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 8 May 2024 (actual)
- Study completion
- 8 May 2024 (actual)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- Does Multimodal Prehabilitation improve frail patients' preoperative functional capacity before spine surgery?
- Does Multimodal Prehabilitation improve frail patients' postoperative outcomes after spine surgery?
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multimodal Prehabilitation Arm | Experimental | Other: Multimodal PrehabilitationThe 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. |
| Standard Clinical Care Comparison Arm | Active comparator | Other: Standard Pre-Surgical Clinical CareThe 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 |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Frailty score of 3 or more (based on Johns Hopkins Frailty Assessment).
- Age 55 and older
- Elective Lumbar or thoracolumbar Spine Fusion Surgery
Key exclusion criteria (6 listed)
- Emergency surgery
- Time-sensitive surgery
- Spine trauma, tumor, or infection
- Physical condition that limits exercise: Lower extremity amputation, hemiplegia or hemiparesis, stroke with residual weakness, symptomatic severe cardiac disease (for example: severe aortic stenosis, unstable angina)
- Patient refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal PrehabilitationIn 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. | Other | Multimodal Prehabilitation Arm |
| Standard Pre-Surgical Clinical Care* 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. | Other | Standard Clinical Care Comparison Arm |
Primary outcome
Frailty Assessment
Time frame: Baseline up to 3 months
Johns Hopkins Frailty Assessment
6 Minute Walk Test
Time frame: Baseline up to 3 months
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
Results and safety
The study was stopped early (reason given: PI leaving institution and unable to complete study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Basma Mohamed, M.D. principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal Prehabilitation and Standard Pre-Surgical Clinical Care in people with Lumbar Spine Injury and Spinal Fusion, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: PI leaving institution and unable to complete study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frailty Assessment (time frame: Baseline up to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2024.