Spinal DeformityNCT05452057
Prehab for Adult Spinal Deformity Surgery
A study testing Prehabilitation in people with Spinal Deformity, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Prehabilitation is defined as the process of enhancing patients' functional capacity and overall fitness to enable them to withstand a forthcoming stressor (e.g. surgery). Although there are different models of prehabilitation, multimodal prehabilitation is recommended to address the physical and psychological health… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Spinal Deformity
- What is being tested?
- Prehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteCanada
- Study dates
- 3 Nov 2022to 17 Oct 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Candidates for spinal deformity surgery;
- recruited at least 12 weeks preoperatively;
- a frailty score of 0.27 or greater as indicated by the Modified Frailty index-11; and
- proficient in English to comprehend informed consent and intervention instructions
Who cannot join
- Refusal to be randomized;
- have significant comorbidity precluding participation in prehabilitation exercises (including Canadian Cardiovascular Society class III/IV coronary disease; New York Heart Association class III/IV congestive heart failure; neurological or musculoskeletal disorder prohibiting exercise; major neuropsychiatric disorder)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prehabilitation for Adult Spinal Deformity Surgery: a Feasibility Randomized Controlled Trial
Prehabilitation is defined as the process of enhancing patients' functional capacity and overall fitness to enable them to withstand a forthcoming stressor (e.g. surgery). Although there are different models of prehabilitation, multimodal prehabilitation is recommended to address the physical and psychological health outcomes prior to surgery. Multimodal prehabilitation commonly consists of exercise-training, nutritional, and psychological support. Evidence suggests that prehabilitation improves preoperative physical fitness and reduces postoperative complications and length of stay in patients undergoing major abdominal surgery. However, the evidence for the feasibility and effects in spinal deformity surgery are less understood. This study is a two arm, pilot randomized controlled trial to assess the feasibility of a multimodal prehabilitation program prior to surgery for spinal deformity in adults. Participant outcomes will be measured using standardized fitness testing, self-report questionnaires, and medical record reviews at baseline, one week preoperatively, and at 30 days postoperatively.
Read the detailed description
Spinal deformity is defined as a curvature in the spine where the alignment is outside of defined normal limits in the sagittal (e.g., kyphosis, lordosis), or coronal plane (e.g., scoliosis). The severity of symptoms among patients with spinal deformity varies and is contingent upon the type and extent of deformity. Studies have shown that adult patients with symptomatic spinal deformity have similar or worse patient-reported health-related quality of life (HRQOL) compared with other pathological conditions such as arthritis, chronic pulmonary disease, congestive heart failure, diabetes, and cancer. Over the last decade, multiple studies have demonstrated a significant improvement in patient HRQOL, disability and leg pain following spinal deformity surgery at 2-years of follow up. In contrast, patients who are treated non-surgically do not exhibit significant HRQOL changes compared to baseline. Spinal deformity surgery, however, can be associated with complications, with rates as high as 77%. Possible complications include hemorrhage, cerebrospinal fluid leak, screw malposition, ischemic optic neuropathy, thromboembolic events, cardiopulmonary complications, and infection. Recovery from surgery is long-term and challenging, with an expectation that patients may feel worse for up to 3 months after surgery. Moreover, length of hospital stay (LOS), discharge to inpatient rehabilitation, and additional post-discharge, home-care support following spinal deformity surgery are significant drivers of health care costs. In fact, LOS has been reported up to 100 days, with predictors of increased LOS including frailty and functional status. Thus, strategies that can improve preoperative functional status, and subsequently reduce postoperative LOS and improve postoperative recovery trajectories are important for adults undergoing surgery for spinal deformity.
- Conditions
- Spinal Deformity
- Being tested
- Prehabilitation
- Keywords
- Prehabilitation, Exercise, Stress management, Nutrition
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrehabilitationBehavioural
A Registered Kinesiologist will provide your exercise prescription during your first visit for the study. Your exercise sessions will consist of moderate-intensity cardiovascular (or aerobic) exercise, like brisk walking, for 30 minutes. You will also perform resistance exercises (weight lifting) for 30 minutes that will help strengthen your muscles with a focus on muscles that may be affected by your surgery. To complete your exercises, you will receive resistance bands, exercise ball, and exercise manual.
You will also meet with a Registered Dietician within a week of consent to receive information on healthy eating and you will receive protein to improve your nutritional health.
A consult with an expert in psychology to discuss ways to reduce your stress within a week of consent. Some strategies to help reduce your stress may include breathing exercises, being mindful, or other relaxation methods.
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation | Experimental | This will include an individualized, light to moderate intensity resistance training and aerobic exercise components. Each prescribed session will include: a minute warm-up, aerobic exercise, resistance training, and a cool-down, but may be modified to accommodate the participants exercise ability.
A registered dietitian will provide an individualized nutrition assessment and counselling session within the first week of prehabilitation and again in the week prior to surgery.
A staff psychologist or psychology resident will deliver a ~60-minute psychoeducation session that focuses on stress management via relaxation, mindfulness, goal setting, and strategies to overcoming barriers to practice. In the week prior to surgery, participants will be offered a second consultation with the psychology team member to review their stress management experiences and provide further support for the acute perioperative period. Receives: Behavioral: Prehabilitation |
| Usual care | No intervention | Usual care group will be asked to resume your typical lifestyle behaviours until the date of the surgery and will be provided with publicly available resources on physical activity, diet, and stress management. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility assessment: Recruitment and Enrollment
- Recruitment success will be measured by the proportion of participants who are randomized divided by the number of identified eligible patients. Reasons for non-participation will be collected. The feasibility target is 25%.
Measured: 6 months
Feasibility assessment: Intervention fidelity
- Reasons for, all or part, the intervention not being delivered as intended will be recorded. The kinesiologist will communicate with prehabilitation participants via telephone and/or email weekly to ensure program compliance, record adherence, support appropriate progression, and to address any barriers to exercise that may prevent participation.
Measured: pre-operative
Feasibility assessment: Adherence,
- Adherence to stress management and utilization of smoking cessation tools (as required) will be recorded weekly using a logbook within the participant manuals. This includes the attendance to consultations with RD and psychologist, number of relaxation sessions per week; compliance with RD recommendations for dietary behaviours, protein supplementation, and for smokers, the tools used, and the number of times accessed.
Measured: pre-operative
Feasibility assessment: Retention
- The frequency of drop-out during program participation will be documented including reasons for drop-out. The feasibility target for attrition is less than 15%.
Measured: 6 months
Feasibility assessment: Safety and adverse events
- Any safety or adverse events related to the prehabilitation intervention will be reported during weekly telephone calls with participants. Reporting and grading will follow the Common Terminology Criteria for Adverse Events version 5.0.
Measured: 6 months
Feasibility assessment: Cost.
- Cost of delivery for the prehabilitation intervention will be captured based on the individual perspective. This will be calculated based on the quantity of resources consumed, the unit cost of those resources related to the intervention, and personnel cost for delivery of the intervention.
Measured: 6 months
Secondary outcomes (3)
Clinical outcomes: hospital length of stay
- Postoperative LOS will be recorded from the participant medical record in days from the time of surgery until hospital discharge.
Measured: Post-operative
Clinical outcomes: Discharge disposition
Discharge destination (i.e. rehabilitation) and total inpatient stay (if applicable) will recorded in days.
Measured: Post-operative
Clinical outcomes: Complications
Complications, including mortality, will follow the Clavien-Dindo classification. Any health event that requires readmission will also be documented. This will be recorded during hospitalization and within 6 months postoperatively.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start3 Nov 2022
- Primary completion17 Oct 2024
- Study completion17 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal DeformityStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized (1:1)
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Santa Mina, University Health Network, Toronto
- Investigators
- Daniel Santa Mina, PhD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05452057
- Sponsor's protocol ID
- 21-5303
- Status last verified
- Mar 2026
- First submitted
- 30 Jun 2022
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prehabilitation for Adult Spinal Deformity Surgery: a Feasibility Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05452057
- Acronym / sponsor ID
- 21-5303
- Conditions
- Spinal Deformity
- Keywords
- Prehabilitation, Exercise, Stress management, Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 3 Nov 2022 (actual)
- Primary completion
- 17 Oct 2024 (actual)
- Study completion
- 17 Oct 2024 (actual)
- First posted
- 11 Jul 2022 (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.
Prehabilitation is defined as the process of enhancing patients' functional capacity and overall fitness to enable them to withstand a forthcoming stressor (e.g. surgery). Although there are different models of prehabilitation, multimodal prehabilitation is recommended to address the physical and psychological health outcomes prior to surgery. Multimodal prehabilitation commonly consists of exercise-training, nutritional, and psychological support. Evidence suggests that prehabilitation improves preoperative physical fitness and reduces postoperative complications and length of stay in patients undergoing major abdominal surgery. However, the evidence for the feasibility and effects in spinal deformity surgery are less understood. This study is a two arm, pilot randomized controlled trial to assess the feasibility of a multimodal prehabilitation program prior to surgery for spinal deformity in adults. Participant outcomes will be measured using standardized fitness testing, self-report questionnaires, and medical record reviews at baseline, one week preoperatively, and at 30 days postoperatively.
Detailed description
Spinal deformity is defined as a curvature in the spine where the alignment is outside of defined normal limits in the sagittal (e.g., kyphosis, lordosis), or coronal plane (e.g., scoliosis). The severity of symptoms among patients with spinal deformity varies and is contingent upon the type and extent of deformity. Studies have shown that adult patients with symptomatic spinal deformity have similar or worse patient-reported health-related quality of life (HRQOL) compared with other pathological conditions such as arthritis, chronic pulmonary disease, congestive heart failure, diabetes, and cancer. Over the last decade, multiple studies have demonstrated a significant improvement in patient HRQOL, disability and leg pain following spinal deformity surgery at 2-years of follow up. In contrast, patients who are treated non-surgically do not exhibit significant HRQOL changes compared to baseline. Spinal deformity surgery, however, can be associated with complications, with rates as high as 77%. Possible complications include hemorrhage, cerebrospinal fluid leak, screw malposition, ischemic optic neuropathy, thromboembolic events, cardiopulmonary complications, and infection. Recovery from surgery is long-term and challenging, with an expectation that patients may feel worse for up to 3 months after surgery. Moreover, length of hospital stay (LOS), discharge to inpatient rehabilitation, and additional post-discharge, home-care support following spinal deformity surgery are significant drivers of health care costs. In fact, LOS has been reported up to 100 days, with predictors of increased LOS including frailty and functional status. Thus, strategies that can improve preoperative functional status, and subsequently reduce postoperative LOS and improve postoperative recovery trajectories are important for adults undergoing surgery for spinal deformity.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized (1:1)
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation | Experimental | Behavioral: PrehabilitationThis will include an individualized, light to moderate intensity resistance training and aerobic exercise components. Each prescribed session will include: a minute warm-up, aerobic exercise, resistance training, and a cool-down, but may be modified to accommodate the participants exercise ability. A registered dietitian will provide an individualized nutrition assessment and counselling session within the first week of prehabilitation and again in the week prior to surgery. A staff psychologist or psychology resident will deliver a ~60-minute psychoeducation session that focuses on stress management via relaxation, mindfulness, goal setting, and strategies to overcoming barriers to practice. In the week prior to surgery, participants will be offered a second consultation with the psychology team member to review their stress management experiences and provide further support for the acute perioperative period. |
| Usual care | No intervention | –Usual care group will be asked to resume your typical lifestyle behaviours until the date of the surgery and will be provided with publicly available resources on physical activity, diet, and stress management. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Candidates for spinal deformity surgery;
- recruited at least 12 weeks preoperatively;
- a frailty score of 0.27 or greater as indicated by the Modified Frailty index-11; and
- proficient in English to comprehend informed consent and intervention instructions
Key exclusion criteria (2 listed)
- Refusal to be randomized;
- have significant comorbidity precluding participation in prehabilitation exercises (including Canadian Cardiovascular Society class III/IV coronary disease; New York Heart Association class III/IV congestive heart failure; neurological or musculoskeletal disorder prohibiting exercise; major neuropsychiatric disorder)
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 |
|---|---|---|
| PrehabilitationA Registered Kinesiologist will provide your exercise prescription during your first visit for the study. Your exercise sessions will consist of moderate-intensity cardiovascular (or aerobic) exercise, like brisk walking, for 30 minutes. You will also perform resistance exercises (weight lifting) for 30 minutes that will help strengthen your muscles with a focus on muscles that may be affected by your surgery. To complete your exercises, you will receive resistance bands, exercise ball, and exercise manual. You will also meet with a Registered Dietician within a week of consent to receive information on healthy eating and you will receive protein to improve your nutritional health. A consult with an expert in psychology to discuss ways to reduce your stress within a week of consent. Some strategies to help reduce your stress may include breathing exercises, being mindful, or other relaxation methods. | Behavioural | Prehabilitation |
Primary outcome
Feasibility assessment: Recruitment and Enrollment
Time frame: 6 months
- Recruitment success will be measured by the proportion of participants who are randomized divided by the number of identified eligible patients. Reasons for non-participation will be collected. The feasibility target is 25%.
Feasibility assessment: Intervention fidelity
Time frame: pre-operative
- Reasons for, all or part, the intervention not being delivered as intended will be recorded. The kinesiologist will communicate with prehabilitation participants via telephone and/or email weekly to ensure program compliance, record adherence, support appropriate progression, and to address any barriers to exercise that may prevent participation.
Feasibility assessment: Adherence,
Time frame: pre-operative
- Adherence to stress management and utilization of smoking cessation tools (as required) will be recorded weekly using a logbook within the participant manuals. This includes the attendance to consultations with RD and psychologist, number of relaxation sessions per week; compliance with RD recommendations for dietary behaviours, protein supplementation, and for smokers, the tools used, and the number of times accessed.
Feasibility assessment: Retention
Time frame: 6 months
- The frequency of drop-out during program participation will be documented including reasons for drop-out. The feasibility target for attrition is less than 15%.
Feasibility assessment: Safety and adverse events
Time frame: 6 months
- Any safety or adverse events related to the prehabilitation intervention will be reported during weekly telephone calls with participants. Reporting and grading will follow the Common Terminology Criteria for Adverse Events version 5.0.
Feasibility assessment: Cost.
Time frame: 6 months
- Cost of delivery for the prehabilitation intervention will be captured based on the individual perspective. This will be calculated based on the quantity of resources consumed, the unit cost of those resources related to the intervention, and personnel cost for delivery of the intervention.
3 secondary outcomes
Clinical outcomes: hospital length of stay
Time frame: Post-operative
Clinical outcomes: Discharge disposition
Time frame: Post-operative
Clinical outcomes: Complications
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
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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.
Daniel Santa Mina, PhD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prehabilitation in people with Spinal Deformity, run by University Health Network, Toronto at 1 site in Canada.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 12 Mar 2026. 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 Canada. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Feasibility assessment: Recruitment and Enrollment (time frame: 6 months). The study lists 6 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 12 Mar 2026.