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The overall objective of this two-group randomized controlled trial is to gather preliminary evidence on the efficacy and safety of early postoperative exercise for improving disability, pain, and general physical health in patients after anterior cervical discectomy and fusion (ACDF) surgery. Our central hypothesis is that an early home exercise program (HEP) performed within the first six weeks after surgery will decrease disability and pain and improve general health, through increases in physical activity and self-efficacy and reductions in fear of movement. The results of our randomized trial will advance research on postoperative management for patients with cervical spine surgery and provide evidence in line with a value-based healthcare approach for optimizing outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Home Exercise Program | Experimental | The early home exercise program is an exercise-based self-management program for patients immediately after cervical spine surgery. |
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| Usual Care | Other | Usual postoperative care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early Home Exercise Program | Behavioral | The early home exercise program is a 6-week program of home exercises with weekly phone calls to monitor progression and compliance. |
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| Measure | Description | Time Frame |
|---|---|---|
| Neck Disability Index (NDI) | The NDI measures disease-specific disability for cervical spine patients. | Up to 12 months after surgery |
| Numeric Rating Scale (NRS) | The NRS measures levels of neck and arm pain intensity. | Up to 12 months after surgery |
| 12-Item Short Form Health Survey (SF-12) | The SF-12 is a measure of general physical and mental health. | Up to 12 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Movement Accelerometry | Movement accelerometry measures general physical activity level. | Up to 12 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Fusion rate | Fusion rate will be measured using dynamic flexion-extension radiograph. | 6 months after surgery |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristin R Archer, PhD, DPT | Vanderbilt University Medical Center | Principal Investigator |
| Rogelio A Coronado, PT, PhD | Vanderbilt University Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
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| Usual Care | Other | Usual care involves standard postoperative management under the direction of the treating surgeon. |
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