Improving rehabilitation for older adults after hip or knee surgery through healthy habits
Effectiveness of Healthy Habits for Hospitalized Older Adults to Optimize Rehabilitation
This study tests whether teaching older adults healthy habits like better nutrition and sleep can help them recover faster and more effectively after hip or knee surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 124 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Baylor College of Medicine Academic / other |
| Locations | 3 sites (Galveston, Texas and 2 other locations) |
| Trial ID | NCT04269239 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of behavioral interventions aimed at promoting healthy habits in older adults recovering from hip or knee arthroplasty. Participants will be divided into two groups: one will focus on general healthy habits such as nutrition and physical activity, while the other will concentrate on improving sleep habits. Both groups will receive guidance from a study therapist and undergo physical and cognitive assessments at various stages, including before surgery and at a six-month follow-up. The goal is to enhance rehabilitation outcomes by increasing adherence to post-surgical recommendations.
Who should consider this trial
Good fit: Ideal candidates are adults aged 40 and older who are scheduled for hip or knee arthroplasty and have insomnia.
Not a fit: Patients with severe mental health disorders or untreated comorbid sleep disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve recovery and functional health in older adults after orthopedic surgery.
How similar studies have performed: Other studies have shown promising results with behavioral interventions in rehabilitation, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with a minimum age of 40 years, no maximum age limit, planning on having a hip or knee arthroplasty. 2. The ability to communicate during the screening process (e.g., no aphasia or other severe language impairment). 3. Meet DSM-5 criteria for insomnia disorder assessed by Duke Structured Interview for Sleep Disorders. 4. Score ≥8 on the Insomnia Severity Index (ISI) or ≥5 on the Pittsburgh Sleep Quality Index (PSQI). 5. Referral and attendance of medical rehabilitation post-discharge. Exclusion Criteria: 1. Evidence of recent severe mental health disorders (e.g., suicide attempt or psychiatric hospitalization in the past year). 2. Presence of psychotic disorder, substance abuse or dependence, or bipolar disorder assessed by MINI International Neuropsychiatric Inventory (to increase generalizability other psychiatric comorbidities such as depression or anxiety will not be excluded). 3. Untreated comorbid sleep disorders based on structured diagnostic interview including: narcolepsy, periodic leg movement disorder, and/or obstructive sleep apnea risk. 4. Cognitive impairment defined as \<20 on the Mini Mental Status Exam (MMSE) that could potentially limit comprehension of the intervention. Note, while an MMSE of \<24 is often used as a cutoff for cognitive impairment, we do not wish to exclude those with mild cognitive problems from this study as there is evidence that individuals with mild cognitive problems still benefit from insomnia treatments.
Where this trial is running
Galveston, Texas and 2 other locations
- University of Texas Medical Branch — Galveston, Texas, United States (Recruiting)
- Baylor College of Medicine Medical Center — Houston, Texas, United States (Recruiting)
- Kelsey Seybold Clinic — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Sara Nowakowski, PhD — Baylor College of Medicine
- Study coordinator: Doris Escobedo
- Email: doris.escobedo@bcm.edu
- Phone: 713-487-5540
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.