Recruiting

Observational Study

Sponsor:

Yale University

Code:

NCT06407427

Conditions

Spine Degeneration

Hip Arthritis

Knee Osteoarthritis

Hip Fractures

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

App for in-bed conditioning exercises

Usual care

Study Details

Brief summary:

This study aims to evaluate the effectiveness of a mobile application in improving postoperative rehabilitation outcomes among patients undergoing orthopedic surgery.

Conditions

Spine Degeneration

Hip Arthritis

Knee Osteoarthritis

Hip Fractures

Study ID

NCT06407427

Start date

Jul 21, 2025

Status verified date

Aug, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • English reading/speaking
  • Are status post low-energy hip fracture, total knee/hip arthroplasty, or single to multilevel spinal fusion without paralysis
  • Must be able bodied enough to participate in a mobile app tool for physical therapy
  • Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration\]

Exclusion Criteria:

  • Severe cognitive impairment: Not alert and oriented to person, place, time, and reason for being the hospital; and unable to follow 2 step commands
  • Severe physical impairment:

  • Neurologic paralysis
  • Polytraumas with restrictions incompatible with anti-gravity exercises
  • Knee immobilization, bed rest
  • Unstable medical conditions:

  • On ventilatory support
  • Utilizing high degrees of oxygen support (continuous BiPAP, high flow nasal cannula, nonrebreather mask, aerosol mask >3L/min)
  • Hemodynamic instability requiring pressor medication support (can include those on pressors for elevated mean arterial pressure goals (MAPs))
  • Neurologically instable with strokes, hemorrhages, increased intracranial pressures
  • Open wounds or surgical incisions

  • Tenuous closed wounds requiring immobilization or bending restrictions
  • Open wounds that are either packed/dressed or dressed with a wound vacuum
  • Surgical wounds that are draining fluid or purulence
  • Vulnerable populations

  • Incarcerated individuals
  • Patients without access to a mobile phone with iOS capability

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Enhanced Care

Post-operative usual care where patients will receive standard care plus the use of a tool.

active comparator: Usual Care

Post-operative usual care where patients will receive standard care alone.

Interventions

App for in-bed conditioning exercises

Participants will use an application (app) in facilitating in-bed conditioning exercises for hospitalized patients

Usual care

All participants will receive usual care in the post-operative setting.

Primary outcome measure

  • Change in patient performance during physical therapy (PT) [ Time Frame: Initial (postoperative day 1) and Final PT Visit (at discharge approximately day 3-5 postoperative) ]

Central Contacts and Locations

Central contacts

Rajiv S Vasudevan, M.D.

650-714-7908Rajiv.vasudevan@yale.edu

David Gargano, PA-C

475-414-4317david.gargano@yale.edu

Locations

Yale New Haven Hospital Saint Raphael's Campus

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Rajiv S Vasudevan, M.D.

650-714-7908Rajiv.vasudevan@yale.edu

David Gargano, PA-C

475-414-4317david.gargano@yale.edu

Principal Investigator:

Rajiv S Vasudevan, M.D.

More Information

Sponsor

Yale University

Last update posted

Aug 5, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Yale University on 2026-08-05.