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NCT06136286 · ClinicalTrials.gov registry record · NA
ORIF Distal Radius Blood Flow Restriction Therapy
A NA study of Distal Radius Fractures, sponsored by The Methodist Hospital Research Institute.
- Active
- Registry status
- NA
- Development phase
- 70
- Enrollment target
- 1
- Study location
NCT06136286 is a NA study of Distal Radius Fractures that is active but no longer recruiting, run by The Methodist Hospital Research Institute. The registered enrollment target is 70 participants, below the 179-participant average among 4 other Distal Radius Fractures trials with a reported enrollment target (61% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06136286, a NA study of Distal Radius Fractures, is active but no longer recruiting, sponsored by The Methodist Hospital Research Institute.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 70 participants
- Enrollment target
- 1
- Study location
Study Summary
Patients commonly experience a significant amount of muscular atrophy following open reduction internal fixation (ORIF) surgery of distal radius fractures, associated with an increased risk of re-injury, and an increase in time of recovery. A combination of low intensity resistance exercise and blood flow restriction (BFR) therapy has been shown to elicit responses similar to high intensity resistance exercise with reduced risk. We hypothesize that chronic low intensity resistance exercise combined with BFR will improve muscular strength, reduce skeletal muscle atrophy, and will enhance recovery. Therefore, the specific aims of this study are as follows: 1. Determine if BFR added to standard post-operative rehab will prevent skeletal muscle atrophy and promote skeletal muscle growth during 12-weeks of rehab training compared to traditional rehab alone. The working hypothesis, founded on previous literature, is that combined rehab and BFR will enhance skeletal muscle growth and prevent atrophy to a greater extent than rehab alone. 2. Determine if BFR added to standard post-operative rehab will improve muscular strength following surgery compared to traditional rehab alone. Because strength can be attributed to skeletal muscle mass, the working hypothesis, founded on previous literature, is that combined rehab and BFR will enhance skeletal muscle strength and fatigue resistance to a greater extent than rehab alone. 3. Determine if BFR added to standard post-operative rehab will improve functional outcomes following surgery compared to traditional rehab alone. The working hypothesis, founded on previous literature is that BFR will improve functional outcomes over rehab alone.
Conditions Studied
Interventions
- DEVICE Blood Flow Restriction (BFR) Cuff
Study Locations (1)
Texas
- Houston Methodist Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2019-10-22 |
| Est. Completion | 2027-01-01 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06136286
The ClinicalTrials.gov registry entry for NCT06136286 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 179-participant average among 4 other Distal Radius Fractures trials with a reported enrollment target (61% lower). The listed sponsor is The Methodist Hospital Research Institute, which has 126 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Distal Radius Fractures appearing as the primary indexed condition, and to 1 intervention - of which Blood Flow Restriction (BFR) Cuff is the first listed.
NCT06136286 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT06136286 about?
NCT06136286 is a clinical study titled "ORIF Distal Radius Blood Flow Restriction Therapy". Patients commonly experience a significant amount of muscular atrophy following open reduction internal fixation (ORIF) surgery of distal radius fractures, associated with an increased risk of re-injury, and an increase in time of recovery. A combination of low intensity resistance exercise and bloo...
What is the current status of trial NCT06136286?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 70 participants. The study started on 2019-10-22. Estimated completion is 2027-01-01.
What conditions does trial NCT06136286 study?
This clinical trial studies the following conditions: Distal Radius Fractures.
What interventions are being tested in trial NCT06136286?
The interventions under investigation include: Blood Flow Restriction (BFR) Cuff (DEVICE).
Who is sponsoring clinical trial NCT06136286?
This trial is sponsored by The Methodist Hospital Research Institute, which has 126 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06136286 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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