UCHealth Steadman Hawkins Clinic Denver
Englewood, Colorado, 80012, United States
Location status: Recruiting
NCT Number: NCT05165927
The investigators plan to investigate the efficacy of blood flow restriction (BFR) therapy in post operative rehabilitation following hip arthroscopy. BFR has shown to be great at helping the recovery process. SAGA is a well-known smart training technology company, and the investigators aim to partner with SAGA to use the BFR cuffs as the intervention method. The BFR cuff will be added to the current SOC for hip scope PT for the intervention group.
Interested in participating?
Request Info18 year–60 year
All sexes
Interventional
Not applicable
Englewood, Colorado, 80012, United States
Location status: Recruiting
Study Design and Research Methods i. Timeline: Treatment Protocol duration 12 weeks per participant beginning post operative day 1 following hip arthroscopy. PRO's will be collected out to 2 years post-surgery and standard rehabilitation will follow the 12-week intervention period for both the control and experimental group. Study will be a 2-year timeline in total.
ii. Procedures: Patients will be randomized to control group, who will undergo Steadman Hawkins Clinic Denver's standard hip arthroscopy rehab protocol (see appendix) or to the intervention group, who will undergo standard rehab protocol with addition of BFR. Subjects will be randomized 1:1 for intervention vs. control and controlled for gender assigned at birth.
iii. Frequency of BFR Training: 6 days per week phase 1, 3 days per week phases 2 and 3 iv. Frequency of clinic visits PT: 1 day per week v. Intervention Group: The following exercises outlined are the specific exercises that will be performed in addition to SOC. Only these exercises will involve the use of the BFR cuff.
i. Week 1: quadriceps set, gluteal set, hamstring set ii. Week 2: short arc quad, hook lying adduction/internal rotation isometric, hook lying abduction/external rotation isometric iii. Week 3: long arc quad, bridge, standing hamstring curl
i. Week 4: mini squat, prone hip extension over plinth, quadruped rock ii. Week 5: mid-range squat, modified single leg bridge foot on ball, heel slide strap assist iii. Week 6: step up, standing hip abduction, single leg bridge
a. Dosage: 80% LOP at 20-30% 1 RM.1 RM re-evaluated every 2 weeks to adjust resistance prescription. 30x15x15x15 repetitions with 30 sec rests between sets. At least 1 min rest between exercises with occlusion OFF b. Frequency: All 3 resistive exercises performed at least 3 days per week. The first of these sessions will be performed in clinic supervised by PT to assess LOP and form prior to performance at home c. Exercises: i. Weeks 6-12: Single leg squat to 45 deg knee flexion (holding weight as tolerated), single leg Romanian dead lift (holding weight a weight as tolerated), Bulgarian split squat (holding a weight as tolerated)
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
BFR cuffs will be used at home during specified exercises in addition to SOC for post hip scope PT.
Time frame: 2 Years
Time frame: 2 Years
Time frame: 2 Years
Time frame: 2 Years
Range 0 (poor health) - 100 (good health); MCD = Δ13
Time frame: 2 Years
Range 0 (extreme difficulty) - 100 (extreme difficulty); MDIC = Δ 123
Time frame: 2 Years
PROMIS Pain: Range 0 (low pain) - 100 (high pain); MDC = Δ 85.
Time frame: 2 Years
Range 1 (low resilience) - 5 (high resilience)
Time frame: 2 Years
PROMIS Physical Function: Range 0 (low function) - 100 (high function); MDC = Δ 85
Time frame: 2 Years
MDC = Δ low (1-2.99) to normal (3-4.3) to high (4.31-5)
Time frame: 2 Years
Range 0 (disability because of knee problems) - 10 (national or international level soccer)
Contact information is provided by the study sponsor or research team.
University of Colorado, Denver
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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