NCT04809714

The Role of Blood Flow Restriction Therapy in Postoperative Elderly Patients With Hip Fracture

The Role of Blood Flow Restriction Therapy in the Postop Rehabilitation of Elderly Patients With Hip Fractures: A Randomized Controlled Pilot Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

The investigators aim to study the use of blood flow restriction therapy (BFR) to augment routine post-operative physical therapy in elderly patients (age \>= 65) after recovering from surgical treatment of hip fractures.

Detailed description

For elderly patients, a hip fracture is a life-altering event associated with poor overall outcomes despite early surgical treatment. The elderly population and those with significant osteopenia is growing exponentially and thus the optimal treatment and rehabilitation of hip fractures warrants increased investigation. Despite numerous interventions, falls plague the elderly population and hip fractures remain a very common problem for this population that needs to be addressed. Rapid deconditioning plays a significant role in patient morbidity following hip surgery. Recently, blood flow restriction (BFR) treatment has been shown to be effective in improving muscle strength when combined with low load resistance training physical therapy programs in elderly patients. Few studies have examined BFR in post-operative orthopedic trauma patients. The investigators aim to study the use of BFR to augment post-operative physical therapy in elderly patients (age \>= 65) in the first 2-weeks after recovering from surgical treatment of hip fractures. Due to the profound muscle atrophy that occurs in the immediate postoperative period because of immobility and disuse, the investigators hypothesize that BFR may provide an anabolic effect and conserve muscle strength. The investigators hypothesis was inspired by the findings of the Nobel Prize in Physiology 2019 which describes how varying levels of oxygen shape both physiology and pathology. This is a prospective, randomized blinded 2-week study of elderly patients recovering from surgical treatment of hip fractures with two arms: 1) routine post-op physical therapy 2) routine physical therapy + BFR and neuromuscular electrical stimulation (NMES) beginning on postoperative day 1 and occurring 5 days per week for 2 weeks. To optimize safety, the study will be in an inpatient-only setting and supervised by team members certified in the application of BFR. The investigators plan to apply lessons learned to a larger 8-week intervention upon completion of this short-term pilot study. To our knowledge, this is the first study to use BFR in postoperative geriatric patients. Main outcomes will include thigh leg circumference on postoperative day 1 and at the end of week 2, adverse event log for complications, knee extension strength via handheld dynamometry (HHD) at post-op day 1 and week 2, gait speed, functional tests including timed up and go, opioid MME (morphine milligram equivalent) consumption and patient perceived pain and quality of life measures. The investigators anticipate BFR therapy will be tolerated well, improve global patient health and satisfaction, lead to lower extremity muscle hypertrophy, and enhance functional recovery after geriatric hip fracture carrying tremendous potential for extramural funding and scientific advancement.

Conditions

• Hip Fractures
• Muscle Atrophy

Interventions

Type	Name	Description
DEVICE	Blood Flow Restriction with Delfi Tourniquet System Cuff	Postoperative rehabilitation will occur up to twice a day for 5 days a week for 2 weeks using a Delfi tourniquet system blood pressure cuff with a limb occlusion pressure (LOP) of 60-100%. For each physical therapy session, participants will undergo therapy following a standardized protocol of 3-5 difference exercises each with 4 sets total in addition to NMES.
OTHER	Routine Post-operative Physical Therapy	The control group with undergo a post-op therapy protocol that mirrors that of the intervention group except that they will use a Delfi tourniquet system blood pressure cuff with a limb occlusion pressure (LOP) of only 10%. Participants will use a neuromuscular electrical stimulation device operating at a sub-therapeutic level.

Timeline

• Start date: 2022-01-01
• Primary completion: 2026-12-13
• Completion: 2027-12-31
• First posted: 2021-03-22
• Last updated: 2026-01-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study