Effect of Leg Strengthening Exercise After Hip Fracture

NCT00997776 | Completed Phase 1

• 2 other identifiers: MANGIONE-LEG STRENGTH 20061R03HD041944-01A1
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this trial was to examine the effectiveness of a short-term leg strengthening exercise program compared to attention control on improving leg strength, walking speed and endurance, physical performance, and physical function one year after hip fracture.

Conditions

Hip Fractures

Keywords

Hip Fracture; Exercise; Rehabilitation; Functional Performance

Outcome Measures

Primary Outcomes (1)

• lower extremity force production

  one year after hip fracture

Secondary Outcomes (4)

• six minute walk distance

  one year post fracture

• free and fast gait speed

  one year post fracture

• modified physical performance test

  one year post fracture

• SF-36 physical function

  one year post fracture

Study Arms (2)

Exercise

EXPERIMENTAL

High intensity lower extremity exercise

Other: progressive resistance exercise

Attention control

SHAM COMPARATOR

lower extremity TENS

Other: TENS

Interventions

progressive resistance exercise OTHER

lower extremity strengthening: 3 sets of 8 repetitions at the 8 repetition maximum (8RM)for the hip and knee extensors, hip abductors, plantarflexors twice weekly for 10 weeks.

Also known as: strengthening exercise

Exercise

TENS OTHER

Transcutaneous electrical nerve stimulation (TENS) to elicit sensory information (comfortable tingling) for 7 minutes to bilateral muscle groups including the gluteal muscles, quadriceps, and gastroc-soleus muscles. TENS administered twice weekly for 10 weeks.

Attention control

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Successful fixation (partial or total hip replacement or open reduction internal fixation) of a hip fracture within the last 6 months
• Were 65 years of age or older, were living at home prior to the fracture, had a physician referral and were discharged from physical therapy.

You may not qualify if:

• Medical history of unstable angina or uncompensated congestive heart failure, ongoing chemotherapy or renal dialysis, history of stroke with residual hemiplegia, Parkinson disease, absent sensation in the lower extremities due to sensory neuropathy, life expectancy of less than 6 months, and Folstein mental status scores \< 20.

Sponsors & Collaborators

• Arcadia University: lead

Study Sites (1)

Arcadia University

Glenside, Pennsylvania, 19038, United States

Location

MeSH Terms

Conditions

Hip Fractures; Motor Activity

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Kathleen K Mangione, PT, PhD

  Arcadia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 18, 2009
• First Posted: October 19, 2009
• Study Start: August 1, 2002
• Primary Completion: January 1, 2006
• Study Completion: June 1, 2006
• Last Updated: October 19, 2009

Record last verified: 2009-10

Locations

US (1)