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Effect of Leg Strengthening Exercise After Hip Fracture

This study has been completed.
Sponsor:
Information provided by:
Arcadia University
ClinicalTrials.gov Identifier:
NCT00997776
First received: October 18, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Hip Fractures
 Other: progressive resistance exercise
Other: TENS
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Leg Strengthening Exercise After Hip Fracture

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Arcadia University:

Primary Outcome Measures:
  • lower extremity force production [ Time Frame: one year after hip fracture ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • six minute walk distance [ Time Frame: one year post fracture ] [ Designated as safety issue: No ]
  • free and fast gait speed [ Time Frame: one year post fracture ] [ Designated as safety issue: No ]
  • modified physical performance test [ Time Frame: one year post fracture ] [ Designated as safety issue: No ]
  • SF-36 physical function [ Time Frame: one year post fracture ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: August 2002
Study Completion Date: June 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise
High intensity lower extremity exercise
 Other: progressive resistance exercise
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.
Other Name: strengthening exercise
Sham Comparator: Attention control
lower extremity TENS
 Other: TENS
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.
Other Name: TENS

Detailed Description:

Poor functional outcomes are reported for the majority of older adults who sustain a hip fracture. The ability of hip fracture patients to make sustained functional improvements above and beyond natural recovery is unknown. It has been shown that gym-based programs can help old adults regain function after hip fracture. It is unclear if these results could be translated into the home setting that lacks the gym-based equipment, or if improvement would be sustainable. This program compares high intensity strength training performed in the home twice weekly for 10 weeks to an attention placebo control in which participants receive sensory electrical stimulation to leg muscles.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00997776

Locations
United States, Pennsylvania
Arcadia University
Glenside, Pennsylvania, United States, 19038
Sponsors and Collaborators
Arcadia University
Investigators
Principal Investigator: Kathleen K Mangione, PT, PhD Arcadia University
  More Information

No publications provided

Responsible Party: Kathleen Kline Mangione, Professor, Arcadia University
ClinicalTrials.gov Identifier: NCT00997776     History of Changes
Other Study ID Numbers: MANGIONE-LEG STRENGTH 2006, 1 R03 HD041944-01A1
Study First Received: October 18, 2009
Last Updated: October 18, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Arcadia University:
Hip Fracture
Exercise
Rehabilitation
Functional Performance

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Wounds and Injuries
 Femoral Fractures
Hip Injuries
Leg Injuries

ClinicalTrials.gov processed this record on May 19, 2013