NCT02635308

Brief Summary

This study evaluates the feasibility of implementing a unilaterally biased high-intensity resistance training to facilitate restorative vs. compensatory recovery after "usual care" physical therapy among older adults who have recently incurred a hip fracture. Additionally, physical performance during a sit-to-stand task, muscle function (strength/power), physical function measures, muscle composition, and muscle quality (force/unit area), are assessed before and after targeted high-intensity resistance training.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2013

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2015

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 18, 2015

Completed
Last Updated

December 18, 2015

Status Verified

December 1, 2015

Enrollment Period

2.3 years

First QC Date

November 30, 2015

Last Update Submit

December 15, 2015

Conditions

Keywords

hip fracturephysical functionmuscle functionsymmetry

Outcome Measures

Primary Outcomes (2)

  • muscle strength

    Knee extension muscle strength was measured on an isokinetic dynamometer as a maximum voluntary isometric contraction in newtons (N) of force. The average of three trials was used.

    12 week

  • muscle power

    Leg extension muscle power was measured on a Nottingham power rig in watts (W). The average of three trials was used.

    12 week

Secondary Outcomes (11)

  • sit-to-stand task performance

    12 week

  • usual gait speed

    12 week

  • muscle mass

    12 week

  • Modified Physical Performance Test

    12 week

  • Berg Balance Scale

    12 week

  • +6 more secondary outcomes

Other Outcomes (1)

  • muscle quality

    12 week

Study Arms (1)

Experimental

EXPERIMENTAL

High-Intensity, Unilaterally-Biased Resistance training 3x/wk x 12wk "MOVE"

Behavioral: Unilaterally Biased Resistance Training / "MOVE"

Interventions

High-intensity resistance training including: whole body movement patterns, unilaterally biased lower extremity strength training, task-oriented balance tasks

Also known as: High-Intensity Task Oriented Strength Training / "HI-TOSS"
Experimental

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age greater than 50 yrs
  • Ability to sign informed consent
  • Mental Status MoCA score greater than 22
  • Independent community ambulatory prior to hip fracture
  • Ability to ambulate greater than 50 feet with or without assistive device

You may not qualify if:

  • Previous hip fracture
  • Bilateral hip fracture
  • Pathological fracture
  • Expected life Expectancy less than one year
  • Permanently institutionalized
  • Fracture result of multi-trauma
  • Cardiac abnormalities
  • Neuromuscular impairments
  • Unstable medical conditions
  • Elevated systolic greater than 150 or diastolic blood pressure greater than 100
  • Implanted electronic devices
  • History of stroke with motor disability
  • Alcohol or drug abuse
  • Respiratory disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (15)

  • Kneiss JA, Houck JR, Bukata SV, Puzas JE. Influence of upper extremity assistance on lower extremity force application symmetry in individuals post-hip fracture during the sit-to-stand task. J Orthop Sports Phys Ther. 2012 May;42(5):474-81. doi: 10.2519/jospt.2012.3562. Epub 2012 Apr 30.

    PMID: 22565360BACKGROUND
  • Kneiss JA, Hilton TN, Tome J, Houck JR. Weight-bearing asymmetry in individuals post-hip fracture during the sit to stand task. Clin Biomech (Bristol). 2015 Jan;30(1):14-21. doi: 10.1016/j.clinbiomech.2014.11.012. Epub 2014 Nov 29.

    PMID: 25497603BACKGROUND
  • Edgren J, Rantanen T, Heinonen A, Portegijs E, Alen M, Kiviranta I, Kallinen M, Sipila S. Effects of progressive resistance training on physical disability among older community-dwelling people with history of hip fracture. Aging Clin Exp Res. 2012 Apr;24(2):171-5. doi: 10.1007/BF03325162.

    PMID: 22842835BACKGROUND
  • Portegijs E, Kallinen M, Rantanen T, Heinonen A, Sihvonen S, Alen M, Kiviranta I, Sipila S. Effects of resistance training on lower-extremity impairments in older people with hip fracture. Arch Phys Med Rehabil. 2008 Sep;89(9):1667-74. doi: 10.1016/j.apmr.2008.01.026.

    PMID: 18760151BACKGROUND
  • Portegijs E, Sipila S, Rantanen T, Lamb SE. Leg extension power deficit and mobility limitation in women recovering from hip fracture. Am J Phys Med Rehabil. 2008 May;87(5):363-70. doi: 10.1097/PHM.0b013e318164a9e2.

    PMID: 18303470BACKGROUND
  • Edgren J, Salpakoski A, Rantanen T, Heinonen A, Kallinen M, von Bonsdorff MB, Portegijs E, Sihvonen S, Sipila S. Balance confidence and functional balance are associated with physical disability after hip fracture. Gait Posture. 2013 Feb;37(2):201-5. doi: 10.1016/j.gaitpost.2012.07.001. Epub 2012 Aug 9.

    PMID: 22884315BACKGROUND
  • Host HH, Sinacore DR, Bohnert KL, Steger-May K, Brown M, Binder EF. Training-induced strength and functional adaptations after hip fracture. Phys Ther. 2007 Mar;87(3):292-303. doi: 10.2522/ptj.20050396. Epub 2007 Feb 6.

    PMID: 17284548BACKGROUND
  • Binder EF, Brown M, Sinacore DR, Steger-May K, Yarasheski KE, Schechtman KB. Effects of extended outpatient rehabilitation after hip fracture: a randomized controlled trial. JAMA. 2004 Aug 18;292(7):837-46. doi: 10.1001/jama.292.7.837.

    PMID: 15315998BACKGROUND
  • Houck J, Kneiss J, Bukata SV, Puzas JE. Analysis of vertical ground reaction force variables during a Sit to Stand task in participants recovering from a hip fracture. Clin Biomech (Bristol). 2011 Jun;26(5):470-6. doi: 10.1016/j.clinbiomech.2010.12.004. Epub 2010 Dec 31.

    PMID: 21196069BACKGROUND
  • Miller RR, Eastlack M, Hicks GE, Alley DE, Shardell MD, Orwig DL, Goodpaster BH, Chomentowski PJ, Hawkes WG, Hochberg MC, Ferrucci L, Magaziner J. Asymmetry in CT Scan Measures of Thigh Muscle 2 Months After Hip Fracture: The Baltimore Hip Studies. J Gerontol A Biol Sci Med Sci. 2015 Jun;70(6):753-6. doi: 10.1093/gerona/glr188.

    PMID: 25958401BACKGROUND
  • D'Adamo CR, Hawkes WG, Miller RR, Jones M, Hochberg M, Yu-Yahiro J, Hebel JR, Magaziner J. Short-term changes in body composition after surgical repair of hip fracture. Age Ageing. 2014 Mar;43(2):275-80. doi: 10.1093/ageing/aft198. Epub 2013 Dec 25.

    PMID: 24370941BACKGROUND
  • Penrod JD, Boockvar KS, Litke A, Magaziner J, Hannan EL, Halm EA, Silberzweig SB, Sean Morrison R, Orosz GM, Koval KJ, Siu AL. Physical therapy and mobility 2 and 6 months after hip fracture. J Am Geriatr Soc. 2004 Jul;52(7):1114-20. doi: 10.1111/j.1532-5415.2004.52309.x.

    PMID: 15209649BACKGROUND
  • Magaziner J, Hawkes W, Hebel JR, Zimmerman SI, Fox KM, Dolan M, Felsenthal G, Kenzora J. Recovery from hip fracture in eight areas of function. J Gerontol A Biol Sci Med Sci. 2000 Sep;55(9):M498-507. doi: 10.1093/gerona/55.9.m498.

    PMID: 10995047BACKGROUND
  • Visser M, Harris TB, Fox KM, Hawkes W, Hebel JR, Yahiro JY, Michael R, Zimmerman SI, Magaziner J. Change in muscle mass and muscle strength after a hip fracture: relationship to mobility recovery. J Gerontol A Biol Sci Med Sci. 2000 Aug;55(8):M434-40. doi: 10.1093/gerona/55.8.m434.

    PMID: 10952365BACKGROUND
  • Fox KM, Magaziner J, Hawkes WG, Yu-Yahiro J, Hebel JR, Zimmerman SI, Holder L, Michael R. Loss of bone density and lean body mass after hip fracture. Osteoporos Int. 2000;11(1):31-5. doi: 10.1007/s001980050003.

    PMID: 10663356BACKGROUND

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Robin L Marcus, PhD

    University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D.

Study Record Dates

First Submitted

November 30, 2015

First Posted

December 18, 2015

Study Start

April 1, 2013

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

December 18, 2015

Record last verified: 2015-12