NCT02110875

Brief Summary

The purpose of this study is to learn more about balance and strength in an elderly population (60 and older). Data will be compared between controls and the age/gender- matched PD participants in study "The Effects of vitamin D on Balance in Parkinson's disease" (OHSU IRB # 6482). Specifically a t-test will be used to compare total work and total power on leg extension and flexion, composite SOT score conditions 1-3 and 4-6, response strength and latency on MCT, and turn duration from the iMOBILITY between the two groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

June 1, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 10, 2014

Completed
Last Updated

October 20, 2014

Status Verified

October 1, 2014

Enrollment Period

8 months

First QC Date

April 7, 2014

Last Update Submit

October 17, 2014

Conditions

Keywords

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • Strength (BIODEX)

    The participant's strength will be evaluated using a machine that resembles a stationary exercise bike. They will have one leg and foot strapped onto the machine. Participants will then be asked to flex and extend their leg as quickly as possible five times. This will be repeated with the other leg.

    Visit 1

Secondary Outcomes (1)

  • Balance (SOT)

    Visit 1

Study Arms (1)

CONTROLS

Age- and Gender-Matched Controls

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy Elderly (over 59 years old) without Parkinson's disease or Parkinsonism.

You may qualify if:

  • Over the age of 59
  • Gender and Age-Matched (within 3 years) of main protocol participants

You may not qualify if:

  • Parkinson's disease diagnosis
  • Significant cognitive deficits.
  • Another neurological or orthopedic deficit that in the investigator's opinion would have a significant impact on gait and cognition (e.g. stroke, fracture).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Publications (5)

  • Moreland JD, Richardson JA, Goldsmith CH, Clase CM. Muscle weakness and falls in older adults: a systematic review and meta-analysis. J Am Geriatr Soc. 2004 Jul;52(7):1121-9. doi: 10.1111/j.1532-5415.2004.52310.x.

    PMID: 15209650BACKGROUND
  • Horlings CG, van Engelen BG, Allum JH, Bloem BR. A weak balance: the contribution of muscle weakness to postural instability and falls. Nat Clin Pract Neurol. 2008 Sep;4(9):504-15. doi: 10.1038/ncpneuro0886.

    PMID: 18711425BACKGROUND
  • Rubenstein LZ. Falls in older people: epidemiology, risk factors and strategies for prevention. Age Ageing. 2006 Sep;35 Suppl 2:ii37-ii41. doi: 10.1093/ageing/afl084.

    PMID: 16926202BACKGROUND
  • Inkster LM, Eng JJ, MacIntyre DL, Stoessl AJ. Leg muscle strength is reduced in Parkinson's disease and relates to the ability to rise from a chair. Mov Disord. 2003 Feb;18(2):157-62. doi: 10.1002/mds.10299.

    PMID: 12539208BACKGROUND
  • Allen NE, Canning CG, Sherrington C, Fung VS. Bradykinesia, muscle weakness and reduced muscle power in Parkinson's disease. Mov Disord. 2009 Jul 15;24(9):1344-51. doi: 10.1002/mds.22609.

    PMID: 19425085BACKGROUND

Study Officials

  • Amie L Peterson, MD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 7, 2014

First Posted

April 10, 2014

Study Start

June 1, 2013

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

October 20, 2014

Record last verified: 2014-10

Locations