Strength and Balance in Gender- and Age-Matched Controls

Healthy Volunteers Clinical Trial

— VITDC  

Official title:

Strength and Balance in Gender- and Age-Matched Controls: SubStudy to "The Effects of Vitamin D on Balance in Parkinson's Disease"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02110875
• Other study ID #: e9576
• Status: Completed
• Phase: N/A
• First received: April 7, 2014
• Last updated: October 17, 2014
• Start date: June 2013
• Est. completion date: February 2014

Study information

• Verified date: October 2014
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Description:

Inclusion Criteria:

• Over the age of 59

• Gender and Age-Matched (within 3 years) of main protocol participants

Exclusion Criteria:

• 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).

This study involves one visit to Oregon Health & Science University. The study visit will last approximately 2 hours.

Measurements:

1. The participant's balance will be assessed by having them stand on a platform and completing mental tasks such as naming the alphabet backwards. They will be asked to have their eyes open on some tasks and closed on other tasks. For safety, they will wear a harness like those used by rock climbers.

2. The participant's ability to move and balance will be measured by putting six sensors on their bodies (both wrists, both ankles, chest, and back). Each sensor is about the size and weight of a deck of cards. To measure movement and balance, participants will rise from a chair, walk three feet, turn around, walk back to the chair, and sit down.

3. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Over the age of 59

• Gender and Age-Matched (within 3 years) of main protocol participants

Exclusion Criteria:

• 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).

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Healthy Volunteers

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Rubenstein LZ. Falls in older people: epidemiology, risk factors and strategies for prevention. Age Ageing. 2006 Sep;35 Suppl 2:ii37-ii41. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Balance (SOT)	The participant's balance will be assessed by having them stand on a platform and completing mental tasks such as naming the alphabet backwards. They will be asked to have their eyes open on some tasks and closed on other tasks. For safety, they will wear a harness like those used by rock climbers.	Visit 1	No