Assessing Balance Changes Following an Exercise Program Among Middle-Aged Adults

This graduate student research study has two purposes; the first purpose is to examine the criterion validity of the Y Balance Test (YBT) with the Limits of Stability Test (LOS) in healthy middle-aged adults. The second purpose is to examine balance changes using the YBT following a home-based exercise program.

Study Overview

• Status: Completed
• Conditions: Balance Changes
• Intervention / Treatment: Other: home exercise program; Other: non exercise program

Detailed Description

4. "Subjects will be healthy female or male middle-aged adults who are able to walk and move independently.

5. "Subjects will be between 45 and 64 years of age." 6. "In total, subject participation will last approximately eight weeks. Visit 1 (baseline): 90 minutes, visit 2 (week 4): 30 minutes, and visit 3 (week 8): 60 minutes.

7. "Subjects will be recruited by distributing flyers in the Loma Linda Community, sending emails to school staff, students, and faculty, and word of mouth.

8. "Consent will take place at Loma Linda University, Nichol Hall rooms A620 -A640 by investigators." 9. If Multi-center: N/A 10. If Single center or investigator-initiated: "70 subjects will participate in the study."

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92350
      • Loma Linda University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:• Healthy adults.

• Age range: 45-64 years.
• Able to walk and move independently

Exclusion Criteria:• Dizziness, visual or neurological disorders that prevent the ability to complete the testing protocol.

• Lower limb injury in the last 3 months.
• Lower limb surgery in the last 6 months.
• Current involvement in a rehabilitation program.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: home exercise program; • The exercise group will follow a home exercise protocol for eight weeks: that involves standing on one foot, walking, and doing wall squats.	Other: home exercise program; Subjects in the exercise group will be instructed to follow the intervention protocol for eight weeks. The intervention consists of five exercises: standing on one foot, walking heel to toe, heel walking, side kicks, and wall squats. Each exercise will be repeated three times per week for eight weeks.
Active Comparator: non exercise group; • The non-exercise group will continue with their usual life style	Other: non exercise program; continue usual lifestyle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Y Balance Test	The test assesses performance during single-leg balance with a reaching task in the anterior (ANT), posteromedial (PM), and posterolateral (PL) directions to determine lower extremity movement asymmetry and balance deficits. ANT, PM, and PL are a composite measurement.	change from baseline to 4 weeks
Y Balance Test	The test assesses performance during single-leg balance with a reaching task in the anterior (ANT), posteromedial (PM), and posterolateral (PL) directions to determine lower extremity movement asymmetry and balance deficits. ANT, PM, and PL are a composite measurement.	change from 4 weeks to 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
limits of stability	Limits of Stability measure five parameters: reaction time (RT), movement velocity (MVL), endpoint excursion (EPE), maximum excursion (MXE), and directional control (DC). RT, MVL, EPE, MXE, and DC are composite measures.	change from baseline to 4 weeks
limits of stability	Limits of Stability measure five parameters: reaction time (RT), movement velocity (MVL), endpoint excursion (EPE), maximum excursion (MXE), and directional control (DC). RT, MVL, EPE, MXE, and DC are composite measures.	change from 4 weeks to 8 weeks

Collaborators and Investigators

• Sponsor: Loma Linda University
• Investigators: Principal Investigator: Gurinder Bains, PhD, Loma Linda University

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2016
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: March 15, 2017
• First Submitted That Met QC Criteria: May 18, 2017
• First Posted (Actual): May 19, 2017

Study Record Updates

• Last Update Posted (Actual): July 10, 2019
• Last Update Submitted That Met QC Criteria: July 8, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 5160196

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No