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Effect of a Wii Fit Intervention on Components of Fall Risk in Middle-aged Women

Primary Purpose

Falls, Osteopenia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Wii Fit
Wait-List Control
Sponsored by
Arizona State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Falls

Eligibility Criteria

45 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • apparently healthy women between the ages of 45-60
  • no contraindications to walking or standing
  • no hormonal replacement therapy or any medications or supplements (except for calcium, vitamin D, multivitamin) that affect the bone
  • Any vitamin supplements must be over-the-counter (OTC) and cannot be prescription grade.

Exclusion Criteria:

  • Those who do not pass the PAR-Q+ (contraindicated for exercise)
  • DXA t-score greater than 0 (Note: any woman who has a t-score less than -1.5 will be referred to their health care provider for further follow up and will not be allowed in the study with the approval of their health care professional.)

Sites / Locations

  • Arizona Biomedical Collaborative

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control

Wii Fit

Arm Description

The control is a "wait-list" control, and will have the option to participate in the intervention at the end of the initial 12-week study period. The control group will be asked to not change any of their dietary or exercise habits over the course of the 12 weeks.

Participants in the intervention group will be assigned a Wii console and a Wii Fit balance board. The intervention group will be asked to play for 30 minutes a day, 3 times per week, using only the participant profile pre-programmed for them. They will complete yoga poses and strength training exercises for the first 10 minutes and balance coordination games for the remaining 20 minutes. They will be asked to complete each exercise at least twice, preferably by cycling through all exercises. Participants will be asked to do all of the exercises in one 30-minute session, rather than breaking them up throughout the day. All participants will be asked to keep a record of which games they play and for how long. The Wii Fit software also keeps a digital record of which exercises were completed and how long they were performed. At the end of the intervention the investigator will use the information stored in the Wii, as well as activity logs, to assess compliance.

Outcomes

Primary Outcome Measures

Balance
Balance will be assessed using the Berg Balance Scale and the FICSIT-4 at baseline, 6-weeks, and 12-weeks.

Secondary Outcome Measures

Muscular Fitness
Muscular strength and endurance will be assessed using an isokinetic dynamometer. The strength protocol will involve 60 degrees/second, 180 degrees/second, and 240 degrees/second. Muscular endurance will be assessed via 50 repetitions at 240 degrees/second. Testing will occur at baseline, 6 weeks, and 12 weeks.
Bone Turnover
Biomarkers of bone turnover (osteocalcin and c-telopeptide) will be assessed via venous blood draw at baseline, 6 weeks, and 12 weeks.

Full Information

First Posted
July 9, 2013
Last Updated
January 6, 2016
Sponsor
Arizona State University
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1. Study Identification

Unique Protocol Identification Number
NCT01897467
Brief Title
Effect of a Wii Fit Intervention on Components of Fall Risk in Middle-aged Women
Official Title
Effect of a Wii Fit Intervention on Balance, Muscular Fitness, and Bone Health in Middle-aged Women
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arizona State University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Losses of muscular fitness/balance are common occurrences with aging that can lead to an increased fall-risk. The accelerated bone loss that may accompany menopause makes some women even more "at-risk" for serious consequences related to falling. Interventions to reduce fall-risk have been conducted in an attempt to improve balance or muscular fitness, but often these interventions require monotonous exercises that don't arouse enough long-term interest to elicit the improvements. In other words, while the intervention may be beneficial, participants quit before they can realize any gains. Currently, there is little research that uses novel technology-based programs to promote balance exercises among middle-aged women. The Wii Fit system includes various strength and balance exercises integrated into games intended to have the participant have fun and retain interest, while also improving fitness. By using such a program, women could potentially improve their balance and decrease their fall risk in a way that is fun and exciting. The purpose of this study is to investigate the effect of a Wii Fit based exercise program on balance/muscular fitness/markers of bone health in women between the ages of 45-60 with low bone mass. Volunteers who have moderately low bone levels (n = 28) will be randomly assigned to either the Wii Fit exercise intervention or a normally active control. Balance ability, muscular fitness, body composition, physical activity levels and markers of bone health will be assessed before and after the intervention. Each participant in the intervention will be provided a pre-programmed Wii Fit console and balance board to use at home. The intervention will consist of a 12-week program that they perform 30 minutes a day 3 days a week. The exercises include 10 minutes of Yoga poses and strength exercises and then 20 minutes of balance games such as soccer heading, ski slalom and table tilt. At the 6 week point and the conclusion of the intervention, participants will come to the lab for testing on the same tests done initially. The overall goal of this study is to gauge the efficacy of this intervention to improve balance, fitness, and bone health in at-risk women. This project is important because it offers an exciting, fun, and motivating way to impact fall-risk before clinical symptoms develop. Overall, this intervention could significantly reduce healthcare dollars spent on fall-related outcomes, as well as reduce fall-related mortality.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Falls, Osteopenia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
The control is a "wait-list" control, and will have the option to participate in the intervention at the end of the initial 12-week study period. The control group will be asked to not change any of their dietary or exercise habits over the course of the 12 weeks.
Arm Title
Wii Fit
Arm Type
Experimental
Arm Description
Participants in the intervention group will be assigned a Wii console and a Wii Fit balance board. The intervention group will be asked to play for 30 minutes a day, 3 times per week, using only the participant profile pre-programmed for them. They will complete yoga poses and strength training exercises for the first 10 minutes and balance coordination games for the remaining 20 minutes. They will be asked to complete each exercise at least twice, preferably by cycling through all exercises. Participants will be asked to do all of the exercises in one 30-minute session, rather than breaking them up throughout the day. All participants will be asked to keep a record of which games they play and for how long. The Wii Fit software also keeps a digital record of which exercises were completed and how long they were performed. At the end of the intervention the investigator will use the information stored in the Wii, as well as activity logs, to assess compliance.
Intervention Type
Behavioral
Intervention Name(s)
Wii Fit
Other Intervention Name(s)
Nintendo Wii Fit Intervention
Intervention Description
Exercises to be done on the Wii Fit include: warrior pose, half-moon pose, lunges, side lunges, balance bubble, ski slalom, soccer heading, and table tilt.
Intervention Type
Behavioral
Intervention Name(s)
Wait-List Control
Intervention Description
Participants maintain currently physical activity and diet habits for 12 weeks. They have the option to participate in the intervention at the end of the 12-week period, but it is not mandatory.
Primary Outcome Measure Information:
Title
Balance
Description
Balance will be assessed using the Berg Balance Scale and the FICSIT-4 at baseline, 6-weeks, and 12-weeks.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Muscular Fitness
Description
Muscular strength and endurance will be assessed using an isokinetic dynamometer. The strength protocol will involve 60 degrees/second, 180 degrees/second, and 240 degrees/second. Muscular endurance will be assessed via 50 repetitions at 240 degrees/second. Testing will occur at baseline, 6 weeks, and 12 weeks.
Time Frame
12 weeks
Title
Bone Turnover
Description
Biomarkers of bone turnover (osteocalcin and c-telopeptide) will be assessed via venous blood draw at baseline, 6 weeks, and 12 weeks.
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Body Composition
Description
Total lean mass and fat mass will be assessed via dual-energy x-ray absorptiometry at baseline and 12 weeks.
Time Frame
12 weeks
Title
Bone Mineral Density
Description
Bone mineral density (total body) will be assessed via dual-energy x-ray absorptiometry at baseline and 12 weeks.
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: apparently healthy women between the ages of 45-60 no contraindications to walking or standing no hormonal replacement therapy or any medications or supplements (except for calcium, vitamin D, multivitamin) that affect the bone Any vitamin supplements must be over-the-counter (OTC) and cannot be prescription grade. Exclusion Criteria: Those who do not pass the PAR-Q+ (contraindicated for exercise) DXA t-score greater than 0 (Note: any woman who has a t-score less than -1.5 will be referred to their health care provider for further follow up and will not be allowed in the study with the approval of their health care professional.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah J Wherry, MS
Organizational Affiliation
Arizona State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pamela D Swan, PhD
Organizational Affiliation
Arizona State University
Official's Role
Study Chair
Facility Information:
Facility Name
Arizona Biomedical Collaborative
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31310993
Citation
Wherry SJ, Ananian C, Swan PD. Feasibility of a Home-Based Balance Intervention in Middle-Aged Women Using Wii Fit Plus(R). J Phys Act Health. 2019 Sep 1;16(9):736-744. doi: 10.1123/jpah.2018-0265. Epub 2019 Jul 17.
Results Reference
derived

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Effect of a Wii Fit Intervention on Components of Fall Risk in Middle-aged Women

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