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

Osteopenia Clinical Trial

Official title:

Effect of a Wii Fit Intervention on Balance, Muscular Fitness, and Bone Health in Middle-aged Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01897467
• Other study ID #: WiiFit
• Status: Completed
• Phase: N/A
• First received: July 9, 2013
• Last updated: January 6, 2016
• Start date: August 2013
• Est. completion date: February 2014

Study information

• Verified date: January 2016
• Source: Arizona State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 60 Years

Eligibility

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.)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Falls
• Osteopenia

Intervention

Behavioral:
• Wii Fit
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.
• Wait-List Control
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.

Locations

Country	Name	City	State
United States	Arizona Biomedical Collaborative	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Arizona State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Body Composition	Total lean mass and fat mass will be assessed via dual-energy x-ray absorptiometry at baseline and 12 weeks.	12 weeks	No
Other	Bone Mineral Density	Bone mineral density (total body) will be assessed via dual-energy x-ray absorptiometry at baseline and 12 weeks.	12 weeks	No
Primary	Balance	Balance will be assessed using the Berg Balance Scale and the FICSIT-4 at baseline, 6-weeks, and 12-weeks.	12 weeks	No
Secondary	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.	12 weeks	No
Secondary	Bone Turnover	Biomarkers of bone turnover (osteocalcin and c-telopeptide) will be assessed via venous blood draw at baseline, 6 weeks, and 12 weeks.	12 weeks	No