Clinical trial NCT01897467: 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
Overall status: COMPLETED
Phase: NA
Conditions: Falls
Osteopenia
Lead sponsor: Arizona State University
Sponsor class: OTHER
First posted: 2013-07-12
Enrollment: 24
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.)

Primary outcomes:
measure: Balance
timeFrame: 12 weeks
Secondary outcomes:
measure: Muscular Fitness
timeFrame: 12 weeks
measure: Bone Turnover
timeFrame: 12 weeks
Other outcomes:
measure: Body Composition
timeFrame: 12 weeks
measure: Bone Mineral Density
timeFrame: 12 weeks
Locations:
city: Phoenix
country: United States
facility: Arizona Biomedical Collaborative
state: Arizona
Study officials:
affiliation: Arizona State University
name: Sarah J Wherry, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Arizona State University
name: Pamela D Swan, PhD
role: STUDY_CHAIR
References:
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.