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OpenTrials
Completed

NCT Number: NCT01897467

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

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.

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Key information

Age range

45 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Arizona Biomedical Collaborative

Phoenix, Arizona, 85004, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Wii Fit

Behavioral

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.

Other names: Nintendo Wii Fit Intervention

Wait-list control

Behavioral

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 outcomes

  1. Balance

    Time frame: 12 weeks

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

Secondary outcomes

  1. Muscular Fitness

    Time frame: 12 weeks

    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.

  2. Bone Turnover

    Time frame: 12 weeks

    Biomarkers of bone turnover (osteocalcin and c-telopeptide) will be assessed via venous blood draw at baseline, 6 weeks, and 12 weeks.

Other outcomes

  1. Body Composition

    Time frame: 12 weeks

    Total lean mass and fat mass will be assessed via dual-energy x-ray absorptiometry at baseline and 12 weeks.

  2. Bone Mineral Density

    Time frame: 12 weeks

    Bone mineral density (total body) will be assessed via dual-energy x-ray absorptiometry at baseline and 12 weeks.

Sponsors and collaborators

Lead sponsor

Arizona State University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 12, 2013
Registry last updated
Jan 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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