FallsNCT01897467
Effect of a Wii Fit Intervention on Components of Fall Risk in Middle-aged Women
A study testing Wii Fit in people with Falls and Osteopenia, run by Arizona State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Falls, Osteopenia
- What is being tested?
- Wii Fit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Feb 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
United States1 site
Arizona Biomedical Collaborative
Phoenix, Arizona, 85004
About this study
Official title: Effect of a Wii Fit Intervention on Balance, Muscular Fitness, and Bone Health 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.
Read more
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.
- Conditions
- Falls, Osteopenia
- Being tested
- Wii Fit, Wait-List Control
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wii FitBehavioural
Also called Nintendo Wii Fit Intervention
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 ControlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | 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. Receives: Behavioral: Wait-List Control |
| Wii Fit | Experimental | 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. Receives: Behavioral: Wii Fit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance
Balance will be assessed using the Berg Balance Scale and the FICSIT-4 at baseline, 6-weeks, and 12-weeks.
Measured: 12 weeks
Secondary outcomes (2)
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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2013 (estimated)
- Study startAug 2013
- Primary completionJan 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FallsStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah J Wherry, MS, Principal investigator, Arizona State UniversityPamela D Swan, PhD, Study chair, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01897467
- Sponsor's protocol ID
- WiiFit
- Status last verified
- Jan 2016
- First submitted
- 9 Jul 2013
- Last updated
- 8 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31310993
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Wii Fit Intervention on Balance, Muscular Fitness, and Bone Health in Middle-aged Women
- ClinicalTrials.gov ID
- NCT01897467
- Acronym / sponsor ID
- WiiFit
- Conditions
- Falls, Osteopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 12 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Behavioral: Wait-List ControlThe 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. |
| Wii Fit | Experimental | Behavioral: Wii FitParticipants 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. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wii FitAlso: Nintendo Wii Fit InterventionExercises 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. | Behavioural | Wii Fit |
| Wait-List ControlParticipants 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. | Behavioural | Control |
Primary outcome
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.
2 secondary outcomes
Muscular Fitness
Time frame: 12 weeks
Bone Turnover
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2016.
- Derived from this study: PubMed 31310993Wherry 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah J Wherry, MS principal investigator
Arizona State University
Pamela D Swan, PhD study chair
Arizona State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wii Fit in people with Falls and Osteopenia, run by Arizona State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01897467, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2016.