Core StabilityNCT04220385

Comparison Between the Effectiveness of Wii Fit Plus and Core Exercise Program in Improving Core Stability in Adults

A study testing Group A and Group B in people with Core Stability, run by Dow University of Health Sciences at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will compare the effectiveness of core stability and Wii fit plus exercise in improving core stability. Group A will perform Wii fit plus exercises and group B will perform core stability exercise. Read more about this study

Who is it for?: Ages 18 to 29 years
Conditions the study is for: Core Stability
What is being tested?: Group A and Group B
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 1 sitePakistan
Study dates: 3 Feb 2020to 21 Nov 2020
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 18 to 29 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Age between 18 to 29 years
Male and female subjects
Trunk flexor endurance less than 144 seconds in male and 149 seconds in female subjects
Trunk extensor endurance less than 146 seconds in male and 189 seconds in female subjects
Flexibility less than 24 cm in male and 27 cm in female.

Who cannot join

Weight more than or equal to 150 kg because it is the maximum limit for balance board
Spinal surgery history,
Current low back pain
Performing exercise in routine
Acute or chronic cardiovascular disease
Acute or chronic musculoskeletal disease
Acute or chronic neurological disease.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

Sindh Institute of Physical Medicine and Rehabilitation
Karachi, Sindh

Other trials in Pakistan

About this study

Conditions: Core Stability
Being tested: Group A, Group B
Keywords: Virtual reality exercise, Exercise Therapy/methods, Health Promotion Physical Endurance/physiology, Core Stability

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Group AOther
Also called Wii fit Plus
Subjects will perform following exercises, Single Leg Extension, Arm and Leg Lift, Balance Bridge, Single-Leg Twist, Single Leg Reach, Sideways Leg Lift, Single Arm Stand, Torso Twists and Plank exercise with minimum one set and maximum two sets. 30 seconds will be rest time between each set. Subjects will be encouraged to increase the number of repetitions after every 2 weeks, except in Plank exercise in which holding position time will be initially 30 seconds in each set and will be encouraged to increase holding time after every 2 weeks.
Group BOther
Also called Core Stability
Subjects will perform Side Bridge, Bird Dog and Beginner Curl-up exercise in the first three weeks and Side Bridge, Bird Dog and Intermediate Curl-up exercise in the last three weeks. Repetitions per set will be 5, 4, 3 in first two weeks, 7, 6, 5 in third and fourth weeks and 9, 8, 7 in last two weeks. 8-10 seconds will be holding time in each repetition. 30 seconds will be rest time between each set

Study groups in NCT04220385
Study group	Role	What they receive
Wii fit Plus	Active comparator	This study group will perform the following Wii fit plus exercises * Single-Leg Extension * Arm and Leg Lift * Balance Bridge * Single-Leg Twist * Single-Leg Reach * Sideways Leg Lift * Single Arm Stand * Torso Twists * Plank Receives: Other: Group A
Core Stability	Active comparator	This study group will perform the following exercises. * Curl-up * Side Bridge * Bird Dog Receives: Other: Group B

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in trunk flexor endurance test
It is expressed in seconds, subject will sit on the test bench and place the upper body against a support with an angle of 60 ° from the test bed. Both the knees and hips will be flexed to 90 °.The arms will be folded across the chest with the hands placed on the opposite shoulder and toes will be placed under toe straps. Subjects will be instructed to maintain the body position while the supporting wedge will be pulled back 10 cm to begin the test. The test will end when the upper body fell below the 60 ° angle.
Measured: Base line and 6 weeks
Change in trunk extensor endurance test
It is recorded in seconds. Subjects will laid prone with the lower body fixed to the test bed at the ankles, knees, and hips and the upper body extended in a cantelevered fashion over the edge of the test bench. The test bench surface will be approximately 25 cm above the surface of the floor. Subjects will rest their upper bodies on the floor before the exertion. At the beginning of the exertion the upper limbs will be held across the chest with the hands resting on the opposite shoulders, and the upper body will be lifted off the floor until the upper torso will be horizontal to the floor. Subjects will be instructed to maintain the horizontal position as long as possible.
Measured: Base line and 6 weeks
Change in sit and reach test
It is expressed in cm.The subject sits without shoes and the soles of the feet flat against a sit-and reach box with the zero mark at the 26 cm. Inner edges of the soles should be 15.2 cm apart.. The subject should slowly reach forward with both hands as far as possible, holding this position approximately 2 s.
Measured: Base line and 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Feb 202021 Nov 2020

First posted7 Jan 2020
Study start3 Feb 2020
Primary completion21 Nov 2020
Study completion21 Nov 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (14)Papers the sponsor has linked to this study.
Other trials for Core StabilityStudies of the same condition, open and under way.
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: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04220385
Sponsor's protocol ID: DUHS/SC/2019/08
Status last verified: Sep 2023
First submitted: 4 Jan 2020
Last updated: 28 Sep 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Akuthota V, Ferreiro A, Moore T, Fredericson M. Core stability exercise principles. Curr Sports Med Rep. 2008 Feb;7(1):39-44. doi: 10.1097/01.CSMR.0000308663.13278.69.
PubMed 18296944
Willson JD, Dougherty CP, Ireland ML, Davis IM. Core stability and its relationship to lower extremity function and injury. J Am Acad Orthop Surg. 2005 Sep;13(5):316-25. doi: 10.5435/00124635-200509000-00005.
PubMed 16148357
Reiman MP, Krier AD, Nelson JA, Rogers MA, Stuke ZO, Smith BS. Comparison of different trunk endurance testing methods in college-aged individuals. Int J Sports Phys Ther. 2012 Oct;7(5):533-9.
PubMed 23091786
Sihawong R, Janwantanakul P, Jiamjarasrangsi W. A prospective, cluster-randomized controlled trial of exercise program to prevent low back pain in office workers. Eur Spine J. 2014 Apr;23(4):786-93. doi: 10.1007/s00586-014-3212-3. Epub 2014 Feb 4.
PubMed 24492949
McGill SM, Childs A, Liebenson C. Endurance times for low back stabilization exercises: clinical targets for testing and training from a normal database. Arch Phys Med Rehabil. 1999 Aug;80(8):941-4. doi: 10.1016/s0003-9993(99)90087-4.
PubMed 10453772
Lopez-Minarro PA, Andujar PS, Rodrnguez-Garcna PL. A comparison of the sit-and-reach test and the back-saver sit-and-reach test in university students. J Sports Sci Med. 2009 Mar 1;8(1):116-22. eCollection 2009.
PubMed 24150564
Zadro JR, Shirley D, Simic M, Mousavi SJ, Ceprnja D, Maka K, Sung J, Ferreira P. Video-Game-Based Exercises for Older People With Chronic Low Back Pain: A Randomized Controlledtable Trial (GAMEBACK). Phys Ther. 2019 Jan 1;99(1):14-27. doi: 10.1093/ptj/pzy112.
PubMed 30247715
Bakar Y, Tugral A, Ozel A, Altuntas YD. Comparison of a 12-Week Whole-Body Exergaming Program on Young Adults: Differentiation in Flexibility, Muscle Strength, Reaction Time, and Walking Speed Between Sexes. Clin Nurs Res. 2020 Sep;29(7):424-432. doi: 10.1177/1054773818797881. Epub 2018 Sep 6.
PubMed 30188176
Neumann S, Meidert U, Barbera-Guillem R, Poveda-Puente R, Becker H. Effects of an Exergame Software for Older Adults on Fitness, Activities of Daily Living Performance, and Quality of Life. Games Health J. 2018 Oct;7(5):341-346. doi: 10.1089/g4h.2017.0079.
PubMed 30325234
Sato K, Kuroki K, Saiki S, Nagatomi R. Improving Walking, Muscle Strength, and Balance in the Elderly with an Exergame Using Kinect: A Randomized Controlled Trial. Games Health J. 2015 Jun;4(3):161-7. doi: 10.1089/g4h.2014.0057. Epub 2015 Jan 28.
PubMed 26182059
Lee D, Lee S, Park J. Effects of indoor horseback riding and virtual reality exercises on the dynamic balance ability of normal healthy adults. J Phys Ther Sci. 2014 Dec;26(12):1903-5. doi: 10.1589/jpts.26.1903. Epub 2014 Dec 25.
PubMed 25540494
Siriphorn A, Chamonchant D. Wii balance board exercise improves balance and lower limb muscle strength of overweight young adults. J Phys Ther Sci. 2015 Jan;27(1):41-6. doi: 10.1589/jpts.27.41. Epub 2015 Jan 9.
PubMed 25642034
Nitz JC, Kuys S, Isles R, Fu S. Is the Wii Fit a new-generation tool for improving balance, health and well-being? A pilot study. Climacteric. 2010 Oct;13(5):487-91. doi: 10.3109/13697130903395193.
PubMed 19905991
Schilling JF, Murphy JC, Bonney JR, Thich JL. Effect of core strength and endurance training on performance in college students: randomized pilot study. J Bodyw Mov Ther. 2013 Jul;17(3):278-90. doi: 10.1016/j.jbmt.2012.08.008. Epub 2012 Sep 15.
PubMed 23768270

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Core Stability trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison Between the Effectiveness of Wii Fit Plus and Core Exercise Program in Improving Core Stability in Adults
ClinicalTrials.gov ID: NCT04220385
Acronym / sponsor ID: DUHS/SC/2019/08
Conditions: Core Stability
Keywords: Virtual reality exercise, Exercise Therapy/methods, Health Promotion Physical Endurance/physiology, Core Stability
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Dow University of Health SciencesUniversity, hospital or other
Study start: 3 Feb 2020 (actual)
Primary completion: 21 Nov 2020 (actual)
Study completion: 21 Nov 2020 (actual)
First posted: 7 Jan 2020 (actual)
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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Wii fit Plus	Active comparator	Other: Group AThis study group will perform the following Wii fit plus exercises * Single-Leg Extension * Arm and Leg Lift * Balance Bridge * Single-Leg Twist * Single-Leg Reach * Sideways Leg Lift * Single Arm Stand * Torso Twists * Plank
Core Stability	Active comparator	Other: Group BThis study group will perform the following exercises. * Curl-up * Side Bridge * Bird Dog

Who may qualify

Ages: 18 to 29 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Age between 18 to 29 years
Male and female subjects
Trunk flexor endurance less than 144 seconds in male and 149 seconds in female subjects
Trunk extensor endurance less than 146 seconds in male and 189 seconds in female subjects
Flexibility less than 24 cm in male and 27 cm in female.

Key exclusion criteria (7 listed)

Weight more than or equal to 150 kg because it is the maximum limit for balance board
Spinal surgery history,
Current low back pain
Performing exercise in routine
Acute or chronic cardiovascular disease

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
Group AAlso: Wii fit PlusSubjects will perform following exercises, Single Leg Extension, Arm and Leg Lift, Balance Bridge, Single-Leg Twist, Single Leg Reach, Sideways Leg Lift, Single Arm Stand, Torso Twists and Plank exercise with minimum one set and maximum two sets. 30 seconds will be rest time between each set. Subjects will be encouraged to increase the number of repetitions after every 2 weeks, except in Plank exercise in which holding position time will be initially 30 seconds in each set and will be encouraged to increase holding time after every 2 weeks.	Other	Wii fit Plus
Group BAlso: Core StabilitySubjects will perform Side Bridge, Bird Dog and Beginner Curl-up exercise in the first three weeks and Side Bridge, Bird Dog and Intermediate Curl-up exercise in the last three weeks. Repetitions per set will be 5, 4, 3 in first two weeks, 7, 6, 5 in third and fourth weeks and 9, 8, 7 in last two weeks. 8-10 seconds will be holding time in each repetition. 30 seconds will be rest time between each set	Other	Core Stability

Primary outcome

Change in trunk flexor endurance test
Time frame: Base line and 6 weeks
It is expressed in seconds, subject will sit on the test bench and place the upper body against a support with an angle of 60 ° from the test bed. Both the knees and hips will be flexed to 90 °.The arms will be folded across the chest with the hands placed on the opposite shoulder and toes will be placed under toe straps. Subjects will be instructed to maintain the body position while the supporting wedge will be pulled back 10 cm to begin the test. The test will end when the upper body fell below the 60 ° angle.
Change in trunk extensor endurance test
Time frame: Base line and 6 weeks
It is recorded in seconds. Subjects will laid prone with the lower body fixed to the test bed at the ankles, knees, and hips and the upper body extended in a cantelevered fashion over the edge of the test bench. The test bench surface will be approximately 25 cm above the surface of the floor. Subjects will rest their upper bodies on the floor before the exertion. At the beginning of the exertion the upper limbs will be held across the chest with the hands resting on the opposite shoulders, and the upper body will be lifted off the floor until the upper torso will be horizontal to the floor. Subjects will be instructed to maintain the horizontal position as long as possible.
Change in sit and reach test
Time frame: Base line and 6 weeks
It is expressed in cm.The subject sits without shoes and the soles of the feet flat against a sit-and reach box with the zero mark at the 26 cm. Inner edges of the soles should be 15.2 cm apart.. The subject should slowly reach forward with both hands as far as possible, holding this position approximately 2 s.

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 28 Sep 2023.
Background: PubMed 18296944Akuthota V, Ferreiro A, Moore T, Fredericson M. Core stability exercise principles. Curr Sports Med Rep. 2008 Feb;7(1):39-44. doi: 10.1097/01.CSMR.0000308663.13278.69.
Background: PubMed 16148357Willson JD, Dougherty CP, Ireland ML, Davis IM. Core stability and its relationship to lower extremity function and injury. J Am Acad Orthop Surg. 2005 Sep;13(5):316-25. doi: 10.5435/00124635-200509000-00005.
Background: PubMed 23091786Reiman MP, Krier AD, Nelson JA, Rogers MA, Stuke ZO, Smith BS. Comparison of different trunk endurance testing methods in college-aged individuals. Int J Sports Phys Ther. 2012 Oct;7(5):533-9.
Background: PubMed 24492949Sihawong R, Janwantanakul P, Jiamjarasrangsi W. A prospective, cluster-randomized controlled trial of exercise program to prevent low back pain in office workers. Eur Spine J. 2014 Apr;23(4):786-93. doi: 10.1007/s00586-014-3212-3. Epub 2014 Feb 4.
Background: PubMed 10453772McGill SM, Childs A, Liebenson C. Endurance times for low back stabilization exercises: clinical targets for testing and training from a normal database. Arch Phys Med Rehabil. 1999 Aug;80(8):941-4. doi: 10.1016/s0003-9993(99)90087-4.
Background: PubMed 24150564Lopez-Minarro PA, Andujar PS, Rodrnguez-Garcna PL. A comparison of the sit-and-reach test and the back-saver sit-and-reach test in university students. J Sports Sci Med. 2009 Mar 1;8(1):116-22. eCollection 2009.
Background: PubMed 30247715Zadro JR, Shirley D, Simic M, Mousavi SJ, Ceprnja D, Maka K, Sung J, Ferreira P. Video-Game-Based Exercises for Older People With Chronic Low Back Pain: A Randomized Controlledtable Trial (GAMEBACK). Phys Ther. 2019 Jan 1;99(1):14-27. doi: 10.1093/ptj/pzy112.
Background: PubMed 30188176Bakar Y, Tugral A, Ozel A, Altuntas YD. Comparison of a 12-Week Whole-Body Exergaming Program on Young Adults: Differentiation in Flexibility, Muscle Strength, Reaction Time, and Walking Speed Between Sexes. Clin Nurs Res. 2020 Sep;29(7):424-432. doi: 10.1177/1054773818797881. Epub 2018 Sep 6.
Background: PubMed 30325234Neumann S, Meidert U, Barbera-Guillem R, Poveda-Puente R, Becker H. Effects of an Exergame Software for Older Adults on Fitness, Activities of Daily Living Performance, and Quality of Life. Games Health J. 2018 Oct;7(5):341-346. doi: 10.1089/g4h.2017.0079.
Background: PubMed 26182059Sato K, Kuroki K, Saiki S, Nagatomi R. Improving Walking, Muscle Strength, and Balance in the Elderly with an Exergame Using Kinect: A Randomized Controlled Trial. Games Health J. 2015 Jun;4(3):161-7. doi: 10.1089/g4h.2014.0057. Epub 2015 Jan 28.
Background: PubMed 25540494Lee D, Lee S, Park J. Effects of indoor horseback riding and virtual reality exercises on the dynamic balance ability of normal healthy adults. J Phys Ther Sci. 2014 Dec;26(12):1903-5. doi: 10.1589/jpts.26.1903. Epub 2014 Dec 25.
Background: PubMed 25642034Siriphorn A, Chamonchant D. Wii balance board exercise improves balance and lower limb muscle strength of overweight young adults. J Phys Ther Sci. 2015 Jan;27(1):41-6. doi: 10.1589/jpts.27.41. Epub 2015 Jan 9.
Individual participant dataSharing planned: No

Related trials for Core Stability

Recruiting
Comparison of Vestibular Stimulation and Core Stability Training on Sitting Balance in Hypotonic CP
Hypotonic Cerebral Palsy
Not yet recruiting
Core Strength Training, Anthropometry, and Postural Control in Youth Optimist Sailors
Postural Control, Athletic Performance
Not yet recruiting
Integrated Core Stability Exercises and Yoga Program on Premenstrual Syndrome
Premenstrual Syndrome
Not yet recruiting
Effects of Dead Bug Exercises With and Without Diaphragmatic Breathing in Patients With Chronic Non-specific Low Back Pain.
Non-specific Chronic Low Back Pain
Not yet recruiting
"CORE Training for Musculoskeletal Health: A Study on Adaptive Exercise Protocols"
Core Muscle Weakness, Postural Control Deficit

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.

Tabish Husain Siddiqui, DPT, MSAPT* principal investigator

Dow University of Health Sciences

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Group A and Group B in people with Core Stability, run by Dow University of Health Sciences at 1 site in Pakistan.

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 5 inclusion and 7 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 28 Sep 2023. 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 Pakistan. 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. 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?

Change in trunk flexor endurance test (time frame: Base line and 6 weeks). The study lists 3 primary outcomes in all. 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 NCT04220385, which also lists 14 linked publications.

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 28 Sep 2023.