NCT04220385

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 7, 2020

Completed
27 days until next milestone

Study Start

First participant enrolled

February 3, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2020

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

10 months

First QC Date

January 4, 2020

Last Update Submit

September 26, 2023

Conditions

Core Stability

Keywords

Virtual reality exerciseExercise Therapy/methodsHealth Promotion Physical Endurance/physiologyCore Stability

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    Base line and 6 weeks

Study Arms (2)

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

Other: Group A

Core Stability

ACTIVE COMPARATOR

This study group will perform the following exercises. * Curl-up * Side Bridge * Bird Dog

Other: Group B

Interventions

Group AOTHER

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.

Also known as: Wii fit Plus
Wii fit Plus
Group BOTHER

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

Also known as: Core Stability
Core Stability

Eligibility Criteria

Age18 Years - 29 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sindh Institute of Physical Medicine and Rehabilitation

Karachi, Sindh, Pakistan

Location

Related Publications (14)

  • 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.

    PMID: 18296944BACKGROUND

  • 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.

    PMID: 16148357BACKGROUND

  • 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.

    PMID: 23091786BACKGROUND

  • 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.

    PMID: 24492949BACKGROUND

  • 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.

    PMID: 10453772BACKGROUND

  • 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.

    PMID: 24150564BACKGROUND

  • 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.

    PMID: 30247715BACKGROUND

  • 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.

    PMID: 30188176BACKGROUND

  • 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.

    PMID: 30325234BACKGROUND

  • 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.

    PMID: 26182059BACKGROUND

  • 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.

    PMID: 25540494BACKGROUND

  • 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.

    PMID: 25642034BACKGROUND

  • 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.

    PMID: 19905991BACKGROUND

  • 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.

    PMID: 23768270BACKGROUND

MeSH Terms

Interventions

Core Stability

Intervention Hierarchy (Ancestors)

Postural BalanceProprioceptionVestibulocochlear Physiological PhenomenaPhysiological PhenomenaMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaSensationNervous System Physiological Phenomena

Study Officials

  • Tabish Husain Siddiqui, DPT, MSAPT*

    Dow University of Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 4, 2020

First Posted

January 7, 2020

Study Start

February 3, 2020

Primary Completion

November 21, 2020

Study Completion

November 21, 2020

Last Updated

September 28, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)