NCT04213560

Brief Summary

Purposes: 1) To determine the effects of weighted waist-hooping on balance in healthy individuals and 2) to observe whether these effects are attributed to neuromuscular conditioning or core strength gains. Methods: 27 females (ages 20-45) were included, 15 in the intervention group, and 12 in the control. The intervention consisted of six weeks of weighted waist-hooping four times a week for 10 minutes each session. Balance was assessed pre and post intervention using the BESS, SEBT, and Neurocom SOT. Core strength was assessed using hold duration of a bilateral and unilateral plank.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Dec 2016

Longer than P75 for not_applicable healthy

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 30, 2019

Completed
Last Updated

January 9, 2024

Status Verified

January 1, 2024

Enrollment Period

2 years

First QC Date

December 18, 2019

Last Update Submit

January 5, 2024

Conditions

Keywords

Weighted waist-hoopingBalanceProprioceptionNeurocom

Outcome Measures

Primary Outcomes (10)

  • Balance Error Scoring System (BESS)

    Participants were instructed to maintain each of the 6 positions for as long as possible and to continue to try until the 20 seconds were complete even if balance was lost, which was counted as an error along with the specific error criteria for this assessment. Total number of errors were recorded for each position according and the summated to provide a total error score. A higher score indicates greater occurrence of error and thus poorer balance.

    baseline

  • Balance Error Scoring System (BESS)

    Participants were instructed to maintain each of the 6 positions for as long as possible and to continue to try until the 20 seconds were complete even if balance was lost, which was counted as an error along with the specific error criteria for this assessment. Total number of errors were recorded for each position according and the summated to provide a total error score. A higher score indicates greater occurrence of error and thus poorer balance.

    6 - weeks

  • Star Excursion Balance Test (SEBT)

    SEBT was conducted for both the right and left leg reaching. Position on the start was used to indicate where to reach. Reaching across the body with the right foot to the left side and reaching across the body with the left foot to the right side were both defined as a medial reach for the purpose of this study.

    baseline

  • Star Excursion Balance Test (SEBT)

    SEBT was conducted for both the right and left leg reaching. Position on the start was used to indicate where to reach. Reaching across the body with the right foot to the left side and reaching across the body with the left foot to the right side were both defined as a medial reach for the purpose of this study.

    6 - weeks

  • equilibrium scores (EQ scores) of the Sensory Organization Test (SOT) on the NeuroCom

    The SOT parses out contributions and functionality of the visual, somatosensory, and vestibular systems provide information regarding the effects of each system on postural control.8 The EQ score is a composite score calculated by the NeuroCom by weighting each of the 6 conditions of typical and altered stimuli. A score closer to 100 indicates less postural sway and a score closer to 0 indicates more postural sway and increased likelihood of fall.8 An increase in EQ score indicates an improvement in postural control and potentially sensory selection since the purpose of the SOT is to determine if patients are able to appropriately reweight their senses in response to the six different conditions in an effort to maintain postural control.

    baseline

  • equilibrium scores (EQ scores) of the Sensory Organization Test (SOT) on the NeuroCom

    The SOT parses out contributions and functionality of the visual, somatosensory, and vestibular systems provide information regarding the effects of each system on postural control.8 The EQ score is a composite score calculated by the NeuroCom by weighting each of the 6 conditions of typical and altered stimuli. A score closer to 100 indicates less postural sway and a score closer to 0 indicates more postural sway and increased likelihood of fall.8 An increase in EQ score indicates an improvement in postural control and potentially sensory selection since the purpose of the SOT is to determine if patients are able to appropriately reweight their senses in response to the six different conditions in an effort to maintain postural control.

    6 - weeks

  • Core Strength position 1

    hold a standard bilateral plank position to assess core strength. The duration of time the participant was able to hold each position was recorded. If the participant was unable to attain proper form or unable to complete the task the duration of hold was recorded as 0 seconds. These assessments were conducted before and after the weighted waist-hooping intervention.

    baseline

  • Core Strength position 1

    hold a standard bilateral plank position to assess core strength. The duration of time the participant was able to hold each position was recorded. If the participant was unable to attain proper form or unable to complete the task the duration of hold was recorded as 0 seconds. These assessments were conducted before and after the weighted waist-hooping intervention.

    6 - weeks

  • Core Strength position 2

    hold a unilateral plank with the dominant leg raised position to assess core strength. The duration of time the participant was able to hold the position was recorded. If the participant was unable to attain proper form or unable to complete the task the duration of hold was recorded as 0 seconds. These assessments were conducted before and after the weighted waist-hooping intervention.

    baseline

  • Core Strength position 2

    hold a unilateral plank with the dominant leg raised position to assess core strength. The duration of time the participant was able to hold the position was recorded. If the participant was unable to attain proper form or unable to complete the task the duration of hold was recorded as 0 seconds. These assessments were conducted before and after the weighted waist-hooping intervention.

    6 - weeks

Study Arms (2)

Weighted waist-hooping

EXPERIMENTAL

Participants weighted waist-hooping on their own for ten minutes a day, four days a week, for six weeks resulting in a total of 40 minutes of weighted waist-hooping each week. Participants weighted waist-hooped with a three-pound weighted hula hoop at the waist for ten minutes. Half time hooping to the left and the other half hooping to the right. If discomfort while hooping occurred participants were instructed to take breaks, change directions more frequently, or where thicker clothing to lessen the impact of the hoop around their waists. The investigators would check in on the participants weekly to provide feedback on technique and answer all questions throughout the six-week intervention.

Device: weighted waist-hooping

Control

NO INTERVENTION

No Intervention

Interventions

weighted waist-hooping

Weighted waist-hooping

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy women age 18-45.

You may not qualify if:

  • pregnancy and vertigo

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 18, 2019

First Posted

December 30, 2019

Study Start

December 15, 2016

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

January 9, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share