HealthyNCT04213560
The Effects of Weighted Waist-Hooping
A study testing weighted waist-hooping in people with Healthy, run by The Sage Colleges.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- weighted waist-hooping
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2016to 31 Dec 2018
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy women age 18-45.
Who cannot join
- pregnancy and vertigo
About this study
Official title: The Effects of Weighted Waist-Hooping on Balance, Proprioception, and Body Awareness
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.
- Conditions
- Healthy
- Being tested
- weighted waist-hooping
- Keywords
- Weighted waist-hooping, Balance, Proprioception, Neurocom
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
weighted waist-hoopingDevice
weighted waist-hooping
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: weighted waist-hooping |
| Control | No intervention | No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 - weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2019
- Study start15 Dec 2016
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Sage Colleges
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brittney Muir, The Sage Colleges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04213560
- Sponsor's protocol ID
- 545-2016-2017
- Status last verified
- Jan 2024
- First submitted
- 18 Dec 2019
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Weighted Waist-Hooping on Balance, Proprioception, and Body Awareness
- ClinicalTrials.gov ID
- NCT04213560
- Acronym / sponsor ID
- 545-2016-2017
- Conditions
- Healthy
- Keywords
- Weighted waist-hooping, Balance, Proprioception, Neurocom
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- The Sage CollegesUniversity, hospital or other
- Study start
- 15 Dec 2016 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 30 Dec 2019 (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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weighted waist-hooping | Experimental | Device: weighted waist-hoopingParticipants 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. |
| Control | No intervention | –No Intervention |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy women age 18-45.
Key exclusion criteria (1 listed)
- pregnancy and vertigo
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 |
|---|---|---|
| weighted waist-hoopingweighted waist-hooping | Device | Weighted waist-hooping |
Primary outcome
Balance Error Scoring System (BESS)
Time frame: baseline
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.
Balance Error Scoring System (BESS)
Time frame: 6 - weeks
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.
Star Excursion Balance Test (SEBT)
Time frame: baseline
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.
Star Excursion Balance Test (SEBT)
Time frame: 6 - weeks
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.
equilibrium scores (EQ scores) of the Sensory Organization Test (SOT) on the NeuroCom
Time frame: baseline
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.
equilibrium scores (EQ scores) of the Sensory Organization Test (SOT) on the NeuroCom
Time frame: 6 - weeks
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.
Core Strength position 1
Time frame: baseline
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.
Core Strength position 1
Time frame: 6 - weeks
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.
Core Strength position 2
Time frame: baseline
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.
Core Strength position 2
Time frame: 6 - weeks
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.
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 9 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing weighted waist-hooping in people with Healthy, run by The Sage Colleges.
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 1 inclusion and 1 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 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Balance Error Scoring System (BESS) (time frame: baseline). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jan 2024.