Balance ChangesNCT03161236
Assessing Balance Changes Following an Exercise Program Among Middle-Aged Adults
A study testing home exercise program and non exercise program in people with Balance Changes, run by Loma Linda University at 1 site in United States.
Trial summary
This graduate student research study has two purposes; the first purpose is to examine the criterion validity of the Y Balance Test (YBT) with the Limits of Stability Test (LOS) in healthy middle-aged adults. The second purpose is to examine balance changes using the YBT following a home-based exercise program. Read more about this study
- Who is it for?
- Ages 45 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Balance Changes
- What is being tested?
- home exercise program and non exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2016to 1 Jun 2019
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age range: 45-64 years.
- Able to walk and move independently
- Exclusion Criteria:• Dizziness, visual or neurological disorders that prevent the ability to complete the testing protocol.
- Lower limb injury in the last 3 months.
- Lower limb surgery in the last 6 months.
- Current involvement in a rehabilitation program.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
This graduate student research study has two purposes; the first purpose is to examine the criterion validity of the Y Balance Test (YBT) with the Limits of Stability Test (LOS) in healthy middle-aged adults. The second purpose is to examine balance changes using the YBT following a home-based exercise program.
Read the detailed description
- "Subjects will be healthy female or male middle-aged adults who are able to walk and move independently.
- "Subjects will be between 45 and 64 years of age." 6. "In total, subject participation will last approximately eight weeks. Visit 1 (baseline): 90 minutes, visit 2 (week 4): 30 minutes, and visit 3 (week 8): 60 minutes.
- "Subjects will be recruited by distributing flyers in the Loma Linda Community, sending emails to school staff, students, and faculty, and word of mouth.
- "Consent will take place at Loma Linda University, Nichol Hall rooms A620 -A640 by investigators." 9. If Multi-center: N/A 10. If Single center or investigator-initiated: "70 subjects will participate in the study."
- Conditions
- Balance Changes
- Being tested
- home exercise program, non exercise program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
home exercise programOther
Subjects in the exercise group will be instructed to follow the intervention protocol for eight weeks. The intervention consists of five exercises: standing on one foot, walking heel to toe, heel walking, side kicks, and wall squats. Each exercise will be repeated three times per week for eight weeks.
non exercise programOther
continue usual lifestyle
| Study group | Role | What they receive |
|---|---|---|
| home exercise program | Experimental | • The exercise group will follow a home exercise protocol for eight weeks: that involves standing on one foot, walking, and doing wall squats. Receives: Other: home exercise program |
| non exercise group | Active comparator | • The non-exercise group will continue with their usual life style Receives: Other: non exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Y Balance Test
The test assesses performance during single-leg balance with a reaching task in the anterior (ANT), posteromedial (PM), and posterolateral (PL) directions to determine lower extremity movement asymmetry and balance deficits. ANT, PM, and PL are a composite measurement.
Measured: change from baseline to 4 weeks
Y Balance Test
The test assesses performance during single-leg balance with a reaching task in the anterior (ANT), posteromedial (PM), and posterolateral (PL) directions to determine lower extremity movement asymmetry and balance deficits. ANT, PM, and PL are a composite measurement.
Measured: change from 4 weeks to 8 weeks
Secondary outcomes (2)
limits of stability
Limits of Stability measure five parameters: reaction time (RT), movement velocity (MVL), endpoint excursion (EPE), maximum excursion (MXE), and directional control (DC). RT, MVL, EPE, MXE, and DC are composite measures.
Measured: change from baseline to 4 weeks
limits of stability
Limits of Stability measure five parameters: reaction time (RT), movement velocity (MVL), endpoint excursion (EPE), maximum excursion (MXE), and directional control (DC). RT, MVL, EPE, MXE, and DC are composite measures.
Measured: change from 4 weeks to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study start31 Oct 2016
- Primary completion1 Jun 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Balance ChangesStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gurinder Bains, Loma Linda University
- Investigators
- Gurinder Bains, PhD, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03161236
- Sponsor's protocol ID
- 5160196
- Status last verified
- Jul 2019
- First submitted
- 15 Mar 2017
- Last updated
- 10 Jul 2019
- 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 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Balance Changes Following an Exercise Program Among Middle-Aged Adults
- ClinicalTrials.gov ID
- NCT03161236
- Acronym / sponsor ID
- 5160196
- Conditions
- Balance Changes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 31 Oct 2016 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 19 May 2017 (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.
This graduate student research study has two purposes; the first purpose is to examine the criterion validity of the Y Balance Test (YBT) with the Limits of Stability Test (LOS) in healthy middle-aged adults. The second purpose is to examine balance changes using the YBT following a home-based exercise program.
Detailed description
- "Subjects will be healthy female or male middle-aged adults who are able to walk and move independently.
- "Subjects will be between 45 and 64 years of age." 6. "In total, subject participation will last approximately eight weeks. Visit 1 (baseline): 90 minutes, visit 2 (week 4): 30 minutes, and visit 3 (week 8): 60 minutes.
- "Subjects will be recruited by distributing flyers in the Loma Linda Community, sending emails to school staff, students, and faculty, and word of mouth.
- "Consent will take place at Loma Linda University, Nichol Hall rooms A620 -A640 by investigators." 9. If Multi-center: N/A 10. If Single center or investigator-initiated: "70 subjects will participate in the study."
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| home exercise program | Experimental | Other: home exercise program• The exercise group will follow a home exercise protocol for eight weeks: that involves standing on one foot, walking, and doing wall squats. |
| non exercise group | Active comparator | Other: non exercise program• The non-exercise group will continue with their usual life style |
Who may qualify
- Ages
- 45 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age range: 45-64 years.
- Able to walk and move independently
- Exclusion Criteria:• Dizziness, visual or neurological disorders that prevent the ability to complete the testing protocol.
- Lower limb injury in the last 3 months.
- Lower limb surgery in the last 6 months.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| home exercise programSubjects in the exercise group will be instructed to follow the intervention protocol for eight weeks. The intervention consists of five exercises: standing on one foot, walking heel to toe, heel walking, side kicks, and wall squats. Each exercise will be repeated three times per week for eight weeks. | Other | home exercise program |
| non exercise programcontinue usual lifestyle | Other | non exercise group |
Primary outcome
Y Balance Test
Time frame: change from baseline to 4 weeks
The test assesses performance during single-leg balance with a reaching task in the anterior (ANT), posteromedial (PM), and posterolateral (PL) directions to determine lower extremity movement asymmetry and balance deficits. ANT, PM, and PL are a composite measurement.
Y Balance Test
Time frame: change from 4 weeks to 8 weeks
The test assesses performance during single-leg balance with a reaching task in the anterior (ANT), posteromedial (PM), and posterolateral (PL) directions to determine lower extremity movement asymmetry and balance deficits. ANT, PM, and PL are a composite measurement.
2 secondary outcomes
limits of stability
Time frame: change from baseline to 4 weeks
limits of stability
Time frame: change from 4 weeks to 8 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 10 Jul 2019.
- Individual participant dataSharing planned: No
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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.
Gurinder Bains, PhD principal investigator
Loma Linda 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 home exercise program and non exercise program in people with Balance Changes, run by Loma Linda 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 6 inclusion and 0 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 10 Jul 2019. 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. 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?
Y Balance Test (time frame: change from baseline to 4 weeks). The study lists 2 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 10 Jul 2019.