Intraocular PressureNCT04133857
Acute Effects of HIIT and SSMIT on Intraocular Pressure Among Sedentary Individuals
A study testing aerobic exercise in people with Intraocular Pressure, run by University of Malaya at 1 site in Malaysia.
Trial summary
Purpose to study the acute effects of both forms of aerobic exercise (HIIT and SSMIT) on intraocular pressure among healthy sedentary individuals Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Intraocular Pressure
- What is being tested?
- aerobic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Jan 2018to 28 Feb 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 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- all University hospital staff
Who cannot join
- previous ocular trauma
- surgery in the eligible eye
- known case of glaucoma or glaucoma suspect (IOP > 21mmHg)
- history of glaucoma laser procedure/surgery within 6 months in eligible eye
- unable to undergo IOP measurements
- undiagnosed visual condition
- any uncontrolled medical condition such as end stage renal failure, uncontrolled diabetes and uncontrolled hypertension
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Effects of High Intensity Interval Training (HIIT) and Steady State Moderate Intensity Training (SSMIT) on Intraocular Pressure Among Sedentary Individuals
Purpose to study the acute effects of both forms of aerobic exercise (HIIT and SSMIT) on intraocular pressure among healthy sedentary individuals
Read the detailed description
40 participants were recruited and divided into 2 groups. Each group performed 2 exercise protocols with a 4 day washout period between them.
The intraocular pressure was measured before the exercise and after the exercise in 5 minute periods up until 30 minutes post exercise.
The intraocular pressure was measured using a handheld rebound tonometer.
- Conditions
- Intraocular Pressure
- Being tested
- aerobic exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic exerciseOther
aerobic exercise HIIT : High intensity interval training SSMIT : Steady state moderate intensity training
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | undergo HIIT first then SSMIT protocol Receives: Other: aerobic exercise |
| Group B | Active comparator | undergo SSMIT first then HIIT protocol Receives: Other: aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in intraocular pressure
changes in intraocular pressure before and after exervcise
Measured: 30 minutes
Secondary outcomes (1)
compare which form of exercise (HIIT & SSMIT) is superior in reducing intraocular pressure
difference in intraocular pressure reduction observed between each exercise protocol
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2019
- Study start1 Jan 2018
- Primary completion31 Jan 2018
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraocular PressureStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Mohd Nahar Azmi Mohamed, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04133857
- Sponsor's protocol ID
- 20171031-5738
- Status last verified
- Oct 2019
- First submitted
- 11 Oct 2019
- Last updated
- 21 Oct 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 21 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of High Intensity Interval Training (HIIT) and Steady State Moderate Intensity Training (SSMIT) on Intraocular Pressure Among Sedentary Individuals
- ClinicalTrials.gov ID
- NCT04133857
- Acronym / sponsor ID
- 20171031-5738
- Conditions
- Intraocular Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 21 Oct 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.
Purpose to study the acute effects of both forms of aerobic exercise (HIIT and SSMIT) on intraocular pressure among healthy sedentary individuals
Detailed description
40 participants were recruited and divided into 2 groups. Each group performed 2 exercise protocols with a 4 day washout period between them.
The intraocular pressure was measured before the exercise and after the exercise in 5 minute periods up until 30 minutes post exercise.
The intraocular pressure was measured using a handheld rebound tonometer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Other: aerobic exerciseundergo HIIT first then SSMIT protocol |
| Group B | Active comparator | Other: aerobic exerciseundergo SSMIT first then HIIT protocol |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- all University hospital staff
Key exclusion criteria (7 listed)
- previous ocular trauma
- surgery in the eligible eye
- known case of glaucoma or glaucoma suspect (IOP > 21mmHg)
- history of glaucoma laser procedure/surgery within 6 months in eligible eye
- unable to undergo IOP measurements
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 |
|---|---|---|
| aerobic exerciseaerobic exercise HIIT : High intensity interval training SSMIT : Steady state moderate intensity training | Other | Group A, Group B |
Primary outcome
Changes in intraocular pressure
Time frame: 30 minutes
changes in intraocular pressure before and after exervcise
1 secondary outcome
compare which form of exercise (HIIT & SSMIT) is superior in reducing intraocular pressure
Time frame: 30 days
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 21 Oct 2019.
- Individual participant dataSharing planned: No
Related trials for Intraocular Pressure
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Automated Applanation Tonometry - Updated
Glaucoma, Glaucoma, Suspect
RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Not yet recruiting
Glaucoma Drop Aids Part 2
Glaucoma, Intraocular Pressure
Not yet recruitingPhase 4
Iopidine to Decrease Intraocular Pressure Rise After Injections
Macular Degeneration, Diabetic Retinopathy
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aerobic exercise in people with Intraocular Pressure, run by University of Malaya at 1 site in Malaysia.
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 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 21 Oct 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 Malaysia. 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?
Changes in intraocular pressure (time frame: 30 minutes). 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 21 Oct 2019.