Acute Effects of HIIT and SSMIT on Intraocular Pressure A... | NCT04133857

Studies
Acute Effects of HIIT and SSMIT on Intraocular Pressure Among Sedentary Individuals

NCT04133857

Sponsor

University of Malaya

Status

Completed

Last Update Posted

Oct 21, 2019Actual

Enrollment

40Actual

Phase

Not Applicable

Conditions

Intraocular Pressure

Interventions

aerobic exercise

Countries

Malaysia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2018Actual

Primary Completion Date

Jan 31, 2018Actual

Completion Date

Feb 28, 2018Actual

First Submitted Date

Oct 11, 2019

First Submission Date that Met QC Criteria

Oct 17, 2019

First Posted Date

Oct 21, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 17, 2019

Last Update Posted Date

Oct 21, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	Active Comparator	undergo HIIT first then SSMIT protocol	Other: aerobic exercise
Group B	Active Comparator	undergo SSMIT first then HIIT protocol	Other: aerobic exercise

Interventions

Name	Type	Description	Arm Group Labels	Other Names
aerobic exercise	Other	aerobic exercise HIIT : High intensity interval training SSMIT : Steady state moderate intensity training	Group A Group B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in intraocular pressure	changes in intraocular pressure before and after exervcise	30 minutes

Secondary Outcomes

Measure	Description	Time Frame
compare which form of exercise (HIIT & SSMIT) is superior in reducing intraocular pressure	difference in intraocular pressure reduction observed between each exercise protocol	30 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all University hospital staff

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Malaya		Kuala Lumpur	Wilayah Perseketuan	59100	Malaysia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Oct 15, 2019	Oct 17, 2019	Prot_SAP_000.pdf

Intervention Browse Module

MeSH Terms

ID	Term
D015444	Exercise

Ancestor Terms

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided