NCT04133857

Brief Summary

Purpose to study the acute effects of both forms of aerobic exercise (HIIT and SSMIT) on intraocular pressure among healthy sedentary individuals

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2018

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2018

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

October 11, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 21, 2019

Completed
Last Updated

October 21, 2019

Status Verified

October 1, 2019

Enrollment Period

1 month

First QC Date

October 11, 2019

Last Update Submit

October 17, 2019

Conditions

Intraocular Pressure

Outcome Measures

Primary Outcomes (1)

  • Changes in intraocular pressure

    changes in intraocular pressure before and after exervcise

    30 minutes

Secondary Outcomes (1)

  • compare which form of exercise (HIIT & SSMIT) is superior in reducing intraocular pressure

    30 days

Study Arms (2)

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

aerobic exerciseOTHER

aerobic exercise HIIT : High intensity interval training SSMIT : Steady state moderate intensity training

Group AGroup B

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • all University hospital staff

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Malaya

Kuala Lumpur, Wilayah Perseketuan, 59100, Malaysia

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

October 11, 2019

First Posted

October 21, 2019

Study Start

January 1, 2018

Primary Completion

January 31, 2018

Study Completion

February 28, 2018

Last Updated

October 21, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

MY(1)