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The Effectiveness Of Home-Based Circuit Training On Eye Pressure And Eye Nerve Structures In Patients With Glaucoma

29. juli 2026 oppdatert av: Tharani Elumalai, Universiti Sains Malaysia

The Effectiveness Of Home-Based Circuit Training On Intraocular Pressure, Retinal Nerve Fiber Layers And Choroidal Thickness In Patients With Glaucoma

The goal of this randomised control trial is to learn about the effect of home based circuit training on patients with primary glaucoma.

The main questions to answer are:

  1. Is there any difference of intraocular pressure (IOP) in patient with primary glaucoma after 6 weeks and 12 weeks who is performing home-based circuit training compared to patient not performing home-based circuit training?
  2. Is there any difference of retina nerve fibre layer in patient with primary glaucoma after 6 weeks and 12 weeks who is performing home-based circuit training compared to patient not performing home-based circuit training?
  3. Is there any difference of choroidal thickness layer in patient with primary glaucoma after 6 weeks and 12 weeks who is performing home-based circuit training compared to patient not performing home-based circuit training?

Researchers will compare patients with primary glaucoma who are performing home-based circuit training and not performing home-based circuit training to see if any affect to intraocular pressure, retina nerve fibre layer and choroidal thickness.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Glaucoma is the leading cause of irreversible blindness worldwide. According to a study, it is known that East Asia has the highest number of people with glaucoma (25.20 million), followed by South- Central Asia (17.06 million) and South East Asia (6.92 million). The global prevalence of glaucoma especially in people aged 40 to 80 years is estimated to be 3.5%. The most important risk factor for glaucoma is aging. With the growing number and proportion of older population, it is projected that 111.8 million people will have glaucoma in 2040. The degeneration of retinal ganglion cells (RGCs) and their axons result in an irreversible loss of vision that has a strong correlation with increasing age. The relationship between exercise and glaucoma is complex as various components of physical activity such as fluctuations in blood pressure, body posture, and Valsalva manoeuvres can influence intraocular pressure (IOP) and ocular perfusion pressure, both of which may play roles in glaucoma pathophysiology.

The investigator would like to evaluate the effect of 12 weeks home-based circuit training on intraocular pressure (IOP), retinal nerve fibre layer thickness (RNFL) and choroidal thickness in patients with primary glaucoma. This is a randomised controlled study involving primary glaucoma patients who are attending ophthalmology clinic at Hospital Universiti Sains Malaysia. Evaluation of study sample includes baseline ocular examination, IOP and Optical Coherence Tomography Retinal Nerve Fibre Layer (OCT RNFL) and sub foveal choroidal thickness. Subjects who fulfil the inclusion and exclusion criteria for the study will be selected.

Patients in Group A will perform home-based circuit training for 12 weeks while other Group B (control group) will not perform home-based circuit training. IOP, OCT RNFL and choroidal thickness measurement will be taken at baseline, 6 weeks and 12 weeks post recruitment of subjects. All patients will be given exercise diary to note down their exercise adherence.

Studietype

Intervensjonell

Registrering (Antatt)

60

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Malaysia
    • Kelantan
      • Kubang Kerian, Kelantan, Malaysia, 16150

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • Age ≥ 18 - 70 years old
  • Known case of POAG, PACG, JOAG, NTG
  • Phakic without visually significant cataract
  • Pseudophakic for more than 3 months prior to recruitment
  • Achieved target IOP
  • Physically not performing routine exercises

Exclusion Criteria:

  • Bilateral eye visual acuity of less than 6/60
  • Bilateral eye visual field defect of less than 10 degrees from fixation
  • Patient with media opacities that affect the reliability of OCT measurements such as cornea opacity, dense cataract with Lens opacification classification system (LOCS III) of more than grade 2, vitreous haemorrhage
  • Patient who underwent intraocular surgery (other than uncomplicated cataract surgery), including anti-vascular endothelial growth factor injection within past 6 months
  • Ocular disease such as cornea ulcer, uveitis, age-related macula degeneration
  • Physical disabilities such as stroke, limbs amputation
  • Uncontrolled systemic diseases eg diabetes, hypertension
  • Morbid Obesity (BMI > 40)
  • Dementia or any psychiatric diseases
  • Smoking

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Home-Based Circuit Training
Patients in Group A will be performing home-based circuit training three times per week for 12 weeks.
Atferdsmessig: Home-Based Circuit Training
Participants assigned to the intervention group will perform a home-based circuit training program in addition to receiving standard glaucoma care. The exercise program consists of seven home-based exercises, including two aerobic exercises and five resistance-based exercises performed in a circuit format. Each session will last 30 minutes for week 1-6 and 60 minutes for week 7-12. It is performed three times per week on alternate days for 12 weeks, and is conducted at moderate intensity. Participants will continue their prescribed glaucoma medications throughout the study.
Ingen inngripen: Control Group
Patients in Group B will not will be performing

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Intraocular pressure
Tidsramme: Baseline, at 6 weeks and at 12 weeks
Baseline, at 6 weeks and at 12 weeks
Retinal Nerve Fiber Layer
Tidsramme: Baseline, at 6 weeks and at 12 weeks
Baseline, at 6 weeks and at 12 weeks
Choroidal Thickness
Tidsramme: Baseline, at 6 weeks and at 12 weeks
Baseline, at 6 weeks and at 12 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Universiti Sains Malaysia

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. august 2026

Primær fullføring (Antatt)

1. august 2027

Studiet fullført (Antatt)

1. desember 2027

Datoer for studieregistrering

Først innsendt

24. juli 2026

Først innsendt som oppfylte QC-kriteriene

24. juli 2026

Først lagt ut (Faktiske)

29. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

30. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • HBCT-GLAU-2026-01

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Individual participant data (IPD) will not be shared because participant confidentiality and privacy will be protected in accordance with institutional ethics requirements and informed consent. Only aggregate study results will be published.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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