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NCT Number: NCT07747376

Benign Paroxysmal Positional Vertigo With and Without Vestibular Hypofunction: Protocol for an Integrated Home-Based Exercise With Self-Managed Education Programme

The goal of this feasibility pilot randomised controlled trial is to determine whether a home-based exercise programme integrated with a self-managed education programme is feasible, acceptable, and safe for adults aged 60 years and older with benign paroxysmal positional vertigo (BPPV) with and without vestibular hypofunction. The study will also evaluate whether the trial procedures are suitable for a future definitive randomised controlled trial.

The main questions it aims to answer are:

Can participants follow the programme as planned? Can participants be retained throughout the 20-week study? Is the programme acceptable to participants? Do participants experience any adverse events? Do the clinical outcomes show preliminary changes that support further investigation?

Researchers will randomly assign participants to receive either the home-based exercise and self-managed education programme or standard care alone. Preliminary changes in dizziness, balance confidence, gait performance, fall risk, physical activity, and health-related quality of life will be explored. As this is a feasibility pilot study, it is not designed to provide definitive evidence of effectiveness.

Participants will:

Take part in the study for 20 weeks Follow their assigned intervention or standard care as instructed Complete assessments at baseline, week 10, and week 20 Report their adherence, experience with the programme, and any adverse events during the study

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Benign Paroxysmal Positional Vertigo (BPPV) Benign Paroxysmal Positional Vertigo Ear Diseases Labyrinth Diseases Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Vertigo Vestibular Diseases Vestibular Hypofunction

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Pulau Pinang

George Town, Pulau Pinang, 10990, Malaysia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed as benign paroxysmal positional vertigo by an otolaryngologist or Medical Doctor at the Ear, Nose, and Throat Clinic Hospital Pulau Pinang
  • Aged 60 years and older
  • Do not receive treatment from outside Hospital Pulau Pinang

Exclusion criteria

  • Severe neurological conditions, including stroke or peripheral neuropathy
  • Severe musculoskeletal disorders such as fractures, rheumatoid arthritis, or recent injuries that limit movement
  • • Clinically diagnosed hearing or visual impairments

Treatment and study plan

Home-based therapy

Other

The intervention combines structured, progressive home-based exercises with a self-managed education resource. The exercises are based on vestibular rehabilitation principles and target movement-related dizziness, gaze stability, postural balance, gait, and functional mobility. Participants receive an illustrated booklet containing step-by-step exercise instructions, guidance on gradual progression and rest periods, and safety precautions. Exercise progression is adapted according to the participant's functional ability and symptom response. The education component addresses understanding of BPPV and vestibular hypofunction, safe exercise performance, symptom self-management, adherence, and when to seek professional advice. Participants are instructed to discontinue an exercise and obtain appropriate clinical advice if severe or worsening symptoms occur.

Standard Care (in control arm)

Other

Standard care consists of routine clinical management for BPPV with and without vestibular hypofunction provided at the study site. Treatment includes a canalith repositioning manoeuvre selected according to the affected semicircular canal and side, together with routine clinical advice and follow-up. Any additional management is determined by the treating clinician according to the participant's clinical needs and usual practice at the study site.

Primary outcomes

  1. The Activities-specific Balance Confidence Scale

    Time frame: From enrollment to the end of treatment at 20 weeks

  2. Dizziness Handicap Inventory

    Time frame: From enrollment to the end of treatment at 20 weeks

  3. Dynamic Gait Index

    Time frame: From enrollment to the end of treatment at 20 weeks

  4. Timed Up and Go

    Time frame: From enrollment to the end of treatment at 20 weeks

  5. 5 Times Sit To Stand

    Time frame: From enrollment to the end of treatment at 8 weeks

  6. EQ-5D-5L

    Time frame: From enrollment to the end of treatment at 8 weeks

Sponsors and collaborators

Lead sponsor

Muhammad Hizami bin Mustafa

Other

Registry information

Official study title

Development and Validation of a Home-based Exercise Programme Integrated With a Self-managed Education Programme in People With Benign Paroxysmal Positional Vertigo With and Without Vestibular Hypofunction

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 5, 2026
Registry last updated
Aug 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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