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

NCT07747376 — Not applicable, Active not recruiting, 30 participants, Muhammad Hizami bin Mustafa

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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

Registry	NCT07747376
Status	Active not recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	30 (Actual)
Sponsor	Muhammad Hizami bin Mustafa (Other)
Conditions	Benign Paroxysmal Positional Vertigo (BPPV), Vestibular Hypofunction
Interventions	Home-based therapy, Standard Care (in control arm) (Other)
Dates	start 2026-05-04, primary completion 2026-11-01 (estimated), completion 2026-11-01 (estimated), first posted 2026-08-05, last updated 2026-08-05
Locations	1 site in Malaysia

-Summary

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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+Arms and interventions

Arm	Type	Interventions	Description
Intervention	Experimental	Other: Home-based therapy
Standard care	Active comparator	Other: Standard Care (in control arm)

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.

+Outcome measures

Primary outcomes

The Activities-specific Balance Confidence Scale [From enrollment to the end of treatment at 20 weeks]
Dizziness Handicap Inventory [From enrollment to the end of treatment at 20 weeks]
Dynamic Gait Index [From enrollment to the end of treatment at 20 weeks]
Timed Up and Go [From enrollment to the end of treatment at 20 weeks]
5 Times Sit To Stand [From enrollment to the end of treatment at 8 weeks]
EQ-5D-5L [From enrollment to the end of treatment at 8 weeks]

+Eligibility

Sex: All, ages: 60 Years to any

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

+Locations (1)

Facility	City	Country	Status
Hospital Pulau Pinang	George Town, Pulau Pinang	Malaysia

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