Evaluating the feasibility and acceptability of home-based isometric exercise and behaviour change for the management of hypertension: The HOME-FIT study protocol.

The HOME-FIT study is designed as a pilot randomised controlled trial evaluating a 24-week remotely delivered home-based isometric exercise and behaviour change intervention for adults with arterial hypertension.

• Arterial hypertension is defined as ≥140/90 mmHg per European and UK guidelines.
• The study will recruit 70 participants diagnosed with AH and receiving pharmacological treatment from Newcastle upon Tyne, United Kingdom.
• Participants will be randomised with minimisation for sex and mean office systolic BP (≤140 mmHg vs >140 mmHg).
• The intervention group (n=35) and control group (n=35) will be followed for 24 weeks total.
• The study is registered at ClinicalTrials.gov (NCT07213479).

The intervention consists of 12 weeks of remotely supervised isometric wall squat exercises performed three times per week, followed by a 12-week maintenance phase.

• The exercise component involves isometric wall squat exercises delivered remotely.
• Exercise sessions occur three times per week during the initial 12-week supervised phase.
• After the initial 12 weeks, participants are followed for an additional 12 weeks and continue to receive guidance to maintain the wall squat exercise.
• Exercise adherence will be measured by the proportion of sessions completed.

The intervention group will also receive behaviour change advice based on a leaflet following UK recommendations covering multiple lifestyle factors.

• Behaviour change advice covers weight management, diet, physical activity, salt intake, alcohol reduction, and smoking cessation.
• Behaviour change adherence will be self-reported via a questionnaire assessed at 12 and 24 weeks.
• The control group will receive similar behaviour change advice reinforcing standard care recommendations.
• After 12 weeks, the intervention group will continue to receive further guidance to maintain behaviour changes.

Primary feasibility outcomes will be determined by screening, eligibility, recruitment, and retention rates at 12 and 24 weeks.

• Primary outcomes for feasibility include screening rate, eligibility rate, recruitment rate, and retention rate.
• Retention rates will be assessed at both 12 and 24 weeks.
• Exercise adherence is measured by proportion of sessions completed.
• Participant acceptability will be determined through semi-structured interviews.

Secondary outcomes include office and ambulatory blood pressure measurements assessed at three time points.

• Secondary outcomes include both office and ambulatory BP measurements.
• Measurements will be taken at baseline, 12 weeks, and 24 weeks.
• The study will 'explore the potential effects of the intervention on office and ambulatory blood pressure (BP).'
• As a pilot trial, the study is not powered to detect statistically significant differences in BP outcomes.

The findings from this pilot study are intended to guide the development of a future large-scale trial evaluating effectiveness and cost-effectiveness of non-pharmacological hypertension management.

• The study aims to address 'key gaps and supporting scalable, patient-centred care.'
• The future trial would evaluate both effectiveness and cost-effectiveness.
• The intervention is designed to be non-pharmacological, complementing existing pharmacological treatment.
• All 70 participants are already receiving pharmacological treatment for hypertension at the time of enrolment.