Clinical trial NCT04936022: Isometric Exercise for People With Raised Blood Pressure
Official title: Feasibility Study to Assess the Delivery of a Novel Isometric Exercise Intervention for People With Stage 1 Hypertension in the NHS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Isometric exercise
Exercise
Hypertension
High blood pressure
General practice
Feasibility study
Lead sponsor: East Kent Hospitals University NHS Foundation Trust
Sponsor class: OTHER_GOV
Collaborators: name: University of Kent
name: Canterbury Christ Church University
First posted: 2021-06-23
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multi-centre randomized controlled feasibility study
Primary purpose: OTHER

Brief summary: High blood pressure affects many people in the United Kingdom. People with raised blood pressure (140-159/90-99 mmHg) are recommended to make changes in their lifestyle (e.g. smoking/alcohol/diet/exercise) and/or medication in order to reduce their blood pressure. Current knowledge suggests that a particular type of exercise - isometric exercise - can lower blood pressure. Isometric exercise involves holding a fixed body position for a short period of time. As most of the information about the benefits of this type of exercise comes from laboratory-based studies, researchers want to find out if it is possible for GP practices to offer NHS patients with clinically high blood pressure an isometric exercise plan to do at home and how it might affect their blood pressure over 6 months. They will also find out the experiences of those doing this type of exercise and whether it can be done consistently at home over time.


Eligibility criteria: Inclusion Criteria:

* Aged 18 or over
* Clinic systolic BP 140-159 mmHg
* Able to provide informed consent

Exclusion Criteria:

* Currently taking anti-hypertensive medication
* White coat hypertension, as evidenced by averaged home systolic BP \<135 mmHg
* Inability to undertake study intervention (isometric exercise)
* Previous history of any of the following:

  * Diabetes mellitus (Type 1 or type 2)
  * Ischaemic heart disease (myocardial infarction and/or coronary angina and/or coronary revascularization procedure)
  * Moderate or severe stenotic or regurgitant heart valve disease
  * Atrial or ventricular arrhythmia
  * Stroke or transient ischaemic attack
  * Aortic aneurysm and/or peripheral arterial disease
  * Uncorrected congenital or inherited heart condition
* Estimated glomerular filtration rate \<45 ml/min (calculated using CKD-EPI or MDRD formulae, and taking most recent documented results)
* Documented left ventricular ejection fraction \<45% and/or left ventricular hypertrophy (by either echocardiography or standard ECG criteria e.g. Sokolow-Lyon)
* Documented urine albumin:creatinine ratio \>3.5 mg/mmol
* Inability to provide informed consent
* If female, pregnancy or currently breast feeding
* Enrolled in another Clinical Trial of an Interventional Medicinal Product or Medical Device or other interventional study
* Medical condition that, in the opinion of the investigator, would make the participant unsuitable for the study

Primary outcomes:
measure: Experience of intervention delivery
timeFrame: Project month 11
measure: Change in systolic blood pressure (mmHg) from baseline to Week 4.
timeFrame: Participant week 4
measure: Change in systolic blood pressure (mmHg) from baseline to Month 3.
timeFrame: Participant 3 months
measure: Change in systolic blood pressure (mmHg) from baseline to Month 6.
timeFrame: Participant 6 months
Secondary outcomes:
measure: Early fidelity of the isometric exercise prescription.
timeFrame: Participant week 1
measure: Short-term fidelity of the isometric exercise prescription.
timeFrame: Participant week 4
measure: Short-term adherence to the Isometric exercise (IE) training.
timeFrame: Participant week 4
measure: Mid-term adherence to the Isometric exercise training.
timeFrame: Participant 3 Months
measure: Long-term adherence to the Isometric exercise training.
timeFrame: Participant 6 Months
measure: Recruitment rates from data collected at sites.
timeFrame: Project month 10
measure: Short-term attrition rates from data collected at sites.
timeFrame: Participant week 4
measure: Mid-term attrition rates from data collected at sites.
timeFrame: Participant 3 months
measure: Long-term attrition rates from data collected at sites.
timeFrame: Participant 6 months
measure: Change in diastolic blood pressure (mmHg) from baseline to Week 4.
timeFrame: Week 4
measure: Change in diastolic blood pressure (mmHg) from baseline to Month 3.
timeFrame: Month 3
measure: Change in diastolic blood pressure (mmHg) from baseline to Month 6.
timeFrame: Month 6
measure: Experience of isometric exercise intervention.
timeFrame: Month 11
measure: Participant experiences of undertaking isometric exercise.
timeFrame: Participant week 4.
measure: Subjective opinion of healthcare professionals on their willingness to consider the intervention as a treatment option for patients with Stage 1 hypertension.
timeFrame: Project month 11.
measure: Short-term Quality-adjusted life years (QALYs) calculated from patients' responses to the EQ-5D-5L questionnaire.
timeFrame: Participant 4 weeks
measure: Mid-term Quality-adjusted life years calculated from patients' responses to the EQ-5D-5L questionnaire.
timeFrame: Participant 3 months
measure: Long-term Quality-adjusted life years calculated from patients' responses to the EQ-5D-5L questionnaire.
timeFrame: Participant 6 months
measure: Healthcare resource utilisation (a).
timeFrame: Participant 4 weeks.
measure: Healthcare resource utilisation (a).
timeFrame: Participant 3 months
measure: Healthcare resource utilisation (a).
timeFrame: Participant 6 months
measure: Healthcare resource utilisation (b).
timeFrame: Participant 4 weeks.
measure: Healthcare resource utilisation (b).
timeFrame: Participant 3 months.
measure: Healthcare resource utilisation (b).
timeFrame: Participant 6 months.
measure: Healthcare resource utilisation (c).
timeFrame: Participant 4 weeks.
measure: Healthcare resource utilisation (c).
timeFrame: Participant 3 months.
measure: Healthcare resource utilisation (c).
timeFrame: Participant 6 months.
measure: Healthcare resource utilisation (d).
timeFrame: Participant 4 weeks.
measure: Healthcare resource utilisation (d).
timeFrame: Participant 3 months.
measure: Healthcare resource utilisation (d).
timeFrame: Participant 6 months.
measure: Healthcare resource utilisation (e).
timeFrame: Participant 4 weeks.
measure: Healthcare resource utilisation (e).
timeFrame: Participant 3 months.
measure: Healthcare resource utilisation (e).
timeFrame: Participant 6 months.
measure: Healthcare resource utilisation (f).
timeFrame: Participant 4 weeks.
measure: Healthcare resource utilisation (f).
timeFrame: Participant 3 months.
measure: Healthcare resource utilisation (f).
timeFrame: Participant 6 months.
measure: Intervention costs.
timeFrame: Participant 4 weeks.
measure: Intervention costs.
timeFrame: Participant 3 months.
measure: Intervention costs
timeFrame: Participant 6 months.
measure: Medication at short-term time point (a)
timeFrame: Participant 4 weeks.
measure: Medication at mid-term time point (a)
timeFrame: Participant 3 months.
measure: Medication at long-term time point (a)
timeFrame: Participant 6 months.
measure: Medication at short-term time point (b)
timeFrame: Participant 4 weeks.
measure: Medication at mid-term time point (b)
timeFrame: Participant 3 months.
measure: Medication at long-term time point (b)
timeFrame: Participant 6 months.
Other outcomes:
Locations:
city: Canterbury
country: United Kingdom
facility: Canterbury Medical Practice
state: Kent
city: Canterbury
country: United Kingdom
facility: Kent and Canterbury Hospital
state: Kent
city: Faversham
country: United Kingdom
facility: Newton Place Surgery
state: Kent
city: Carshalton
country: United Kingdom
facility: St Helier Hospital
state: Surrey
city: Bognor Regis
country: United Kingdom
facility: Maywood Healthcare Centre
state: West Sussex
city: Hove
country: United Kingdom
facility: Brighton Health and Wellbeing Centre
Study officials:
affiliation: University of Kent
name: Christopher K Farmer
role: STUDY_DIRECTOR
References: