Isometric Exercise for People With Raised Blood Pressure

Hypertension Clinical Trial

— IsoFIT-BP  

Official title:

Feasibility Study to Assess the Delivery of a Novel Isometric Exercise Intervention for People With Stage 1 Hypertension in the NHS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04936022
• Other study ID #: NIHR200485
• Secondary ID: 13472393
• Status: Completed
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: November 30, 2022

Study information

• Verified date: September 2023
• Source: East Kent Hospitals University NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Other:
• Isometric Exercise
Prescribed 6 months of isometric exercise training (three sessions per week, comprised of 4 x 2-minute bouts with 2-minute recovery periods in-between).

Behavioral:
• Standard care lifestyle advice
Healthy lifestyle advice for hypertension, given by a healthcare professional.

Locations

Country	Name	City	State
United Kingdom	Maywood Healthcare Centre	Bognor Regis	West Sussex
United Kingdom	Canterbury Medical Practice	Canterbury	Kent
United Kingdom	Kent and Canterbury Hospital	Canterbury	Kent
United Kingdom	St Helier Hospital	Carshalton	Surrey
United Kingdom	Newton Place Surgery	Faversham	Kent
United Kingdom	Brighton Health and Wellbeing Centre	Hove

Sponsors (3)

Lead Sponsor	Collaborator
East Kent Hospitals University NHS Foundation Trust	Canterbury Christ Church University, University of Kent

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Experience of intervention delivery	Qualitative focus groups with health care professionals identifying the type and number of each barrier and facilitator, of the practical delivery of isometric exercise intervention.	Project month 11
Primary	Change in systolic blood pressure (mmHg) from baseline to Week 4.		Participant week 4
Primary	Change in systolic blood pressure (mmHg) from baseline to Month 3.		Participant 3 months
Primary	Change in systolic blood pressure (mmHg) from baseline to Month 6.		Participant 6 months
Secondary	Early fidelity of the isometric exercise prescription.	Assessed by checking whether individual participant's heart rate (bpm) measures fall within 95% of their peak heart rate confidence intervals following the first three training sessions.	Participant week 1
Secondary	Short-term fidelity of the isometric exercise prescription.	Assessed by checking whether individual participant's heart rate (bpm) measures fall within 95% of their peak heart rate confidence intervals following the first four weeks (12) of training sessions.	Participant week 4
Secondary	Short-term adherence to the Isometric exercise (IE) training.	Measured using the proportion of participants (number) completing a minimum of 8 of 12 IE sessions up to the 4-week point.	Participant week 4
Secondary	Mid-term adherence to the Isometric exercise training.	Measured using the proportion of participants (number) completing a minimum of two thirds of all IE sessions up to 3 months.	Participant 3 Months
Secondary	Long-term adherence to the Isometric exercise training.	Measured using the proportion of participants (number) completing a minimum of two thirds of all IE sessions up to 6 months.	Participant 6 Months
Secondary	Recruitment rates from data collected at sites.	This will be measured by calculating the average number of participants recruited per week.	Project month 10
Secondary	Short-term attrition rates from data collected at sites.	This will be measured by calculating the number of withdrawals from the study up to 4 weeks.	Participant week 4
Secondary	Mid-term attrition rates from data collected at sites.	This will be measured by calculating the number of withdrawals from the study up to 3 months.	Participant 3 months
Secondary	Long-term attrition rates from data collected at sites.	This will be measured by calculating the number of withdrawals from the study up to 6 months.	Participant 6 months
Secondary	Change in diastolic blood pressure (mmHg) from baseline to Week 4.		Week 4
Secondary	Change in diastolic blood pressure (mmHg) from baseline to Month 3.		Month 3
Secondary	Change in diastolic blood pressure (mmHg) from baseline to Month 6.		Month 6
Secondary	Experience of isometric exercise intervention.	Qualitative focus groups with study participants identifying the number of positive and negative experiences of the isometric exercise intervention and taking part in the study.	Month 11
Secondary	Participant experiences of undertaking isometric exercise.	Collected using participant study-specific survey with closed and open questions.	Participant week 4.
Secondary	Subjective opinion of healthcare professionals on their willingness to consider the intervention as a treatment option for patients with Stage 1 hypertension.	Collected using semi-structured interviews conducted by telephone with healthcare professionals from GP practices not taking part as study recruitment sites.	Project month 11.
Secondary	Short-term Quality-adjusted life years (QALYs) calculated from patients' responses to the EQ-5D-5L questionnaire.	The health profile established from EQ-5D-5L will be converted into a utility index (0 and 1) using the validated mapping function to derive utility values for EQ-5D-5L from the existing EQ-5D-3L. These utilities will be multiplied by the time spent in each state to generate QALYs.	Participant 4 weeks
Secondary	Mid-term Quality-adjusted life years calculated from patients' responses to the EQ-5D-5L questionnaire.	The health profile established from EQ-5D-5L will be converted into a utility index (0 and 1) using the validated mapping function to derive utility values for EQ-5D-5L from the existing EQ-5D-3L. These utilities will be multiplied by the time spent in each state to generate QALYs.	Participant 3 months
Secondary	Long-term Quality-adjusted life years calculated from patients' responses to the EQ-5D-5L questionnaire.	The health profile established from EQ-5D-5L will be converted into a utility index (0 and 1) using the validated mapping function to derive utility values for EQ-5D-5L from the existing EQ-5D-3L. These utilities will be multiplied by the time spent in each state to generate QALYs.	Participant 6 months
Secondary	Healthcare resource utilisation (a).	Measuring healthcare access by using the number of GP visits at 4 weeks.	Participant 4 weeks.
Secondary	Healthcare resource utilisation (a).	Measuring healthcare access by using the number of GP visits at 3 months.	Participant 3 months
Secondary	Healthcare resource utilisation (a).	Measuring healthcare access by using the number of GP visits at 6 months.	Participant 6 months
Secondary	Healthcare resource utilisation (b).	Measuring healthcare access by using the number of nurse visits at 4 weeks.	Participant 4 weeks.
Secondary	Healthcare resource utilisation (b).	Measuring healthcare access by using the number of nurse visits at 3 months.	Participant 3 months.
Secondary	Healthcare resource utilisation (b).	Measuring healthcare access by using the number of nurse visits at 6 months.	Participant 6 months.
Secondary	Healthcare resource utilisation (c).	Measuring healthcare access by using the number of other health professionals visits at 4 weeks.	Participant 4 weeks.
Secondary	Healthcare resource utilisation (c).	Measuring healthcare access by using the number of other health professionals visits at 3 months.	Participant 3 months.
Secondary	Healthcare resource utilisation (c).	Measuring healthcare access by using the number of other health professionals visits at 6 months.	Participant 6 months.
Secondary	Healthcare resource utilisation (d).	Measuring healthcare access by using the number of number of A&E attendances at 4 weeks.	Participant 4 weeks.
Secondary	Healthcare resource utilisation (d).	Measuring healthcare access by using the number of number of A&E attendances at 3 months.	Participant 3 months.
Secondary	Healthcare resource utilisation (d).	Measuring healthcare access by using the number of number of A&E attendances at 6 months.	Participant 6 months.
Secondary	Healthcare resource utilisation (e).	Measuring healthcare access by using the number of number of inpatient hospital admissions at 4 weeks.	Participant 4 weeks.
Secondary	Healthcare resource utilisation (e).	Measuring healthcare access by using the number of number of inpatient hospital admissions at 3 months.	Participant 3 months.
Secondary	Healthcare resource utilisation (e).	Measuring healthcare access by using the number of inpatient hospital admissions at 6 months.	Participant 6 months.
Secondary	Healthcare resource utilisation (f).	Measuring healthcare access by using the number of inpatient diagnostic tests at 4 weeks.	Participant 4 weeks.
Secondary	Healthcare resource utilisation (f).	Measuring healthcare access by using the number of inpatient diagnostic tests at 3 months.	Participant 3 months.
Secondary	Healthcare resource utilisation (f).	Measuring healthcare access by using the number of inpatient diagnostic tests at 6 months.	Participant 6 months.
Secondary	Intervention costs.	This will be measured by calculating the time cost of the training team and healthcare professionals, the cost of supplies and the equipment necessary to implement the intervention.	Participant 4 weeks.
Secondary	Intervention costs.	This will be measured by. calculating the time cost of the training team and healthcare professionals, the cost of supplies and the equipment necessary to implement the intervention.	Participant 3 months.
Secondary	Intervention costs	This will be measured by calculating the time cost of the training team and healthcare professionals, the cost of supplies and the equipment necessary to implement the intervention.	Participant 6 months.
Secondary	Medication at short-term time point (a)	Measured using the frequency per week in days, start and end date per medication at 4 weeks.	Participant 4 weeks.
Secondary	Medication at mid-term time point (a)	Measuring the frequency per week in days, start and end date per medication at 3 months.	Participant 3 months.
Secondary	Medication at long-term time point (a)	Measuring the frequency per week in days, start and end date per medication at 6 months.	Participant 6 months.
Secondary	Medication at short-term time point (b)	Measured using the dosage per day (mg), start and end date per medication at 4 weeks.	Participant 4 weeks.
Secondary	Medication at mid-term time point (b)	Measuring the dosage per day (mg), start and end date per medication at 3 months.	Participant 3 months.
Secondary	Medication at long-term time point (b)	Measuring the dosage per day (mg), start and end date per medication at 6 months.	Participant 6 months.