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Isometric Exercise for People With Raised Blood Pressure (IsoFIT-BP)

Primary Purpose

Hypertension

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Isometric Exercise
Standard care lifestyle advice
Sponsored by
East Kent Hospitals University NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hypertension focused on measuring Isometric exercise, Exercise, Hypertension, High blood pressure, General practice, Feasibility study

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Canterbury Medical Practice
  • Kent and Canterbury Hospital
  • Newton Place Surgery
  • St Helier Hospital
  • Maywood Healthcare Centre
  • Brighton Health and Wellbeing Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Control

Isometric Exercise

Arm Description

To receive standard care lifestyle advice only

To receive standard care lifestyle advice plus 3 sessions of isometric exercise per week

Outcomes

Primary Outcome Measures

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.
Change in systolic blood pressure (mmHg) from baseline to Week 4.
Change in systolic blood pressure (mmHg) from baseline to Month 3.
Change in systolic blood pressure (mmHg) from baseline to Month 6.

Secondary Outcome Measures

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.
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.
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.
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.
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.
Recruitment rates from data collected at sites.
This will be measured by calculating the average number of participants recruited per week.
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.
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.
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.
Change in diastolic blood pressure (mmHg) from baseline to Week 4.
Change in diastolic blood pressure (mmHg) from baseline to Month 3.
Change in diastolic blood pressure (mmHg) from baseline to Month 6.
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.
Participant experiences of undertaking isometric exercise.
Collected using participant study-specific survey with closed and open questions.
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.
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.
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.
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.
Healthcare resource utilisation (a).
Measuring healthcare access by using the number of GP visits at 4 weeks.
Healthcare resource utilisation (a).
Measuring healthcare access by using the number of GP visits at 3 months.
Healthcare resource utilisation (a).
Measuring healthcare access by using the number of GP visits at 6 months.
Healthcare resource utilisation (b).
Measuring healthcare access by using the number of nurse visits at 4 weeks.
Healthcare resource utilisation (b).
Measuring healthcare access by using the number of nurse visits at 3 months.
Healthcare resource utilisation (b).
Measuring healthcare access by using the number of nurse visits at 6 months.
Healthcare resource utilisation (c).
Measuring healthcare access by using the number of other health professionals visits at 4 weeks.
Healthcare resource utilisation (c).
Measuring healthcare access by using the number of other health professionals visits at 3 months.
Healthcare resource utilisation (c).
Measuring healthcare access by using the number of other health professionals visits at 6 months.
Healthcare resource utilisation (d).
Measuring healthcare access by using the number of number of A&E attendances at 4 weeks.
Healthcare resource utilisation (d).
Measuring healthcare access by using the number of number of A&E attendances at 3 months.
Healthcare resource utilisation (d).
Measuring healthcare access by using the number of number of A&E attendances at 6 months.
Healthcare resource utilisation (e).
Measuring healthcare access by using the number of number of inpatient hospital admissions at 4 weeks.
Healthcare resource utilisation (e).
Measuring healthcare access by using the number of number of inpatient hospital admissions at 3 months.
Healthcare resource utilisation (e).
Measuring healthcare access by using the number of inpatient hospital admissions at 6 months.
Healthcare resource utilisation (f).
Measuring healthcare access by using the number of inpatient diagnostic tests at 4 weeks.
Healthcare resource utilisation (f).
Measuring healthcare access by using the number of inpatient diagnostic tests at 3 months.
Healthcare resource utilisation (f).
Measuring healthcare access by using the number of inpatient diagnostic tests at 6 months.
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.
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.
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.
Medication at short-term time point (a)
Measured using the frequency per week in days, start and end date per medication at 4 weeks.
Medication at mid-term time point (a)
Measuring the frequency per week in days, start and end date per medication at 3 months.
Medication at long-term time point (a)
Measuring the frequency per week in days, start and end date per medication at 6 months.
Medication at short-term time point (b)
Measured using the dosage per day (mg), start and end date per medication at 4 weeks.
Medication at mid-term time point (b)
Measuring the dosage per day (mg), start and end date per medication at 3 months.
Medication at long-term time point (b)
Measuring the dosage per day (mg), start and end date per medication at 6 months.

Full Information

First Posted
April 19, 2021
Last Updated
September 14, 2023
Sponsor
East Kent Hospitals University NHS Foundation Trust
Collaborators
University of Kent, Canterbury Christ Church University
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1. Study Identification

Unique Protocol Identification Number
NCT04936022
Brief Title
Isometric Exercise for People With Raised Blood Pressure
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
November 30, 2022 (Actual)
Study Completion Date
November 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
East Kent Hospitals University NHS Foundation Trust
Collaborators
University of Kent, Canterbury Christ Church University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Isometric exercise, Exercise, Hypertension, High blood pressure, General practice, Feasibility study

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Multi-centre randomized controlled feasibility study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Other
Arm Description
To receive standard care lifestyle advice only
Arm Title
Isometric Exercise
Arm Type
Experimental
Arm Description
To receive standard care lifestyle advice plus 3 sessions of isometric exercise per week
Intervention Type
Other
Intervention Name(s)
Isometric Exercise
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Standard care lifestyle advice
Intervention Description
Healthy lifestyle advice for hypertension, given by a healthcare professional.
Primary Outcome Measure Information:
Title
Experience of intervention delivery
Description
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.
Time Frame
Project month 11
Title
Change in systolic blood pressure (mmHg) from baseline to Week 4.
Time Frame
Participant week 4
Title
Change in systolic blood pressure (mmHg) from baseline to Month 3.
Time Frame
Participant 3 months
Title
Change in systolic blood pressure (mmHg) from baseline to Month 6.
Time Frame
Participant 6 months
Secondary Outcome Measure Information:
Title
Early fidelity of the isometric exercise prescription.
Description
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.
Time Frame
Participant week 1
Title
Short-term fidelity of the isometric exercise prescription.
Description
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.
Time Frame
Participant week 4
Title
Short-term adherence to the Isometric exercise (IE) training.
Description
Measured using the proportion of participants (number) completing a minimum of 8 of 12 IE sessions up to the 4-week point.
Time Frame
Participant week 4
Title
Mid-term adherence to the Isometric exercise training.
Description
Measured using the proportion of participants (number) completing a minimum of two thirds of all IE sessions up to 3 months.
Time Frame
Participant 3 Months
Title
Long-term adherence to the Isometric exercise training.
Description
Measured using the proportion of participants (number) completing a minimum of two thirds of all IE sessions up to 6 months.
Time Frame
Participant 6 Months
Title
Recruitment rates from data collected at sites.
Description
This will be measured by calculating the average number of participants recruited per week.
Time Frame
Project month 10
Title
Short-term attrition rates from data collected at sites.
Description
This will be measured by calculating the number of withdrawals from the study up to 4 weeks.
Time Frame
Participant week 4
Title
Mid-term attrition rates from data collected at sites.
Description
This will be measured by calculating the number of withdrawals from the study up to 3 months.
Time Frame
Participant 3 months
Title
Long-term attrition rates from data collected at sites.
Description
This will be measured by calculating the number of withdrawals from the study up to 6 months.
Time Frame
Participant 6 months
Title
Change in diastolic blood pressure (mmHg) from baseline to Week 4.
Time Frame
Week 4
Title
Change in diastolic blood pressure (mmHg) from baseline to Month 3.
Time Frame
Month 3
Title
Change in diastolic blood pressure (mmHg) from baseline to Month 6.
Time Frame
Month 6
Title
Experience of isometric exercise intervention.
Description
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.
Time Frame
Month 11
Title
Participant experiences of undertaking isometric exercise.
Description
Collected using participant study-specific survey with closed and open questions.
Time Frame
Participant week 4.
Title
Subjective opinion of healthcare professionals on their willingness to consider the intervention as a treatment option for patients with Stage 1 hypertension.
Description
Collected using semi-structured interviews conducted by telephone with healthcare professionals from GP practices not taking part as study recruitment sites.
Time Frame
Project month 11.
Title
Short-term Quality-adjusted life years (QALYs) calculated from patients' responses to the EQ-5D-5L questionnaire.
Description
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.
Time Frame
Participant 4 weeks
Title
Mid-term Quality-adjusted life years calculated from patients' responses to the EQ-5D-5L questionnaire.
Description
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.
Time Frame
Participant 3 months
Title
Long-term Quality-adjusted life years calculated from patients' responses to the EQ-5D-5L questionnaire.
Description
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.
Time Frame
Participant 6 months
Title
Healthcare resource utilisation (a).
Description
Measuring healthcare access by using the number of GP visits at 4 weeks.
Time Frame
Participant 4 weeks.
Title
Healthcare resource utilisation (a).
Description
Measuring healthcare access by using the number of GP visits at 3 months.
Time Frame
Participant 3 months
Title
Healthcare resource utilisation (a).
Description
Measuring healthcare access by using the number of GP visits at 6 months.
Time Frame
Participant 6 months
Title
Healthcare resource utilisation (b).
Description
Measuring healthcare access by using the number of nurse visits at 4 weeks.
Time Frame
Participant 4 weeks.
Title
Healthcare resource utilisation (b).
Description
Measuring healthcare access by using the number of nurse visits at 3 months.
Time Frame
Participant 3 months.
Title
Healthcare resource utilisation (b).
Description
Measuring healthcare access by using the number of nurse visits at 6 months.
Time Frame
Participant 6 months.
Title
Healthcare resource utilisation (c).
Description
Measuring healthcare access by using the number of other health professionals visits at 4 weeks.
Time Frame
Participant 4 weeks.
Title
Healthcare resource utilisation (c).
Description
Measuring healthcare access by using the number of other health professionals visits at 3 months.
Time Frame
Participant 3 months.
Title
Healthcare resource utilisation (c).
Description
Measuring healthcare access by using the number of other health professionals visits at 6 months.
Time Frame
Participant 6 months.
Title
Healthcare resource utilisation (d).
Description
Measuring healthcare access by using the number of number of A&E attendances at 4 weeks.
Time Frame
Participant 4 weeks.
Title
Healthcare resource utilisation (d).
Description
Measuring healthcare access by using the number of number of A&E attendances at 3 months.
Time Frame
Participant 3 months.
Title
Healthcare resource utilisation (d).
Description
Measuring healthcare access by using the number of number of A&E attendances at 6 months.
Time Frame
Participant 6 months.
Title
Healthcare resource utilisation (e).
Description
Measuring healthcare access by using the number of number of inpatient hospital admissions at 4 weeks.
Time Frame
Participant 4 weeks.
Title
Healthcare resource utilisation (e).
Description
Measuring healthcare access by using the number of number of inpatient hospital admissions at 3 months.
Time Frame
Participant 3 months.
Title
Healthcare resource utilisation (e).
Description
Measuring healthcare access by using the number of inpatient hospital admissions at 6 months.
Time Frame
Participant 6 months.
Title
Healthcare resource utilisation (f).
Description
Measuring healthcare access by using the number of inpatient diagnostic tests at 4 weeks.
Time Frame
Participant 4 weeks.
Title
Healthcare resource utilisation (f).
Description
Measuring healthcare access by using the number of inpatient diagnostic tests at 3 months.
Time Frame
Participant 3 months.
Title
Healthcare resource utilisation (f).
Description
Measuring healthcare access by using the number of inpatient diagnostic tests at 6 months.
Time Frame
Participant 6 months.
Title
Intervention costs.
Description
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.
Time Frame
Participant 4 weeks.
Title
Intervention costs.
Description
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.
Time Frame
Participant 3 months.
Title
Intervention costs
Description
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.
Time Frame
Participant 6 months.
Title
Medication at short-term time point (a)
Description
Measured using the frequency per week in days, start and end date per medication at 4 weeks.
Time Frame
Participant 4 weeks.
Title
Medication at mid-term time point (a)
Description
Measuring the frequency per week in days, start and end date per medication at 3 months.
Time Frame
Participant 3 months.
Title
Medication at long-term time point (a)
Description
Measuring the frequency per week in days, start and end date per medication at 6 months.
Time Frame
Participant 6 months.
Title
Medication at short-term time point (b)
Description
Measured using the dosage per day (mg), start and end date per medication at 4 weeks.
Time Frame
Participant 4 weeks.
Title
Medication at mid-term time point (b)
Description
Measuring the dosage per day (mg), start and end date per medication at 3 months.
Time Frame
Participant 3 months.
Title
Medication at long-term time point (b)
Description
Measuring the dosage per day (mg), start and end date per medication at 6 months.
Time Frame
Participant 6 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher K Farmer
Organizational Affiliation
University of Kent
Official's Role
Study Director
Facility Information:
Facility Name
Canterbury Medical Practice
City
Canterbury
State/Province
Kent
ZIP/Postal Code
CT45BL
Country
United Kingdom
Facility Name
Kent and Canterbury Hospital
City
Canterbury
State/Province
Kent
Country
United Kingdom
Facility Name
Newton Place Surgery
City
Faversham
State/Province
Kent
ZIP/Postal Code
ME138FH
Country
United Kingdom
Facility Name
St Helier Hospital
City
Carshalton
State/Province
Surrey
ZIP/Postal Code
SM51AA
Country
United Kingdom
Facility Name
Maywood Healthcare Centre
City
Bognor Regis
State/Province
West Sussex
ZIP/Postal Code
PO212UW
Country
United Kingdom
Facility Name
Brighton Health and Wellbeing Centre
City
Hove
ZIP/Postal Code
BN31AE
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Jonathan Wiles (jim.wiles@canterbury.ac.uk). The data will become available 1 year after the study finishes which will be approximately December 2022 and may be accessed for up to 5 years. Anonymised data may be accessed by researchers at universities, NHS organisations or other healthcare providers where the sharing of data has a clearly defined purpose and its use will be of benefit to wider society. Data will be shared by secure data transfer. Consent from participants was obtained for the use of their information for future research and to be shared anonymously with other researchers.

Learn more about this trial

Isometric Exercise for People With Raised Blood Pressure

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