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

September 14, 2023 updated by: East Kent Hospitals University NHS Foundation Trust

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
84

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United Kingdom
      • Hove, United Kingdom, BN31AE
        • Brighton Health and Wellbeing Centre
    • Kent
      • Canterbury, Kent, United Kingdom, CT45BL
        • Canterbury Medical Practice
      • Canterbury, Kent, United Kingdom
        • Kent and Canterbury Hospital
      • Faversham, Kent, United Kingdom, ME138FH
        • Newton Place Surgery
    • Surrey
      • Carshalton, Surrey, United Kingdom, SM51AA
        • St Helier Hospital
    • West Sussex
      • Bognor Regis, West Sussex, United Kingdom, PO212UW
        • Maywood Healthcare Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Control
To receive standard care lifestyle advice only
Behavioral: Standard care lifestyle advice
Healthy lifestyle advice for hypertension, given by a healthcare professional.
Experimental: Isometric Exercise
To receive standard care lifestyle advice plus 3 sessions of isometric exercise per week
Behavioral: Standard care lifestyle advice
Healthy lifestyle advice for hypertension, given by a healthcare professional.
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Experience of intervention delivery
Time Frame: Project month 11
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
Change in systolic blood pressure (mmHg) from baseline to Week 4.
Time Frame: Participant week 4
Participant week 4
Change in systolic blood pressure (mmHg) from baseline to Month 3.
Time Frame: Participant 3 months
Participant 3 months
Change in systolic blood pressure (mmHg) from baseline to Month 6.
Time Frame: Participant 6 months
Participant 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Early fidelity of the isometric exercise prescription.
Time Frame: Participant week 1
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
Short-term fidelity of the isometric exercise prescription.
Time Frame: Participant week 4
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
Short-term adherence to the Isometric exercise (IE) training.
Time Frame: Participant week 4
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
Mid-term adherence to the Isometric exercise training.
Time Frame: Participant 3 Months
Measured using the proportion of participants (number) completing a minimum of two thirds of all IE sessions up to 3 months.
Participant 3 Months
Long-term adherence to the Isometric exercise training.
Time Frame: Participant 6 Months
Measured using the proportion of participants (number) completing a minimum of two thirds of all IE sessions up to 6 months.
Participant 6 Months
Recruitment rates from data collected at sites.
Time Frame: Project month 10
This will be measured by calculating the average number of participants recruited per week.
Project month 10
Short-term attrition rates from data collected at sites.
Time Frame: Participant week 4
This will be measured by calculating the number of withdrawals from the study up to 4 weeks.
Participant week 4
Mid-term attrition rates from data collected at sites.
Time Frame: Participant 3 months
This will be measured by calculating the number of withdrawals from the study up to 3 months.
Participant 3 months
Long-term attrition rates from data collected at sites.
Time Frame: Participant 6 months
This will be measured by calculating the number of withdrawals from the study up to 6 months.
Participant 6 months
Change in diastolic blood pressure (mmHg) from baseline to Week 4.
Time Frame: Week 4
Week 4
Change in diastolic blood pressure (mmHg) from baseline to Month 3.
Time Frame: Month 3
Month 3
Change in diastolic blood pressure (mmHg) from baseline to Month 6.
Time Frame: Month 6
Month 6
Experience of isometric exercise intervention.
Time Frame: Month 11
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
Participant experiences of undertaking isometric exercise.
Time Frame: Participant week 4.
Collected using participant study-specific survey with closed and open questions.
Participant week 4.
Subjective opinion of healthcare professionals on their willingness to consider the intervention as a treatment option for patients with Stage 1 hypertension.
Time Frame: Project month 11.
Collected using semi-structured interviews conducted by telephone with healthcare professionals from GP practices not taking part as study recruitment sites.
Project month 11.
Short-term Quality-adjusted life years (QALYs) calculated from patients' responses to the EQ-5D-5L questionnaire.
Time Frame: Participant 4 weeks
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
Mid-term Quality-adjusted life years calculated from patients' responses to the EQ-5D-5L questionnaire.
Time Frame: Participant 3 months
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
Long-term Quality-adjusted life years calculated from patients' responses to the EQ-5D-5L questionnaire.
Time Frame: Participant 6 months
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
Healthcare resource utilisation (a).
Time Frame: Participant 4 weeks.
Measuring healthcare access by using the number of GP visits at 4 weeks.
Participant 4 weeks.
Healthcare resource utilisation (a).
Time Frame: Participant 3 months
Measuring healthcare access by using the number of GP visits at 3 months.
Participant 3 months
Healthcare resource utilisation (a).
Time Frame: Participant 6 months
Measuring healthcare access by using the number of GP visits at 6 months.
Participant 6 months
Healthcare resource utilisation (b).
Time Frame: Participant 4 weeks.
Measuring healthcare access by using the number of nurse visits at 4 weeks.
Participant 4 weeks.
Healthcare resource utilisation (b).
Time Frame: Participant 3 months.
Measuring healthcare access by using the number of nurse visits at 3 months.
Participant 3 months.
Healthcare resource utilisation (b).
Time Frame: Participant 6 months.
Measuring healthcare access by using the number of nurse visits at 6 months.
Participant 6 months.
Healthcare resource utilisation (c).
Time Frame: Participant 4 weeks.
Measuring healthcare access by using the number of other health professionals visits at 4 weeks.
Participant 4 weeks.
Healthcare resource utilisation (c).
Time Frame: Participant 3 months.
Measuring healthcare access by using the number of other health professionals visits at 3 months.
Participant 3 months.
Healthcare resource utilisation (c).
Time Frame: Participant 6 months.
Measuring healthcare access by using the number of other health professionals visits at 6 months.
Participant 6 months.
Healthcare resource utilisation (d).
Time Frame: Participant 4 weeks.
Measuring healthcare access by using the number of number of A&E attendances at 4 weeks.
Participant 4 weeks.
Healthcare resource utilisation (d).
Time Frame: Participant 3 months.
Measuring healthcare access by using the number of number of A&E attendances at 3 months.
Participant 3 months.
Healthcare resource utilisation (d).
Time Frame: Participant 6 months.
Measuring healthcare access by using the number of number of A&E attendances at 6 months.
Participant 6 months.
Healthcare resource utilisation (e).
Time Frame: Participant 4 weeks.
Measuring healthcare access by using the number of number of inpatient hospital admissions at 4 weeks.
Participant 4 weeks.
Healthcare resource utilisation (e).
Time Frame: Participant 3 months.
Measuring healthcare access by using the number of number of inpatient hospital admissions at 3 months.
Participant 3 months.
Healthcare resource utilisation (e).
Time Frame: Participant 6 months.
Measuring healthcare access by using the number of inpatient hospital admissions at 6 months.
Participant 6 months.
Healthcare resource utilisation (f).
Time Frame: Participant 4 weeks.
Measuring healthcare access by using the number of inpatient diagnostic tests at 4 weeks.
Participant 4 weeks.
Healthcare resource utilisation (f).
Time Frame: Participant 3 months.
Measuring healthcare access by using the number of inpatient diagnostic tests at 3 months.
Participant 3 months.
Healthcare resource utilisation (f).
Time Frame: Participant 6 months.
Measuring healthcare access by using the number of inpatient diagnostic tests at 6 months.
Participant 6 months.
Intervention costs.
Time Frame: Participant 4 weeks.
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.
Intervention costs.
Time Frame: Participant 3 months.
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.
Intervention costs
Time Frame: Participant 6 months.
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.
Medication at short-term time point (a)
Time Frame: Participant 4 weeks.
Measured using the frequency per week in days, start and end date per medication at 4 weeks.
Participant 4 weeks.
Medication at mid-term time point (a)
Time Frame: Participant 3 months.
Measuring the frequency per week in days, start and end date per medication at 3 months.
Participant 3 months.
Medication at long-term time point (a)
Time Frame: Participant 6 months.
Measuring the frequency per week in days, start and end date per medication at 6 months.
Participant 6 months.
Medication at short-term time point (b)
Time Frame: Participant 4 weeks.
Measured using the dosage per day (mg), start and end date per medication at 4 weeks.
Participant 4 weeks.
Medication at mid-term time point (b)
Time Frame: Participant 3 months.
Measuring the dosage per day (mg), start and end date per medication at 3 months.
Participant 3 months.
Medication at long-term time point (b)
Time Frame: Participant 6 months.
Measuring the dosage per day (mg), start and end date per medication at 6 months.
Participant 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
East Kent Hospitals University NHS Foundation Trust

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Kent
Canterbury Christ Church University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Christopher K Farmer, University of Kent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 19, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 23, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 15, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NIHR200485
  • 13472393 (Registry Identifier: ISRCTN)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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