Isometric Exercise for People With Raised Blood Pressure
IsoFIT-BP
Feasibility Study to Assess the Delivery of a Novel Isometric Exercise Intervention for People With Stage 1 Hypertension in the NHS
2 other identifiers
interventional
84
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable hypertension
Started Feb 2020
Typical duration for not_applicable hypertension
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2020
CompletedFirst Submitted
Initial submission to the registry
April 19, 2021
CompletedFirst Posted
Study publicly available on registry
June 23, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2022
CompletedSeptember 15, 2023
September 1, 2023
2.8 years
April 19, 2021
September 14, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
Change in systolic blood pressure (mmHg) from baseline to Week 4.
Participant week 4
Change in systolic blood pressure (mmHg) from baseline to Month 3.
Participant 3 months
Change in systolic blood pressure (mmHg) from baseline to Month 6.
Participant 6 months
Secondary Outcomes (45)
Early fidelity of the isometric exercise prescription.
Participant week 1
Short-term fidelity of the isometric exercise prescription.
Participant week 4
Short-term adherence to the Isometric exercise (IE) training.
Participant week 4
Mid-term adherence to the Isometric exercise training.
Participant 3 Months
Long-term adherence to the Isometric exercise training.
Participant 6 Months
- +40 more secondary outcomes
Study Arms (2)
Control
OTHERTo receive standard care lifestyle advice only
Isometric Exercise
EXPERIMENTALTo receive standard care lifestyle advice plus 3 sessions of isometric exercise per week
Interventions
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).
Healthy lifestyle advice for hypertension, given by a healthcare professional.
Eligibility Criteria
You may qualify if:
- Aged 18 or over
- Clinic systolic BP 140-159 mmHg
- Able to provide informed consent
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- East Kent Hospitals University NHS Foundation Trustlead
- University of Kentcollaborator
- Canterbury Christ Church Universitycollaborator
Study Sites (6)
Canterbury Medical Practice
Canterbury, Kent, CT45BL, United Kingdom
Kent and Canterbury Hospital
Canterbury, Kent, United Kingdom
Newton Place Surgery
Faversham, Kent, ME138FH, United Kingdom
St Helier Hospital
Carshalton, Surrey, SM51AA, United Kingdom
Maywood Healthcare Centre
Bognor Regis, West Sussex, PO212UW, United Kingdom
Brighton Health and Wellbeing Centre
Hove, BN31AE, United Kingdom
Related Publications (1)
Wiles JD, Santer E, Rees-Roberts M, Borthwick R, Doulton T, Swift PA, Pellatt-Higgins T, Saxby K, Mills A, Gousia K, MacInnes D, O'Driscoll J, West A, Darby J, Short V, Farmer CK. Feasibility randomised controlled trial to assess the delivery of a novel isometric exercise intervention for people diagnosed with uncomplicated stage 1 hypertension in the National Health Service: key quantitative findings. BMJ Open. 2025 Jun 4;15(6):e091219. doi: 10.1136/bmjopen-2024-091219.
PMID: 40467325DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Christopher K Farmer
University of Kent
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 19, 2021
First Posted
June 23, 2021
Study Start
February 1, 2020
Primary Completion
November 30, 2022
Study Completion
November 30, 2022
Last Updated
September 15, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, CSR
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.