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Completed

NCT Number: NCT04936022

Isometric Exercise for People With Raised Blood Pressure

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.

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Key information

Conditions

Hypertension Behavior Cardiovascular Diseases Motor Activity Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Canterbury Medical Practice, Canterbury, Kent, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Isometric exercise

Other

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).

Standard care lifestyle advice

Behavioral

Healthy lifestyle advice for hypertension, given by a healthcare professional.

Primary outcomes

  1. 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.

  2. Change in systolic blood pressure (mmHg) from baseline to Week 4.

    Time frame: Participant week 4

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

    Time frame: Participant 3 months

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

    Time frame: Participant 6 months

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. Change in diastolic blood pressure (mmHg) from baseline to Week 4.

    Time frame: Week 4

  11. Change in diastolic blood pressure (mmHg) from baseline to Month 3.

    Time frame: Month 3

  12. Change in diastolic blood pressure (mmHg) from baseline to Month 6.

    Time frame: Month 6

  13. 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.

  14. Participant experiences of undertaking isometric exercise.

    Time frame: Participant week 4.

    Collected using participant study-specific survey with closed and open questions.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. Healthcare resource utilisation (a).

    Time frame: Participant 4 weeks.

    Measuring healthcare access by using the number of GP visits at 4 weeks.

  20. Healthcare resource utilisation (a).

    Time frame: Participant 3 months

    Measuring healthcare access by using the number of GP visits at 3 months.

  21. Healthcare resource utilisation (a).

    Time frame: Participant 6 months

    Measuring healthcare access by using the number of GP visits at 6 months.

  22. Healthcare resource utilisation (b).

    Time frame: Participant 4 weeks.

    Measuring healthcare access by using the number of nurse visits at 4 weeks.

  23. Healthcare resource utilisation (b).

    Time frame: Participant 3 months.

    Measuring healthcare access by using the number of nurse visits at 3 months.

  24. Healthcare resource utilisation (b).

    Time frame: Participant 6 months.

    Measuring healthcare access by using the number of nurse visits at 6 months.

  25. Healthcare resource utilisation (c).

    Time frame: Participant 4 weeks.

    Measuring healthcare access by using the number of other health professionals visits at 4 weeks.

  26. Healthcare resource utilisation (c).

    Time frame: Participant 3 months.

    Measuring healthcare access by using the number of other health professionals visits at 3 months.

  27. Healthcare resource utilisation (c).

    Time frame: Participant 6 months.

    Measuring healthcare access by using the number of other health professionals visits at 6 months.

  28. 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.

  29. 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.

  30. 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.

  31. 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.

  32. 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.

  33. Healthcare resource utilisation (e).

    Time frame: Participant 6 months.

    Measuring healthcare access by using the number of inpatient hospital admissions at 6 months.

  34. Healthcare resource utilisation (f).

    Time frame: Participant 4 weeks.

    Measuring healthcare access by using the number of inpatient diagnostic tests at 4 weeks.

  35. Healthcare resource utilisation (f).

    Time frame: Participant 3 months.

    Measuring healthcare access by using the number of inpatient diagnostic tests at 3 months.

  36. Healthcare resource utilisation (f).

    Time frame: Participant 6 months.

    Measuring healthcare access by using the number of inpatient diagnostic tests at 6 months.

  37. 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.

  38. 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.

  39. 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.

  40. 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.

  41. 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.

  42. 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.

  43. 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.

  44. 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.

  45. 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.

Sponsors and collaborators

Lead sponsor

East Kent Hospitals University NHS Foundation Trust

Other Gov

Collaborators

  • Canterbury Christ Church University
  • University of Kent

Registry information

Official study title

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

Acronym: IsoFIT-BP

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 23, 2021
Registry last updated
Sep 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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