The Acute and Chronic Effects of a Heel Raise Programme on Central Blood Pressure, Arterial Compliance and Oxygen Perfusion After Stroke

January 16, 2020 updated by: University of Winchester

The Acute and Chronic Effects of Heel Raises on Central Blood Pressures, Arterial Compliance and Cerebral and Peripheral Oxygen Perfusion After Stroke

Physical inactivity and increased sedentary time are linked to increased blood pressure and may cause decreases in peripheral and cerebral oxygen perfusion in stroke survivors. Nonetheless, stroke survivors are significantly less active than their healthy counterparts due to physical incapability or a lack of confidence in physical capability. This study will determine whether a simple and non-demanding movement such as repeated heel raises are able to cause acute and chronic decreases in peripheral and central blood pressure and increases in oxygen perfusion and cognitive performance.

Thirty participants will be recruited to this study. All will take part in four sessions. One familiarisation session will acclimatise participants to the equipment used involving central and peripheral blood pressures, pulse wave velocity, arterial stiffness, maximal voluntary contractions of the medial gastrocnemius and Stroop tasks.. Two experimental sessions will take place involving extended sedentary time (one involving uninterrupted sedentary time and one including ten heel raises every ten minutes). A control condition of 15 participants will then be tested ten weeks post-. The experimental condition of 15 participants will undergo a ten-week heel raise prescribed programme before having peripheral and central blood pressure, pulse wave velocity, arterial stiffness, peripheral and cerebral oxygen perfusion, cognitive performance and maximal voluntary contraction of the medial gastrocnemius assessed after their programme.

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.

Detailed Description

After stroke, individuals are more sedentary than their healthy counterparts, with significantly more daily seated time and significantly fewer daily steps with activity levels impaired both immediately post- event and 6 months into recovery. Physical inactivity and increased sedentary time are linked to increased blood pressure; a cause of both incident and recurrent stroke. After stroke, victims suffer from a wide range of complications in terms of physical and cognitive abilities. Hypertension reduces cognitive performance in healthy and clinical populations, and stroke patients are frequently unable (for either physical or psychological reasons) to be physically active enough to reduce blood pressure and maximise cognitive improvements.

Prolonged seated time may also lead to reduced cerebral and peripheral oxygen perfusion. Heel raises may have the potential to improve these parameters without being too physically demanding on a clinical population. This study will investigate whether prescribed heel raises can have an acute and/or chronic effect on peripheral and central blood pressures, measures of central systolic loading, peripheral and cerebral oxygen perfusion and cognitive performance.

This study will recruit thirty chronic stroke sufferers from a local stroke groups. Visit will take place in the morning in a fasted state.

In the first visit, participants will undertake five stroop familiarisation tests. Stroop tests allow assessment of cognitive function. Demographic measures will be taken and baseline pulse wave analysis (PWA [SphygmoCor XCEL]) and pulse wave velocity (PWV) measures will be recorded. Heel raises will be demonstrated to the participants and displayed in a diagram. Participants will practice this movement before maximum voluntary contractions (MVC) will be measured using electromyography.

On each of the second two visits, participants will rest in a seated position for 20 minutes before having PWA, PWV and near infra-red spectroscopy (NIRS) measured at baseline to provide both peripheral and central blood pressures, arterial stiffness, cerebral and peripheral oxygen perfusion. Participants will then either undergo a 180 minute seated protocol or a 180 minute calf raising protocol (10 calf raises per 10 minutes) After 10, 30, 60, 90, 120, 150 and 170 minutes in both protocols, PWA, PWV and Stroop test results will be recorded. EMG will record muscle activation of the affected medial gastrocnemius during heel raises after each 30 minutes. NIRS will continuously record throughout the data collection process. Participants will watch a calming TV show (e.g. a David Attenborough documentary) to pass time without raising blood pressure. Statistical analysis will determine whether the heel raises caused acute alterations in peripheral and central blood pressures, pulse wave velocity, cerebral and peripheral blood flow, muscle activation and cognitive performance.

The control condition of fifteen participants will then return after ten weeks and undertake a duplicate of session 1. An experimental condition of fifteen participants will undertake a ten week programme involving prescribed heel raises every day. They will then return after ten weeks and receive an identical session to their first session, allowing the chronic effect of prescribed heel raises to be observed.

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.
15

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 Locations

  • United Kingdom
    • Hampshire
      • Winchester, Hampshire, United Kingdom, SO22 4NR
        • University of Winchester

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Have experienced a stroke in the past ten years
  • Physically capable of heel raise motion

Exclusion Criteria:

  • Diabetics
  • Inability to perform heel raise motion

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: Prevention
  • 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.
No Intervention: Control condition

This condition will recruit fifteen chronic stroke sufferers. In the first visit, participants will undertake five Stroop familiarisation tests alongside baseline pulse wave analysis (PWA) and pulse wave velocity (PWV). Participants will practice this movement before maximum voluntary contractions (MVC) will be measured using electromyography.

During the second two visits, participants will have either undergo a 180 minute seated protocol or a 180 minute heel raising protocol (10 heel raises per 10 minutes) After 10, 30, 90, 120, 150 and 180 minutes in both protocols, PWA, PWV and Stroop task results will be recorded. NIRS will measure peripheral and cerebral oxygen perfusion throughout the 180 minutes. EMG will record muscle activation during heel raises after each 30 minutes.

Ten weeks after these sessions have been completed, participants will return to the laboratory for follow-up a session assessing resting measures in an identical protocol to the first visit.
Experimental: Experimental (heel raise) condition

This condition will recruit fifteen chronic stroke sufferers. In the first visit, participants will undertake five Stroop familiarisation tests alongside baseline pulse wave analysis (PWA) and pulse wave velocity (PWV). Participants will practice this movement before maximum voluntary contractions (MVC) will be measured using electromyography. During the second two visits, participants will have undergo a 180 minute seated or a 180 minute heel raise protocol (10 heel raises per 10 minutes) After 10, 30, 90, 120, 150 and 180 minutes, PWA, PWV and Stroop task results will be recorded. NIRS will measure peripheral and cerebral oxygen perfusion throughout. EMG will record muscle activation during heel raises after each 30 minutes.

Participants in this arm will be prescribed a ten-week heel-raise programme involving hourly heel raises. Ten weeks later, participants will return to the laboratory for follow-up sessions assessing resting measures in an identical protocol to the first visit.
Behavioral: Heel raise intervention
A daily heel-raise programme for ten weeks to determine any chronic effects of heel raises on the previously mentioned variables.

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
Central and peripheral blood pressure
Time Frame: After three data collection sessions (within 2 weeks) and 10 weeks- post
Acute and chronic changes to central and peripheral blood pressures due to heel raises
After three data collection sessions (within 2 weeks) and 10 weeks- post

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
Pulse wave velocity
Time Frame: After three data collection sessions (within 2 weeks) and 10 weeks- post
Acute and chronic changes to carotid-femoral pulse wave velocity due to heel raises
After three data collection sessions (within 2 weeks) and 10 weeks- post
Cerebral perfusion
Time Frame: After three data collection sessions (within 2 weeks) and 10 weeks- post
Acute and chronic changes to cerebral perfusion (Near infra-red spectroscopy) due to heel raises
After three data collection sessions (within 2 weeks) and 10 weeks- post
Cognitive performance
Time Frame: After three data collection sessions (within 2 weeks) and 10 weeks- post
Stroop task performance due to heel raises
After three data collection sessions (within 2 weeks) and 10 weeks- post

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.
University of Winchester

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.
June 1, 2018

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.
May 1, 2019

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.
May 1, 2019

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).
November 15, 2017

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.
February 5, 2018

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.
February 6, 2018

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.
January 18, 2020

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.
January 16, 2020

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.
January 1, 2020

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.
  • RKE_2017_002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No IPD sharing.

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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