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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03423433
• Other study ID #: RKE_2017_002
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: May 1, 2019

Study information

• Verified date: January 2020
• Source: University of Winchester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 1, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	University of Winchester	Winchester	Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Winchester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Central and peripheral blood pressure	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	Pulse wave velocity	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
Secondary	Cerebral perfusion	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
Secondary	Cognitive performance	Stroop task performance due to heel raises	After three data collection sessions (within 2 weeks) and 10 weeks- post