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

NCT03423433 | Completed

• 1 other identifier: RKE_2017_002
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke

Keywords

Chronic; Stroke; Blood Pressure; Oxygen Perfusion; Stroop; Cognitive Performance; Cognition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Pulse wave velocity

  After three data collection sessions (within 2 weeks) and 10 weeks- post

• Cerebral perfusion

  After three data collection sessions (within 2 weeks) and 10 weeks- post

• Cognitive performance

  After three data collection sessions (within 2 weeks) and 10 weeks- post

Study Arms (2)

Control condition

NO INTERVENTION

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 (heel raise) condition

EXPERIMENTAL

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

Interventions

Heel raise intervention BEHAVIORAL

A daily heel-raise programme for ten weeks to determine any chronic effects of heel raises on the previously mentioned variables.

Experimental (heel raise) condition

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Diabetics
• Inability to perform heel raise motion

Sponsors & Collaborators

• University of Winchester: lead

Study Sites (1)

University of Winchester

Winchester, Hampshire, SO22 4NR, United Kingdom

Location

MeSH Terms

Conditions

Stroke; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2017
• First Posted: February 6, 2018
• Study Start: June 1, 2018
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: January 18, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)