NCT06027294

Brief Summary

The muscles of stroke survivors can fatigue faster compared to muscles in people who have not had a stroke, which can limit how long a person with stroke can perform tasks such as walking. This study will examine how blood flow is regulated to the exercising leg muscle post-stroke, because if the muscle does not receive enough blood flow it will become fatigued. Finally, the investigators will use a safe and simple non-invasive intervention called ischemic conditioning, which has known effects to improve blood flow to exercising muscle and determine the effects on muscle fatigue.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
26mo left

Started Jan 2024

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress52%
Jan 2024Jun 2028

First Submitted

Initial submission to the registry

August 30, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 7, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

January 11, 2024

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

September 25, 2025

Status Verified

September 1, 2025

Enrollment Period

4.5 years

First QC Date

August 30, 2023

Last Update Submit

September 22, 2025

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

  • Functional Sympatholysis Magnitude

    Functional sympatholysis will be measured as a change in leg vascular conductance (in ml/min/mmHg) from the exercise control condition to the exercise + cold pressor test condition.

    Years 3-5

Secondary Outcomes (4)

  • Time to muscle fatigue

    Years 3-5

  • Change in motor unit firing rates

    Years 3-5

  • Change in muscle metabolite accumulation will include muscle pH

    Years 3-5

  • Change in muscle metabolite accumulation

    Years 3-5

Study Arms (2)

Ischemic Conditioning

EXPERIMENTAL

Ischemic conditioning is a well-defined, non-invasive procedure which consists of inflating a blood pressure cuff around a limb (in our study, the paretic leg), inflating the cuff to 225 mmHg to occlude blood flow to the limb for 5 minutes, releasing the cuff for 5 minutes, and repeating 5 times. In our study, participants will receive six sessions of ischemic conditioning over the course of two weeks.

Procedure: Ischemic Conditioning

Ischemic Conditioning Sham

SHAM COMPARATOR

There will also be an IC Sham group which is identical to the IC intervention, except the cuff will only be inflated to 10 mmHg, which is not a high enough pressure to occlude arterial blood flow.

Procedure: Ischemic Conditioning

Interventions

Ischemic ConditioningPROCEDURE

A cuff will be inflated to a pressure of 225 mmHg.

Ischemic ConditioningIschemic Conditioning Sham

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be between 18-85 years of age
  • Able to give informed consent
  • ≥6 months post diagnosis of unilateral cortical or sub-cortical stroke
  • English speaking

You may not qualify if:

  • History of blood clots in the extremities or any condition in which compression of the thigh or transient ischemia is contraindicated (e.g. wounds in the leg)
  • Chronic pain syndrome
  • Low back or hip pain that interferes with lower extremity motor testing
  • History of head trauma
  • Comorbid neurological disorder
  • Peripheral vascular disease
  • Myocardial infarction in the previous year
  • Inability to follow 2 step commands
  • Condition where fatiguing contractions or resisted leg contractions are contraindicated
  • Resting SBP ≥160 mmHg or DBP ≥ 110 mmHg
  • Pregnancy or breastfeeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Marquette University

Milwaukee, Wisconsin, 53233, United States

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Matthew Durand, Ph.D.

CONTACT

4149555619mdurand@mcw.edu

Jennifer Nguyen, BS

CONTACT

jnguyen@mcw.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 30, 2023

First Posted

September 7, 2023

Study Start

January 11, 2024

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2028

Last Updated

September 25, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(2)