The Effect of Ischemic Conditioning on Strength and Ambulation in Subjects With PAD
Primary Purpose
Peripheral Arterial Disease, Peripheral Vascular Disease, Amputation
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ischemic Conditioning Low - Sham Comparator
Ischemic Conditioning High - Active Comparator
Sponsored by
About this trial
This is an interventional basic science trial for Peripheral Arterial Disease
Eligibility Criteria
Inclusion Criteria:
- 18 years or older
- Able to ambulate independently without the use of aids (i.e., walking cane)
- Able to walk at least 10 minutes continuously without stopping
- History of diagnosed peripheral artery disease.
- For Amputees: History lower limb unilateral transtibial or transfemoral amputation.
Exclusion Criteria:
- Inability to give informed consent
- neurological disorder that affects gait
- two or more falls within the previous 12 months
- currently pregnant (or intend to become pregnant while participating in study)
- history of any condition where fatiguing contractions or resisted leg contractions are contraindicated
- blood clots in the leg, or any condition in which compression of the thigh or transient ischemia is contraindicated (e.g. open wounds in the leg).
- history of hypertension
- history of heart failure
- Head injury within the previous 6 months
- Seizure disorder
- Adverse reaction to ultrasound gel
- History of thrombosis
- History of sickle cell trait
Sites / Locations
- UIC Physical Therapy Faculty PracticeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Active Comparator
Arm Label
Ischemic Conditioning Low
Ischemic Conditioning High
Arm Description
Blood flow restriction with low compression
Blood flow restriction with high compression
Outcomes
Primary Outcome Measures
Change in quadriceps strength
Quadriceps strength assessed by a Biodex dynamometer
Change in gait kinematics
Gait mechanics assessed by joint angles using Vicon cameras and reflective markers
Change in gait kinetics
Gait mechanics assessed by joint forces using a Bertec instrumented treadmill in combination with gait kinematics
Change in gait metabolics
Assessment of oxygen consumption during walking using a metabolic cart
Secondary Outcome Measures
Six-minute walk test
Measurement of distance walked in six minutes
Full Information
NCT ID
NCT04937179
First Posted
May 27, 2021
Last Updated
April 13, 2023
Sponsor
University of Illinois at Chicago
Collaborators
American Heart Association
1. Study Identification
Unique Protocol Identification Number
NCT04937179
Brief Title
The Effect of Ischemic Conditioning on Strength and Ambulation in Subjects With PAD
Official Title
The Effect of Ischemic Conditioning on Strength and Ambulation in Subjects With Peripheral Artery Disease (PAD)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago
Collaborators
American Heart Association
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Lower limb amputation is common in the United States, with approximately 150,000 amputations annually. Most individuals walking with a prosthesis demonstrate asymmetrical loading-i.e., they favor the amputated side by placing more weight and increased ground reaction forces through the intact limb-which likely contributes to increased metabolic cost of walking. Lack of adequate muscular strength in the lower limb to attenuate these forces places increased stress on the joints, which may be displaced proximally, and may play a role in reported knee and hip pain in the intact limb.
Lower limb muscle weakness following amputation has been well documented. Increasing quadriceps strength is important after an amputation because it is positively correlated with gait speed. Gait speed may also be associated with successful community mobility, which leads to improved quality of life following amputation. Individuals with amputation who resume an active lifestyle are able to maintain strength. However, these individuals represent a minority of persons with lower limb amputation; most individuals report more barriers than motivators to adopt an active lifestyle.
Ischemic conditioning (IC) may strengthen leg muscles and reduce the metabolic cost of activity after amputation. In IC, the limb is exposed to brief, repeated bouts of ischemia (reduced blood flow) immediately followed by reperfusion. IC has been shown to improve muscle performance in healthy and diseased populations. IC has also been used more recently in patients with peripheral artery disease (PAD) as an intervention to improve function, such as walking ability. Acute exposure to IC increases muscle strength and activation, both in healthy, active individuals and in those with severe neuromuscular dysfunction, such as stroke survivors. IC also attenuates muscular fatigue. Increased fatigue resistance at submaximal contraction levels following IC may be due to increased neural activation of skeletal muscle. Changes in neural activation of muscle may be particularly beneficial during cortical reorganization after amputation. Reduced quadriceps fatigue during submaximal activities may also drive changes in gait kinematics, such as increased knee flexion during loading and mid-stance. Exposure to IC may also increase the oxidative properties of skeletal muscle, offering a direct pathway to reduce metabolic cost. Therefore, IC may lead to cellular changes that lower the metabolic cost of activity.
The primary aim of this study is to quantify the benefits of acute and chronic IC on quadriceps strength and walking economy in individuals with PAD and history of lower limb amputation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease, Peripheral Vascular Disease, Amputation, Lower Limb Amputation Knee, Lower Limb Amputation Above Knee (Injury), Lower Limb Amputation Below Knee (Injury)
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ischemic Conditioning Low
Arm Type
Sham Comparator
Arm Description
Blood flow restriction with low compression
Arm Title
Ischemic Conditioning High
Arm Type
Active Comparator
Arm Description
Blood flow restriction with high compression
Intervention Type
Procedure
Intervention Name(s)
Ischemic Conditioning Low - Sham Comparator
Intervention Description
The use of a Hokanson rapid inflator cuff to restrict blood flow at 25mmHg for 5 minutes followed by a 5 minute reperfusion period, repeated for 5 cycles.
Intervention Type
Procedure
Intervention Name(s)
Ischemic Conditioning High - Active Comparator
Intervention Description
The use of a Hokanson rapid inflator cuff to restrict blood flow at 225mmHg for 5 minutes followed by a 5 minute reperfusion period, repeated for 5 cycles.
Primary Outcome Measure Information:
Title
Change in quadriceps strength
Description
Quadriceps strength assessed by a Biodex dynamometer
Time Frame
through study completion, an average of 6 weeks
Title
Change in gait kinematics
Description
Gait mechanics assessed by joint angles using Vicon cameras and reflective markers
Time Frame
through study completion, an average of 6 weeks
Title
Change in gait kinetics
Description
Gait mechanics assessed by joint forces using a Bertec instrumented treadmill in combination with gait kinematics
Time Frame
through study completion, an average of 6 weeks
Title
Change in gait metabolics
Description
Assessment of oxygen consumption during walking using a metabolic cart
Time Frame
through study completion, an average of 6 weeks
Secondary Outcome Measure Information:
Title
Six-minute walk test
Description
Measurement of distance walked in six minutes
Time Frame
through study completion, an average of 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years or older
Able to ambulate independently without the use of aids (i.e., walking cane)
Able to walk at least 10 minutes continuously without stopping
History of diagnosed peripheral artery disease.
For Amputees: History lower limb unilateral transtibial or transfemoral amputation.
Exclusion Criteria:
Inability to give informed consent
neurological disorder that affects gait
two or more falls within the previous 12 months
currently pregnant (or intend to become pregnant while participating in study)
history of any condition where fatiguing contractions or resisted leg contractions are contraindicated
blood clots in the leg, or any condition in which compression of the thigh or transient ischemia is contraindicated (e.g. open wounds in the leg).
history of hypertension
history of heart failure
Head injury within the previous 6 months
Seizure disorder
Adverse reaction to ultrasound gel
History of thrombosis
History of sickle cell trait
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lindsay Slater, PhD
Phone
3123558965
Email
slaterlv@uic.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lindsay Slater, PhD
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
UIC Physical Therapy Faculty Practice
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60608
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lindsay Slater, PhD
Phone
312-355-8965
Email
slaterlv@uic.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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The Effect of Ischemic Conditioning on Strength and Ambulation in Subjects With PAD
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