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Behavioural Intervention

High-intensity physical exercise for Aphasia

N/A
Recruiting
Led By Maria Ivanova, PhD
Research Sponsored by University of California, Berkeley
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Between the ages of 18 and 80
Aphasia following left hemisphere ischemic or hemorrhagic stroke
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after the intervention (3rd week for the control intervention and 9th week for the experimental intervention)
Awards & highlights

Study Summary

This trial wants to see if a high-intensity exercise program can be done by people with post-stroke aphasia. They want to know if stroke survivors with aphasia can do a long exercise program

Who is the study for?
This trial is for individuals aged 18-80 who have had a stroke resulting in aphasia, are at least 6 months post-stroke, spoke English proficiently before the stroke, and have completed at least 8 years of education. They must be able to walk on their own or with a cane and cleared by a doctor for physical exercise. Those with dementia, other neurological illnesses besides stroke, substance abuse issues, significant visual/hearing disabilities, or uncontrolled heart/lung/metabolic conditions cannot participate.Check my eligibility
What is being tested?
The study is testing whether people with post-stroke aphasia can stick to an intense workout program and if it helps improve their fitness level as well as cognitive and language abilities. Participants will either do low-intensity exercises (as a control group) or high-intensity workouts (as the target intervention).See study design
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects from participating in physical exercise programs may include muscle soreness, fatigue, joint pain or injury risk; however these depend on individual health status and should be monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 80 years old.
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I have difficulty speaking due to a stroke in the left side of my brain.
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I can walk on my own, but I may use a cane.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after the intervention (3rd week for the control intervention and 9th week for the experimental intervention)
This trial's timeline: 3 weeks for screening, Varies for treatment, and after the intervention (3rd week for the control intervention and 9th week for the experimental intervention) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change on the Western Aphasia Battery (WAB) - Aphasia Quotient
Secondary outcome measures
Attendance
Change in Gait Speed
Change on the 2-minute Step Test
+4 more
Other outcome measures
Change on the Curtiss-Yamada Comprehensive Language Evaluation - Revised (CYCLE-R)
Change on the Philadelphia Naming Test (PNT)
Changes on the Center for Epidemiological Studies Depression Scale (CES-D)
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: High-intensity physical exerciseExperimental Treatment1 Intervention
The participants will take part in a high-intensity Aphasia Physical EXercise (APEX) intervention designed specifically for individuals with chronic post-stroke aphasia for 8 weeks.
Group II: Low-intensity physical exerciseActive Control1 Intervention
The participants will participate in a low-intensity non-aerobic exercise program for 2 weeks.

Find a Location

Who is running the clinical trial?

University of California, BerkeleyLead Sponsor
181 Previous Clinical Trials
721,144 Total Patients Enrolled
California State University, East BayOTHER
1 Previous Clinical Trials
28 Total Patients Enrolled
1 Trials studying Aphasia
28 Patients Enrolled for Aphasia
University of San FranciscoOTHER
9 Previous Clinical Trials
1,271 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of individuals who have been granted admission to participate in this clinical study?

"Indeed, the data available on clinicaltrials.gov confirms that this study is currently accepting participants. The trial was initially posted on December 12th, 2023 and last updated on December 14th, 2023. A total of 12 patients will be enrolled in this clinical trial across four different sites."

Answered by AI

Is the clinical trial open to individuals aged 70 and above?

"This clinical trial is specifically seeking participants between the ages of 18 and 80. However, there are also separate trials available for patients under 18 (6 trials) as well as those over 65 (100 trials)."

Answered by AI

Are researchers currently recruiting participants for this ongoing medical study?

"Indeed, clinicaltrials.gov confirms that this research study is actively seeking potential participants. The trial was initially posted on December 12th, 2023 and has been recently updated on December 14th, 2023."

Answered by AI
~8 spots leftby Dec 2024