Clinical trial NCT06185023: Effects of High-intensity Exercise Training on Physical Fitness, Cognition, Language in Post-stroke Aphasia
Official title: Exercising Language: Behavioral and Neurophysiological Changes After High-intensity Exercise Training in Post-stroke Aphasia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Aphasia, Acquired
Aphasia
Aphasia, Fluent
Aphasia Non Fluent
Keywords: aphasia
physical exercise
high intensity interval training
cognition
physical fitness
balance
Lead sponsor: University of California, Berkeley
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
name: University of San Francisco
name: California State University, East Bay
First posted: 2023-12-29
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: As this is a feasibility study, participants can choose to participate in just one or both types of physical exercise interventions.
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to establish the feasibility and fidelity of a high-intensity exercise program for individuals with post-stroke aphasia. The main questions it aims to answer are:

* Is it feasible for stroke survivors with aphasia to participate in a long in-person physical exercise program?
* Does participation in a physical exercise program lead to physical fitness, cognitive, language and/or psychological changes?

Participants can take part in two different physical exercise interventions:

* Low intensity intervention (control intervention);
* High-intensity physical exercise intervention (target intervention).


Eligibility criteria: Inclusion Criteria:

* aphasia following single or multiple ischemic or hemorrhagic stroke;
* at least 6 months from the last stroke;
* proficient in English before the stroke;
* at least 8 years of education;
* between the ages of 18 and 80;
* independent with ambulation without a device (single-point cane accepted);
* medically stable with no contraindications to participate in regular physical exercise as determined by the patient's own primary care provider or other treating provider.

Exclusion Criteria:

* prior history of dementia, neurologic illness (other than stroke), or substance abuse;
* significant visual or hearing disabilities (e.g., neglect, uncorrected visual or hearing loss) that interfere with testing;
* per self-report uncontrolled cardiorespiratory and/or metabolic disorders incompatible with exercise.

Primary outcomes:
measure: Change on the Western Aphasia Battery (WAB) - Aphasia Quotient
timeFrame: Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm)
Secondary outcomes:
measure: Changes in Maximal Aerobic Capacity
timeFrame: Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm)
measure: Attendance
timeFrame: After the intervention (3rd week for the control intervention and 9th week for the experimental intervention)
measure: Change on the 30-second chair stands
timeFrame: Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm)
measure: Change on the 2-minute Step Test
timeFrame: Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm)
measure: Change on the Timed Up-and-Go Test
timeFrame: Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm)
measure: Change on the Functional Reach Test
timeFrame: Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm)
measure: Change in Gait Speed
timeFrame: Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm)
Other outcomes:
measure: Change on the Philadelphia Naming Test (PNT)
timeFrame: Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm)
measure: Change on the Curtiss-Yamada Comprehensive Language Evaluation - Revised (CYCLE-R)
timeFrame: Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm)
measure: Changes on the Center for Epidemiological Studies Depression Scale (CES-D)
timeFrame: Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm)
measure: Changes on the General Anxiety Disorder scale (GAD-7)
timeFrame: Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm)
measure: Changes on the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm)
measure: Changes on the Stroke and Aphasia Quality of Life Scale - 39 (SAQOL-39)
timeFrame: Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm)
measure: Change on the Modified Rankin Scale (MRS)
timeFrame: Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm)
measure: Changes on the National Institute of Health Stroke Scale (NIHSS)
timeFrame: Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm)
measure: Changes on the Fugl-Meyer Assessment, Upper Extremity portion (FMA-UE)
timeFrame: Baseline and immediately after the intervention (3rd week for the low-intensity arm and 9th week for the high-intensity arm)
Locations:
city: Berkeley
country: United States
facility: University of California Berkeley
state: California
city: Hayward
country: United States
facility: California State University East Bay
state: California
city: San Francisco
country: United States
facility: University of San Francisco
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, Berkeley
name: Maria Ivanova, PhD
role: PRINCIPAL_INVESTIGATOR
References: