Clinical trial NCT06213272: Combined Exercise and Targeted Therapy for Post-Stroke Reading Deficits
Official title: Improving Reading Competence in Aphasia With Combined Aerobic Exercise and Phono-Motor Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Aphasia
Reading Disorder
Keywords: exercise
stroke
aphasia
reading therapy
phono-motor therapy
aerobic exercise treatment
MRI
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
First posted: 2024-01-19
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to one of the 2 intervention groups: combined aerobic exercise and phono-motor therapy, or combined light stretching and phono-motor therapy. Randomization will be stratified by aphasia severity.
Primary purpose: TREATMENT

Brief summary: The goal of the proposed project is to test the effectiveness of a novel hybrid approach to treatment of reading disorders after stroke, in which exercise training will be used in combination with a targeted reading treatment. This approach is expected to increase cerebral circulation and help to rebuild and strengthen the damaged phonological neural networks. Through this combinatory approach, the study aims to enhance the reading and language improvements seen with existing treatments.

Detailed description: Close to 2.5 million Americans are currently living with post-stroke aphasia, a debilitating communication disorder affecting multiple language modalities. Most stroke survivors with aphasia have acquired reading deficits, which persist chronically and severely limit life participation and autonomy. There is an urgent need for effective treatments grounded in stroke neurobiology which yield robust functional improvements. This project is a randomized controlled trial, which will recruit 70 individuals with chronic left-hemisphere stroke. Participants will complete 40 sessions of targeted reading treatment combined with either 20 minutes of moderate aerobic exercise or light stretching. Participants will undergo 3 Magnetic Resonance Imaging (MRI) scans, administered before the intervention, after the initial exercise session, and after the full course of treatment. They will also complete behavioral testing before and after the intervention. The outcome of this study has the potential to radically change how reading treatments are applied, increasing their effectiveness, and ultimately improving the lives of 2.5 million Americans living with stroke-related aphasia. In addition, it is likely that the results will contribute to the understanding of stroke recovery mechanisms thereby fundamentally advancing the field of neurorehabilitation.

Eligibility criteria: Inclusion Criteria:

* fluent and literate in English prior to stroke
* 1st ever stroke
* more than 3 months post-stroke
* post-stroke reading deficits, defined as reading aloud accuracy \<83% for single words or \<65% for readable nonwords
* living within a 50-mile radius from Kessler Foundation.

Exclusion Criteria:

* contraindication to MRI
* prior neurological disease
* developmental learning or reading disability (i.e., developmental dyslexia)
* contraindication to exercise
* concurrent speech and language therapy

Primary outcomes:
measure: Reading Aloud
timeFrame: Baseline and within 2 weeks of treatment completion (~10 weeks from study onset)
measure: 2 Alternative Forced Choice Computer Tasks
timeFrame: Baseline and within 2 weeks of treatment completion (~10 weeks from study onset)
measure: Reading Comprehension Battery for Aphasia - 2nd edition (RCBA-2)
timeFrame: Baseline and within 2 weeks of treatment completion (~10 weeks from study onset)
measure: Cerebral Blood Flow (CBF)
timeFrame: Baseline, after a single session of acute exercise, and within 2 weeks of treatment completion (~10 weeks from study onset)
measure: Resting State Functional Connectivity (rsFC)
timeFrame: Baseline, after a single session of acute exercise, and within 2 weeks of treatment completion (~10 weeks from study onset)
measure: Task-induced fMRI activation
timeFrame: Baseline and within 2 weeks of treatment completion (~10 weeks from study onset)
Secondary outcomes:
measure: Western Aphasia Battery Revised
timeFrame: Baseline and within 2 weeks of treatment completion (~10 weeks from study onset)
measure: Philadelphia Naming Test (Short)
timeFrame: Baseline and within 2 weeks of treatment completion (~10 weeks from study onset)
Other outcomes:
Locations:
city: West Orange
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
affiliation: Kessler Foundation
name: Olga Boukrina
role: PRINCIPAL_INVESTIGATOR
References: