Trial Outcomes & Findings for Exercise as an Adjuvant to Aphasia Therapy (NCT NCT01113879)

Last Updated: 2019-07-22

Results Overview

Tau-U effect sizes of \<0.20 were considered small; 0.20 to \<0.60 moderate; 0.60 to \<0.80 large, and \>=0.80 very large. Weighted Tau-U averages in exercise participants and stretching participants were calculated in each block using an online web-based calculator (http://www.singleresearch.org/calculators/tau-u). In the present analysis, any baseline trends over 0.10 were adjusted.

Recruitment status

COMPLETED

Study phase

Target enrollment

9 participants

Primary outcome timeframe

administered before and after each of two, two week aphasia therapy blocks

Results posted on

2019-07-22

Participant Flow

Participant milestones

Participant milestones
Measure	Aphasia Therapy Alone, Then With Exercise Aphasia therapy for anomia: The treatment is a traditional lexical/semantic stimulation approach during which subjects will attempt to name drawings of objects. Aerobic exercise: An aerobic exercise intervention will target cardiorespiratory fitness by progressing from 50-70% of the participants' maximum heart rate. Following assessment and baseline procedures, participants completed 2 therapy periods: Block 1 was aphasia therapy alone, and Block 2 was aphasia therapy plus an aerobic exercise or stretching adjuvant.	Aphasia Therapy Alone, Then With Stretching Aphasia therapy for anomia: The treatment is a traditional lexical/semantic stimulation approach during which subjects will attempt to name drawings of objects. Stretching: Stretching will occur for 50 minutes a day, three days/week for 12 weeks.
Period 1: Block 1 STARTED	7	2
Period 1: Block 1 COMPLETED	5	2
Period 1: Block 1 NOT COMPLETED	2	0
Period 2: Block 2 STARTED	5	2
Period 2: Block 2 COMPLETED	5	2
Period 2: Block 2 NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Aphasia Therapy Alone, Then With Exercise Aphasia therapy for anomia: The treatment is a traditional lexical/semantic stimulation approach during which subjects will attempt to name drawings of objects. Aerobic exercise: An aerobic exercise intervention will target cardiorespiratory fitness by progressing from 50-70% of the participants' maximum heart rate. Following assessment and baseline procedures, participants completed 2 therapy periods: Block 1 was aphasia therapy alone, and Block 2 was aphasia therapy plus an aerobic exercise or stretching adjuvant.	Aphasia Therapy Alone, Then With Stretching Aphasia therapy for anomia: The treatment is a traditional lexical/semantic stimulation approach during which subjects will attempt to name drawings of objects. Stretching: Stretching will occur for 50 minutes a day, three days/week for 12 weeks.
Period 1: Block 1 Withdrawal by Subject	2	0

Baseline Characteristics

Exercise as an Adjuvant to Aphasia Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aphasia Therapy With an Exercise Adjuvant n=7 Participants Aphasia therapy for anomia: The treatment is a traditional lexical/semantic stimulation approach during which subjects will attempt to name drawings of objects. Aerobic exercise: An aerobic exercise intervention will target cardiorespiratory fitness by progressing from 50-70% of the participants' maximum heart rate.	Aphasia Therapy With a Stretching Adjuvant n=2 Participants Aphasia therapy for anomia: The treatment is a traditional lexical/semantic stimulation approach during which subjects will attempt to name drawings of objects. Stretching: Stretching will occur for 50 minutes a day, three days/week for 12 weeks.	Total n=9 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	63.2 years STANDARD_DEVIATION 12.5 • n=5 Participants	44.5 years STANDARD_DEVIATION 10.6 • n=7 Participants	57.9 years STANDARD_DEVIATION 14.4 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	7 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants
Boston Naming Test	20.6 units on a scale n=5 Participants	21.5 units on a scale n=7 Participants	20.9 units on a scale n=5 Participants
Western Aphasia Battery	58.6 units on a scale n=5 Participants	60.1 units on a scale n=7 Participants	59 units on a scale n=5 Participants

PRIMARY outcome

Timeframe: administered before and after each of two, two week aphasia therapy blocks

Outcome measures

Outcome measures
Measure	Aphasia Therapy With an Exercise Adjuvant n=5 Participants Aerobic exercise: An aerobic exercise intervention will target cardiorespiratory fitness by progressing from 50-70% of the participants' maximum heart rate.	Aphasia Therapy With a Stretching Adjuvant n=2 Participants Stretching: Stretching will occur for 50 minutes a day, three days/week for 12 weeks.
Change in Picture Naming Abilities as Measured by Tau U Effect Size Weighted Means Weighted Tau U for Block 1	0.83 Tau U effect size weighted mean Interval 0.67 to 1.0	0.75 Tau U effect size weighted mean Interval 0.49 to 1.0
Change in Picture Naming Abilities as Measured by Tau U Effect Size Weighted Means Weighted Tau U for Block 2	0.88 Tau U effect size weighted mean Interval 0.71 to 1.0	0.77 Tau U effect size weighted mean Interval 0.5 to 1.0

SECONDARY outcome

Timeframe: six samples collected over a 16 week period

Population: Complete BDNF datasets from 5 of the 7 participants who completed the study were available. BDNF data from the remaining two participants were not collected due to the PI and study team moving locations and no longer having access to the facilities.

The baseline BDNF levels in participants (ie, the 2 measures prior to the exercise or stretching interventions) showed a great deal of intraparticipant variation. Hence, in an attempt to minimize the intraparticipant variability, we calculated the mean values from samples 1 and 2 to obtain a baseline BDNF measure, samples 3 and 4 to obtain a BDNF measure in the first 6 weeks of aerobic exercise or stretching, and samples 5 and 6 to obtain a measure in the last 6 weeks of the exercise or stretching intervention.

Outcome measures

Outcome measures
Measure	Aphasia Therapy With an Exercise Adjuvant n=4 Participants Aerobic exercise: An aerobic exercise intervention will target cardiorespiratory fitness by progressing from 50-70% of the participants' maximum heart rate.	Aphasia Therapy With a Stretching Adjuvant n=1 Participants Stretching: Stretching will occur for 50 minutes a day, three days/week for 12 weeks.
Change in Serum Brain-derived Neurotrophic Factor (BDNF) Levels With Exercise BDNF increased from first 6 weeks to last 6 weeks	4 participants	0 participants
Change in Serum Brain-derived Neurotrophic Factor (BDNF) Levels With Exercise BDNF increased from baseline to six weeks adjuvant	0 participants	1 participants
Change in Serum Brain-derived Neurotrophic Factor (BDNF) Levels With Exercise BDNF decreased from baseline to six week adjuvant	4 participants	0 participants
Change in Serum Brain-derived Neurotrophic Factor (BDNF) Levels With Exercise BDNF decreased from first 6 weeks to last 6 weeks	0 participants	1 participants

Adverse Events

Aphasia Therapy With an Exercise Adjuvant

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Aphasia Therapy With a Stretching Adjuvant

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Stacy Harnish

The Ohio State University

Phone: 614-688-1471

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place