A Phase 2 interventional study of Power training and Stretching in Stroke and Depression, sponsored by Medical University of South Carolina. Completed at 1 site in United States. Open to participants aged 50 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-04-24.
Sponsored by Medical University of South Carolina · Phase 2, Interventional, and Treatment
The investigators will study the effects of a 12 week strength training program on individuals who have had a stroke and are depressed to see if this type of exercise training helps treat depression and improves walking function. Our goal is to use the information collected in this study to help design treatments for people who have had a stroke that will help with many of the common consequences of stroke, including depression, muscle weakness and slow walking. Progress toward overcoming some of these issues would be incredibly valuable to any person who has had a stroke and their families.
Depression is the most common neuropsychiatric manifestation following stroke and current treatments are largely ineffective. Depression has both direct and indirect effects on response to rehabilitation, thus subjects with post-stroke depression (PSD) are routinely excluded from clinical trials and treatment options are extremely limited. The investigators propose to determine the impact of a novel, high-intensity resistance training program, Post-stroke Optimization of Walking using Explosive Resistance (POWER) training, on post-stroke depressive symptoms. Further, the investiators will determine if depression limits training-induced improvements in muscular and locomotor function. This project is based on the premise that depression negatively affects the potential for neuroplastic changes to occur in response to treatment such that rehabilitation may not produce the same adaptations that it does in non-depressed individuals. The investigators propose that effective treatment for PSD would result in a virtuous cycle where reducing depression enhances neuroplastic changes, thereby facilitating functional gains. That is, effectively treating depression will make the individual better able to recover from stroke. Furthermore, in addition to its beneficial effects on depression, POWER training is known to improve post-stroke walking, thus providing an attractive option for treating depression as well as an established vehicle to study the effects of PSD on response to rehabilitation. The experiments proposed as part of this project are designed to address critical questions related to 1) the effects of POWER training on depressive symptoms; 2) the potential for PSD to limit improvements following training; and 3) the interaction between improvements in depression and increases in walking function. Successful completion of this project will provide a foundation for larger scale trials to determine dosing parameters as well as establish therapeutic effectiveness of POWER training on post-stroke depression as well as identify the mechanisms that may be responsible for the changes that occur in response to treatment.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 48 is close to the median of 50 across 5,369 interventional studies indexed under Stroke.
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Of its 128 completed or terminated interventional studies of FDA-regulated products, 101 (79%) have results posted.
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Exclusion Criteria:
high velocity strength training
Behavioral: Power training
Upper and lower body range of motion exercises
Behavioral: Stretching
high-intensity lower extremity resistance training
upper and lower body range of motion exercises
Change in Mean Score of Depression as Assessed by the Hamilton Rating Scale for Depression
The HAM-D is a clinician-rated scale with scores based on clinical interview and family report. It addresses both somatic and psychological symptoms of depression. Items are rated on either a 5-point scale (0 to 4) or 3-point scale (0 to 2), where higher scores represent increasing severity of depression. The scores of the 17 items are summed to obtain a total score (minimum score: 0, maximum score: 52).
Time frame: Visit 1 through visit 24 (up to 12 weeks)
Change in Self Selected Walking Speed
Subjects will walk on a 14-ft. long gait mat (GaitRite) to measure self-selected and fastest comfortable walking speed and other spatiotemporal parameters of walking. Subjects will be permitted a practice trial, and then be asked to complete three trials at each speed. For all trials, subjects will wear their own shoes and be asked to walk without an assistive device or ankle-foot orthosis.
Time frame: Visit 1 through visit 24 (up to 12 weeks)
| Milestone | POWER Training - Depressed | Stretching | POWER Training - Non-Depressed |
|---|---|---|---|
| Started | 19 | 12 | 17 |
| Completed | 12 | 9 | 15 |
| Not completed | 7 | 3 | 2 |
The HAM-D is a clinician-rated scale with scores based on clinical interview and family report. It addresses both somatic and psychological symptoms of depression. Items are rated on either a 5-point scale (0 to 4) or 3-point scale (0 to 2), where higher scores represent increasing severity of depression. The scores of the 17 items are summed to obtain a total score (minimum score: 0, maximum score: 52).
| units on a scale | POWER Training - Depressed | Stretching | POWER Training - Non-Depressed |
|---|---|---|---|
| Change in Mean Score of Depression as Assessed by the Hamilton Rating Scale for Depression | 5.20 ± 4.31 | 2.17 ± 4.72 | 0.14 ± 2.83 |
Subjects will walk on a 14-ft. long gait mat (GaitRite) to measure self-selected and fastest comfortable walking speed and other spatiotemporal parameters of walking. Subjects will be permitted a practice trial, and then be asked to complete three trials at each speed. For all trials, subjects will wear their own shoes and be asked to walk without an assistive device or ankle-foot orthosis.
| meters per second | POWER Training - Depressed | Stretching | POWER Training - Non-Depressed |
|---|---|---|---|
| Change in Self Selected Walking Speed | 0.08 ± 0.02 | 0.06 ± 0.02 | 0.21 ± 0.06 |
Collected over throughout the 12 week training intervention. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| POWER Training - Depressed | 0/19 (0%) | 0/19 (0%) | 2/19 (10.5%) |
| Stretching | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| POWER Training - Non-Depressed | 0/17 (0%) | 0/17 (0%) | 1/17 (5.9%) |
| Event | POWER Training - Depressed | Stretching | POWER Training - Non-Depressed |
|---|---|---|---|
| mild injury (sprain/contusion)Musculoskeletal and connective tissue disorders | 2/19 | 0/12 | 1/17 |
| Age, Categorical(Participants) | POWER Training - Depressed | Stretching | POWER Training - Non-Depressed | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 16 | 8 | 8 | 32 |
| >=65 years | 3 | 4 | 9 | 16 |
| Age, Continuous(years) | POWER Training - Depressed | Stretching | POWER Training - Non-Depressed | Total |
|---|---|---|---|---|
| Mean | 51.37 ± 10.82 | 57.83 ± 12.25 | 62.59 ± 9.8 | 56.96 ± 11.70 |
| Sex: Female, Male(Participants) | POWER Training - Depressed | Stretching | POWER Training - Non-Depressed | Total |
|---|---|---|---|---|
| Female | 10 | 8 | 4 | 22 |
| Male | 9 | 4 | 13 | 26 |
| Race (NIH/OMB)(Participants) | POWER Training - Depressed | Stretching | POWER Training - Non-Depressed | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 1 | 0 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 6 | 7 | 5 | 18 |
| White | 12 | 5 | 12 | 29 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
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Medical University of South Carolina