Depression, Stroke
Conditions
Keywords
stroke, rehabilitation, depression, exercise
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALPower training
high-intensity lower extremity resistance training
BEHAVIORALStretching
upper and lower body range of motion exercises
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* age 50-70 * stroke within the past 6 to 60 months * residual paresis in the lower extremity (Fugl-Meyer LE motor score \<34) * ability to walk without assistance and without an AFO during testing and training at speeds ranging from 0.2-0.8 m/s * no antidepressant medications or no change in doses of psychotropic medication for at least 4 weeks prior to the study (6 weeks if newly initiated medication) * HRSD question #9 regarding suicide \<2; and 7) provision of informed consent.
Exclusion criteria
* Unable to ambulate at least 150 feet prior to stroke, or experienced intermittent claudication while walking * history of congestive heart failure, unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during ADL's * History of COPD or oxygen dependence * Preexisting neurological disorders, dementia or previous stroke * History of major head trauma * Legal blindness or severe visual impairment * history of psychosis or other Axis I disorder that is primary * Life expectancy \<1 yr. * Severe arthritis or other problems that limit passive ROM * History of DVT or pulmonary embolism within 6 months * Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions * Severe hypertension with systolic \>200 mmHg and diastolic \>110 mmHg at rest * attempt of suicide in the last 2 years or at suicidal risk assessed by SCID interview * History of seizures or currently prescribed anti-seizure medications * Current enrollment in a clinical trial to enhance motor recovery * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mean Score of Depression as Assessed by the Hamilton Rating Scale for Depression | Visit 1 through visit 24 (up to 12 weeks) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Self Selected Walking Speed | Visit 1 through visit 24 (up to 12 weeks) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| POWER Training - Depressed high velocity strength training in depressed individuals
Power training: high-intensity lower extremity resistance training | 19 |
| Stretching Upper and lower body range of motion exercises
Stretching: upper and lower body range of motion exercises | 12 |
| POWER Training - Non-Depressed high velocity strength training in non-depressed individuals
Power training: high-intensity lower extremity resistance training | 17 |
| Total | 48 |
Baseline characteristics
| Characteristic | POWER Training - Depressed | Stretching | POWER Training - Non-Depressed | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 4 Participants | 9 Participants | 16 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 8 Participants | 8 Participants | 32 Participants |
| Age, Continuous | 51.37 years STANDARD_DEVIATION 10.82 | 57.83 years STANDARD_DEVIATION 12.25 | 62.59 years STANDARD_DEVIATION 9.8 | 56.96 years STANDARD_DEVIATION 11.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 7 Participants | 5 Participants | 18 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 12 Participants | 5 Participants | 12 Participants | 29 Participants |
| Sex: Female, Male Female | 10 Participants | 8 Participants | 4 Participants | 22 Participants |
| Sex: Female, Male Male | 9 Participants | 4 Participants | 13 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 12 | 0 / 17 |
| other Total, other adverse events | 2 / 19 | 0 / 12 | 1 / 17 |
| serious Total, serious adverse events | 0 / 19 | 0 / 12 | 0 / 17 |
Outcome results
Primary
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| POWER Training - Depressed | Change in Mean Score of Depression as Assessed by the Hamilton Rating Scale for Depression | 5.20 units on a scale | Standard Deviation 4.31 |
| Stretching | Change in Mean Score of Depression as Assessed by the Hamilton Rating Scale for Depression | 2.17 units on a scale | Standard Deviation 4.72 |
| POWER Training - Non-Depressed | Change in Mean Score of Depression as Assessed by the Hamilton Rating Scale for Depression | 0.14 units on a scale | Standard Deviation 2.83 |
Secondary
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| POWER Training - Depressed | Change in Self Selected Walking Speed | 0.08 meters per second | Standard Deviation 0.02 |
| Stretching | Change in Self Selected Walking Speed | 0.06 meters per second | Standard Deviation 0.02 |
| POWER Training - Non-Depressed | Change in Self Selected Walking Speed | 0.21 meters per second | Standard Deviation 0.06 |