Cerebrovascular Accident, Stroke
Conditions
Keywords
Exercise, Rehabilitation, Stroke
Brief summary
Residual neurological deficits from stroke lead to gait inefficiencies, resulting in an extremely high energy cost of movement and contributing to overall disability and lower quality of life. Therefore, interventions targeting movement economy should be developed for those in the chronic phase of stroke recovery. This study is designed to compare the effect of two distinctly different exercise paradigms (a higher-intensity treadmill training program and a lower-intensity group exercise program) on economy of movement during over-ground walking and activities of daily living, as well as the extent to which gains in muscular strength, muscular endurance, and balance predict changes in movement economy.
Interventions
BEHAVIORALHigh-intensity Treadmill Exercise
High-intensity treadmill walking program
BEHAVIORALLow-intensity Lifestyle Intervention
A low-intensity lifestyle intervention targeted towards group exercises incorporating balance, coordination, and strength.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Stroke \> 6 months prior with residual hemiparetic gait in women or men aged 40-85 years. * Completion of all regular post-stroke physical therapy * Adequate language and neurocognitive function to participate in testing and training and to give adequate informed consent. * Able to rise from a chair unaided. * Able to walk 10 meters without human assistance.
Exclusion criteria
* Regular structured aerobic exercise (\> 2x week). * Alcohol consumption \> 3 oz. liquor, or 3 x 4 oz glasses of wine, or 3 x 12 oz. beers per day, by self-report. * Clinical history of * unstable angina, * recent (\< 3 months) myocardial infarction or congestive heart failure (NYHA category II), * hemodynamically significant valvular dysfunction, * Peripheral Arterial Obstructive Disease with claudication, * major orthopedic, chronic pain, or non-stroke neuromuscular disorders restricting exercise, * pulmonary or renal failure, * poorly controlled hypertension (\>190/110), measured on at least two separate occasions * recent hospitalization for severe disease or surgery * severe or global receptive aphasia which confounds reliable testing and training. * Untreated major depression as documented by a Center for Epidemiological Studies-Depression score of \>16 and confirmed by clinical interview. * Pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Economy of Gait | 3 months | Over-ground gait economy measured using a portable metabolic monitoring system, K4b2 during a 6 minute walk, with subjects walking at their comfortable self-selected walking speed while open circuit spirometry collects break-by-break data. The K4b2 consists of a small battery pack and portable gas analyser (weighing less than 1 kg) that participants wear on their chest. Attached to the portable system is a flexible rubber facemask with flowmeter used for breath-by-breath analysis. The mean rate of oxygen consumption (VO2) will be calculated based on the final 3 minutes of a 6-minute walk under steady state oxygen consumption conditions. A 6 minute walk is a distance most representative of community-based ambulatory capacity and is a sensitive outcome measure in exercise studies in chronic stroke subjects. The higher the VO2 used during the 6 minute walk, represents a less efficient economy of gait. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Muscular Strength | 3 months | Strength measured by torque of isokinetic maximal concentric knee extensor volitional contractions of paretic and non-paretic leg at multiple angular velocities (30, 90, and 120°/sec). The higher the number the higher the muscular strength. Also performed on resistance equipment for both the Leg Press and Leg Extension. The higher the number the stronger a person is. |
| Muscular Endurance | 3 months | Muscular endurance performed on Leg Press and assessed by a force transducer, while seated. The longer the amount of time participant can maintain a force the better their muscular endurance. |
| Balance | 3 months | Dynamic Gait Index - another measure related to balance and general function. It includes items of walking while changing speed, turning the head, pivot turning, walking over and around obstacles, and stair climbing. This index ranges from 0 - 24, with 24 representing a high level of balance and general function (the higher the score the better the balance). |
Countries
United States
Participant flow
Recruitment details
Hemiparetic stroke survivors (\>6 months) with residual hemiparetic gait in women/men aged 30-85 years who completed all therapy were recruited. They had to have adequate language and neurocognitive function, give adequate informed consent, able to rise from a chair unaided, and able to walk 10 meters without human assistance.
Participants by arm
| Arm | Count |
|---|---|
| Arm 1: High-Intensity Program High-intensity treadmill-based exercise
High-intensity Treadmill Exercise: High-intensity treadmill walking program | 11 |
| Arm 2: Low-Intensity Program Low-intensity lifestyle intervention (group exercise)
Low-intensity Lifestyle Intervention: A low-intensity lifestyle intervention targeted towards group exercises incorporating balance, coordination, and strength. | 9 |
| Total | 20 |
Baseline characteristics
| Characteristic | Arm 1: High-Intensity Program | Arm 2: Low-Intensity Program | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 3 Participants | 7 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 6 Participants | 13 Participants |
| Age, Continuous | 59.36 years STANDARD_DEVIATION 8.63 | 61.89 years STANDARD_DEVIATION 9.03 | 60.5 years STANDARD_DEVIATION 8.67 |
| BMI | 29.57 kg/m2 STANDARD_DEVIATION 5.73 | 30.34 kg/m2 STANDARD_DEVIATION 7.53 | 29.92 kg/m2 STANDARD_DEVIATION 6.43 |
| Height | 172.79 cm STANDARD_DEVIATION 10.83 | 169.54 cm STANDARD_DEVIATION 11.87 | 171.33 cm STANDARD_DEVIATION 11.13 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 6 Participants | 15 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 3 Participants | 4 Participants |
| Region of Enrollment United States | 11 participants | 9 participants | 20 participants |
| Sex: Female, Male Female | 5 Participants | 6 Participants | 11 Participants |
| Sex: Female, Male Male | 6 Participants | 3 Participants | 9 Participants |
| Weight | 88.92 kg STANDARD_DEVIATION 22.27 | 86.56 kg STANDARD_DEVIATION 19.57 | 87.86 kg STANDARD_DEVIATION 20.59 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 11 | 8 / 9 |
| serious Total, serious adverse events | 1 / 11 | 0 / 9 |
Outcome results
Primary
Economy of Gait
Over-ground gait economy measured using a portable metabolic monitoring system, K4b2 during a 6 minute walk, with subjects walking at their comfortable self-selected walking speed while open circuit spirometry collects break-by-break data. The K4b2 consists of a small battery pack and portable gas analyser (weighing less than 1 kg) that participants wear on their chest. Attached to the portable system is a flexible rubber facemask with flowmeter used for breath-by-breath analysis. The mean rate of oxygen consumption (VO2) will be calculated based on the final 3 minutes of a 6-minute walk under steady state oxygen consumption conditions. A 6 minute walk is a distance most representative of community-based ambulatory capacity and is a sensitive outcome measure in exercise studies in chronic stroke subjects. The higher the VO2 used during the 6 minute walk, represents a less efficient economy of gait.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: High-Intensity Program | Economy of Gait | 13.44 ml/kg/min | Standard Deviation 3.15 |
| Arm 2: Low-Intensity Program | Economy of Gait | 12.67 ml/kg/min | Standard Deviation 3.51 |
Secondary
Balance
Dynamic Gait Index - another measure related to balance and general function. It includes items of walking while changing speed, turning the head, pivot turning, walking over and around obstacles, and stair climbing. This index ranges from 0 - 24, with 24 representing a high level of balance and general function (the higher the score the better the balance).
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: High-Intensity Program | Balance | 17.01 units on a scale | Standard Deviation 4.13 |
| Arm 2: Low-Intensity Program | Balance | 14.22 units on a scale | Standard Deviation 3.56 |
Secondary
Muscular Endurance
Muscular endurance performed on Leg Press and assessed by a force transducer, while seated. The longer the amount of time participant can maintain a force the better their muscular endurance.
Time frame: 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: High-Intensity Program | Muscular Endurance | Leg Press Non-Paretic Leg | 67.55 seconds | Standard Deviation 24.66 |
| Arm 1: High-Intensity Program | Muscular Endurance | Leg Press Paretic Leg | 41.63 seconds | Standard Deviation 22.36 |
| Arm 2: Low-Intensity Program | Muscular Endurance | Leg Press Non-Paretic Leg | 67.22 seconds | Standard Deviation 24.96 |
| Arm 2: Low-Intensity Program | Muscular Endurance | Leg Press Paretic Leg | 40.10 seconds | Standard Deviation 28.12 |
Secondary
Muscular Strength
Strength measured by torque of isokinetic maximal concentric knee extensor volitional contractions of paretic and non-paretic leg at multiple angular velocities (30, 90, and 120°/sec). The higher the number the higher the muscular strength. Also performed on resistance equipment for both the Leg Press and Leg Extension. The higher the number the stronger a person is.
Time frame: 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: High-Intensity Program | Muscular Strength | Leg Extension Non-Paretic Leg | 151.82 newtons (N) | Standard Deviation 53.73 |
| Arm 1: High-Intensity Program | Muscular Strength | Leg Extension Paretic Leg | 101.36 newtons (N) | Standard Deviation 55.64 |
| Arm 1: High-Intensity Program | Muscular Strength | Leg Press Non-Paretic Leg | 491.82 newtons (N) | Standard Deviation 217.42 |
| Arm 1: High-Intensity Program | Muscular Strength | Leg Press Paretic Leg | 371.82 newtons (N) | Standard Deviation 229.78 |
| Arm 2: Low-Intensity Program | Muscular Strength | Leg Press Paretic Leg | 295.56 newtons (N) | Standard Deviation 170.67 |
| Arm 2: Low-Intensity Program | Muscular Strength | Leg Extension Non-Paretic Leg | 113.33 newtons (N) | Standard Deviation 61.24 |
| Arm 2: Low-Intensity Program | Muscular Strength | Leg Press Non-Paretic Leg | 463.33 newtons (N) | Standard Deviation 146.03 |
| Arm 2: Low-Intensity Program | Muscular Strength | Leg Extension Paretic Leg | 70.0 newtons (N) | Standard Deviation 35.18 |