Trial Outcomes & Findings for Task-oriented Training for Stroke: Impact on Function Mobility (NCT NCT01322607)

NCT ID: NCT01322607

Last Updated: 2016-04-06

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

3 months

Results posted on

2016-04-06

Participant Flow

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.

Participant milestones

Participant milestones
Measure
Arm 1: High-Intensity Program
High-intensity treadmill-based exercise High-intensity Treadmill Exercise: High-intensity treadmill walking program
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.
Overall Study
STARTED
11
9
Overall Study
COMPLETED
10
9
Overall Study
NOT COMPLETED
1
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Task-oriented Training for Stroke: Impact on Function Mobility

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Arm 1: High-Intensity Program
n=11 Participants
High-intensity treadmill-based exercise High-intensity Treadmill Exercise: High-intensity treadmill walking program
Arm 2: Low-Intensity Program
n=9 Participants
Low-intensity lifestyle intervention (group exercise) Low-intensity Lifestyle Intervention: A low-intensity lifestyle intervention targeted towards group exercises incorporating balance, coordination, and strength.
Total
n=20 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Age, Categorical
Between 18 and 65 years
7 Participants
n=99 Participants
6 Participants
n=107 Participants
13 Participants
n=206 Participants
Age, Categorical
>=65 years
4 Participants
n=99 Participants
3 Participants
n=107 Participants
7 Participants
n=206 Participants
Age, Continuous
59.36 years
STANDARD_DEVIATION 8.63 • n=99 Participants
61.89 years
STANDARD_DEVIATION 9.03 • n=107 Participants
60.5 years
STANDARD_DEVIATION 8.67 • n=206 Participants
Sex: Female, Male
Female
5 Participants
n=99 Participants
6 Participants
n=107 Participants
11 Participants
n=206 Participants
Sex: Female, Male
Male
6 Participants
n=99 Participants
3 Participants
n=107 Participants
9 Participants
n=206 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Asian
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants
n=99 Participants
0 Participants
n=107 Participants
1 Participants
n=206 Participants
Race (NIH/OMB)
Black or African American
9 Participants
n=99 Participants
6 Participants
n=107 Participants
15 Participants
n=206 Participants
Race (NIH/OMB)
White
1 Participants
n=99 Participants
3 Participants
n=107 Participants
4 Participants
n=206 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Region of Enrollment
United States
11 participants
n=99 Participants
9 participants
n=107 Participants
20 participants
n=206 Participants
BMI
29.57 kg/m2
STANDARD_DEVIATION 5.73 • n=99 Participants
30.34 kg/m2
STANDARD_DEVIATION 7.53 • n=107 Participants
29.92 kg/m2
STANDARD_DEVIATION 6.43 • n=206 Participants
Weight
88.92 kg
STANDARD_DEVIATION 22.27 • n=99 Participants
86.56 kg
STANDARD_DEVIATION 19.57 • n=107 Participants
87.86 kg
STANDARD_DEVIATION 20.59 • n=206 Participants
Height
172.79 cm
STANDARD_DEVIATION 10.83 • n=99 Participants
169.54 cm
STANDARD_DEVIATION 11.87 • n=107 Participants
171.33 cm
STANDARD_DEVIATION 11.13 • n=206 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Arm 1: High-Intensity Program
n=10 Participants
High-intensity treadmill-based exercise High-intensity Treadmill Exercise: High-intensity treadmill walking program
Arm 2: Low-Intensity Program
n=9 Participants
Low-intensity lifestyle intervention (group exercise) Low-intensity Lifestyle Intervention: A low-intensity lifestyle intervention targeted towards group exercises incorporating balance, coordination, and strength.
Economy of Gait
13.44 ml/kg/min
Standard Deviation 3.15
12.67 ml/kg/min
Standard Deviation 3.51

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Arm 1: High-Intensity Program
n=10 Participants
High-intensity treadmill-based exercise High-intensity Treadmill Exercise: High-intensity treadmill walking program
Arm 2: Low-Intensity Program
n=9 Participants
Low-intensity lifestyle intervention (group exercise) Low-intensity Lifestyle Intervention: A low-intensity lifestyle intervention targeted towards group exercises incorporating balance, coordination, and strength.
Muscular Strength
Leg Extension Non-Paretic Leg
151.82 newtons (N)
Standard Deviation 53.73
113.33 newtons (N)
Standard Deviation 61.24
Muscular Strength
Leg Extension Paretic Leg
101.36 newtons (N)
Standard Deviation 55.64
70.0 newtons (N)
Standard Deviation 35.18
Muscular Strength
Leg Press Non-Paretic Leg
491.82 newtons (N)
Standard Deviation 217.42
463.33 newtons (N)
Standard Deviation 146.03
Muscular Strength
Leg Press Paretic Leg
371.82 newtons (N)
Standard Deviation 229.78
295.56 newtons (N)
Standard Deviation 170.67

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Arm 1: High-Intensity Program
n=10 Participants
High-intensity treadmill-based exercise High-intensity Treadmill Exercise: High-intensity treadmill walking program
Arm 2: Low-Intensity Program
n=9 Participants
Low-intensity lifestyle intervention (group exercise) Low-intensity Lifestyle Intervention: A low-intensity lifestyle intervention targeted towards group exercises incorporating balance, coordination, and strength.
Muscular Endurance
Leg Press Non-Paretic Leg
67.55 seconds
Standard Deviation 24.66
67.22 seconds
Standard Deviation 24.96
Muscular Endurance
Leg Press Paretic Leg
41.63 seconds
Standard Deviation 22.36
40.10 seconds
Standard Deviation 28.12

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure
Arm 1: High-Intensity Program
n=11 Participants
High-intensity treadmill-based exercise High-intensity Treadmill Exercise: High-intensity treadmill walking program
Arm 2: Low-Intensity Program
n=9 Participants
Low-intensity lifestyle intervention (group exercise) Low-intensity Lifestyle Intervention: A low-intensity lifestyle intervention targeted towards group exercises incorporating balance, coordination, and strength.
Balance
17.01 units on a scale
Standard Deviation 4.13
14.22 units on a scale
Standard Deviation 3.56

Adverse Events

Arm 1: High-Intensity Program

Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths

Arm 2: Low-Intensity Program

Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Arm 1: High-Intensity Program
n=11 participants at risk
High-intensity treadmill-based exercise High-intensity Treadmill Exercise: High-intensity treadmill walking program
Arm 2: Low-Intensity Program
n=9 participants at risk
Low-intensity lifestyle intervention (group exercise) Low-intensity Lifestyle Intervention: A low-intensity lifestyle intervention targeted towards group exercises incorporating balance, coordination, and strength.
Gastrointestinal disorders
Esophagitis/Upper Gastrointestinal Bleed
9.1%
1/11 • Number of events 1 • Adverse event information was obtained for participants for the duration of their time in this study (0-3months)
0.00%
0/9 • Adverse event information was obtained for participants for the duration of their time in this study (0-3months)

Other adverse events

Other adverse events
Measure
Arm 1: High-Intensity Program
n=11 participants at risk
High-intensity treadmill-based exercise High-intensity Treadmill Exercise: High-intensity treadmill walking program
Arm 2: Low-Intensity Program
n=9 participants at risk
Low-intensity lifestyle intervention (group exercise) Low-intensity Lifestyle Intervention: A low-intensity lifestyle intervention targeted towards group exercises incorporating balance, coordination, and strength.
General disorders
Fall
54.5%
6/11 • Number of events 12 • Adverse event information was obtained for participants for the duration of their time in this study (0-3months)
88.9%
8/9 • Number of events 14 • Adverse event information was obtained for participants for the duration of their time in this study (0-3months)

Additional Information

Research Specilist

Baltimore VA Medical Center (VAHMCS)

Phone: 410-605-7156

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place