Trial Outcomes & Findings for Skeletal Muscle Properties and the Metabolic Cost of Walking Post-stroke (NCT NCT00721357)

NCT ID: NCT00721357

Last Updated: 2019-03-18

Results Overview

Amount of oxygen consumed during walking at self-selected speed normalized to speed

• Recruitment status: COMPLETED
• Target enrollment: 30 participants
• Primary outcome timeframe: within one week of enrollment
• Results posted on: 2019-03-18

Participant Flow

Participant milestones

Measure	Stroke those with condition Treadmill walking: Subjects will perform treadmill walking at a self-selected velocity Magnetic resonance spectroscopy: Muscle oxidative capacity will be assessed via Magnetic resonance spectroscopy (31P-MRS)	Control those without condition Treadmill walking: Subjects will perform treadmill walking at a self-selected velocity Magnetic resonance spectroscopy: Muscle oxidative capacity will be assessed via Magnetic resonance spectroscopy (31P-MRS)
Overall Study STARTED	15	15
Overall Study COMPLETED	15	15
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Skeletal Muscle Properties and the Metabolic Cost of Walking Post-stroke

Baseline characteristics by cohort

Measure	Stroke n=15 Participants those with condition Treadmill walking: Subjects will perform treadmill walking at a self-selected velocity Magnetic resonance spectroscopy: Muscle oxidative capacity will be assessed via Magnetic resonance spectroscopy (31P-MRS)	Control n=15 Participants those without condition Treadmill walking: Subjects will perform treadmill walking at a self-selected velocity Magnetic resonance spectroscopy: Muscle oxidative capacity will be assessed via Magnetic resonance spectroscopy (31P-MRS)	Total n=30 Participants Total of all reporting groups
Age, Continuous	57.3 years STANDARD_DEVIATION 9.2 • n=5 Participants	54.2 years STANDARD_DEVIATION 5.1 • n=7 Participants	57.3 years STANDARD_DEVIATION 9.2 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
walking speed	0.57 meters per second STANDARD_DEVIATION 0.23 • n=5 Participants	1.17 meters per second STANDARD_DEVIATION 0.15 • n=7 Participants	0.87 meters per second STANDARD_DEVIATION 0.20 • n=5 Participants
muscle oxidative capacity	5.1 millimolar inorganic phosphate STANDARD_DEVIATION 0.87 • n=5 Participants	3.2 millimolar inorganic phosphate STANDARD_DEVIATION 0.56 • n=7 Participants	4.2 millimolar inorganic phosphate STANDARD_DEVIATION 0.72 • n=5 Participants
muscle mechanical energy expenditure	374 Joules per kg STANDARD_DEVIATION 161 • n=5 Participants	242 Joules per kg STANDARD_DEVIATION 66 • n=7 Participants	309 Joules per kg STANDARD_DEVIATION 112 • n=5 Participants

PRIMARY outcome

Timeframe: within one week of enrollment

Amount of oxygen consumed during walking at self-selected speed normalized to speed

Outcome measures

Measure	Stroke n=15 Participants those with condition Treadmill walking: Subjects will perform treadmill walking at a self-selected velocity Magnetic resonance spectroscopy: Muscle oxidative capacity will be assessed via Magnetic resonance spectroscopy (31P-MRS)	Control n=15 Participants those without condition Treadmill walking: Subjects will perform treadmill walking at a self-selected velocity Magnetic resonance spectroscopy: Muscle oxidative capacity will be assessed via Magnetic resonance spectroscopy (31P-MRS)
Oxygen Consumption During Walking	11.25 ml/kg/min Standard Deviation .76	4.46 ml/kg/min Standard Deviation .27

SECONDARY outcome

Timeframe: one time measure within one week of enrollment

Population: Individuals following stroke and matched non-stroke individuals. Sample size differences reflect the inability of some subjects to walk on the instrumented treadmill at speeds necessary to collect the kinematic data.

mechanical work done by lower extremity joints

Outcome measures

Measure	Stroke n=12 Participants those with condition Treadmill walking: Subjects will perform treadmill walking at a self-selected velocity Magnetic resonance spectroscopy: Muscle oxidative capacity will be assessed via Magnetic resonance spectroscopy (31P-MRS)	Control n=12 Participants those without condition Treadmill walking: Subjects will perform treadmill walking at a self-selected velocity Magnetic resonance spectroscopy: Muscle oxidative capacity will be assessed via Magnetic resonance spectroscopy (31P-MRS)
Muscle Mechanical Energy Expenditure	5.66 joules per kilogram meter Standard Deviation 1.89	3.61 joules per kilogram meter Standard Deviation 1.42

SECONDARY outcome

Timeframe: within one week of enrollment

Population: Sample size differences reflect the fact that some subjects are either incompatible with imaging procedures because they are either unable to lie still for the time necessary to collect these data, are claustrophobic or have metal somewhere in their body that prevents imaging.

time constant indicating the time for recovery in muscle phosphocreatine levels following exercise as a metric of muscle oxidative capacity.

Outcome measures

Measure	Stroke n=9 Participants those with condition Treadmill walking: Subjects will perform treadmill walking at a self-selected velocity Magnetic resonance spectroscopy: Muscle oxidative capacity will be assessed via Magnetic resonance spectroscopy (31P-MRS)	Control n=6 Participants those without condition Treadmill walking: Subjects will perform treadmill walking at a self-selected velocity Magnetic resonance spectroscopy: Muscle oxidative capacity will be assessed via Magnetic resonance spectroscopy (31P-MRS)
Magnetic Resonance Spectroscopy of Muscle Metabolic Properties	43.22 seconds Standard Deviation 9.8	35.39 seconds Standard Deviation 8.26

Adverse Events

Stroke

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Stroke n=15 participants at risk those with condition Treadmill walking: Subjects will perform treadmill walking at a self-selected velocity Magnetic resonance spectroscopy: Muscle oxidative capacity will be assessed via Magnetic resonance spectroscopy (31P-MRS)	Control n=15 participants at risk those without condition Treadmill walking: Subjects will perform treadmill walking at a self-selected velocity Magnetic resonance spectroscopy: Muscle oxidative capacity will be assessed via Magnetic resonance spectroscopy (31P-MRS)
Musculoskeletal and connective tissue disorders fall at home	6.7% 1/15 • Number of events 1	0.00% 0/15

Additional Information

Chris Gregory

Ralph H Johnson VAMC

Phone: (843)792-1078

Email: Christopher.Gregory@va.gov

Results disclosure agreements

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