Trial Outcomes & Findings for Electrical Stimulation of the Muscle Pumps of the Leg (NCT NCT02532556)

Results Overview

Measurement by ultrasound, in right femoral vein. Flow rate (ml/min).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

12 participants

Primary outcome timeframe

Baseline compared to that after 10-mins stimulation (2-mins to take measurements)

Results posted on

2020-11-27

Participant Flow

Participant milestones

Participant milestones
Measure	Electrical Muscle Stimulation Participants All participants for electrical stimulation of respective muscles (tibialis anterior, peroneus longus, gastrocnemius, vastus lateralis, rectus femoris, vastus medialis)
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Electrical Stimulation of the Muscle Pumps of the Leg

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Electrical Muscle Stimulation Participants n=12 Participants All participants for electrical stimulation of respective muscles (tibialis anterior, peroneus longus, gastrocnemius, vastus lateralis, rectus femoris, vastus medialis)
Age, Continuous	23.1 years STANDARD_DEVIATION 3 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United Kingdom	12 participants n=5 Participants
Body mass index	23.1 kg/m^2 STANDARD_DEVIATION 3 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline compared to that after 10-mins stimulation (2-mins to take measurements)

Population: Muscle stimulated

Measurement by ultrasound, in right femoral vein. Flow rate (ml/min).

Outcome measures

Outcome measures
Measure	Vastus Lateralis n=12 Participants	Rectus Femoris n=12 Participants	Vastus Medialis n=12 Participants	Gastrocnemius (Medial) n=12 Participants	Gastrocnemius (Lateral) n=12 Participants	Tibialis Anterior n=12 Participants	Peroneus Longus n=12 Participants
Venous Haemodynamic Measurements (Volume Flow Rate) Baseline	119 ml/min Standard Deviation 67	158 ml/min Standard Deviation 123	158 ml/min Standard Deviation 134	144 ml/min Standard Deviation 100	161 ml/min Standard Deviation 168	164 ml/min Standard Deviation 66	139 ml/min Standard Deviation 135
Venous Haemodynamic Measurements (Volume Flow Rate) Stimulation	148 ml/min Standard Deviation 97	158 ml/min Standard Deviation 123	150 ml/min Standard Deviation 125	178 ml/min Standard Deviation 120	114 ml/min Standard Deviation 205	153 ml/min Standard Deviation 171	149 ml/min Standard Deviation 113

PRIMARY outcome

Timeframe: Baseline compared to that after 10-mins stimulation (2-mins to take measurements)

Population: Muscle stimulated

Measurement by ultrasound, in right femoral vein. Time averaged maximum velocity (cm/s).

Outcome measures

Outcome measures
Measure	Vastus Lateralis n=12 Participants	Rectus Femoris n=12 Participants	Vastus Medialis n=12 Participants	Gastrocnemius (Medial) n=12 Participants	Gastrocnemius (Lateral) n=12 Participants	Tibialis Anterior n=12 Participants	Peroneus Longus n=12 Participants
Venous Haemodynamic Measurements (Time Averaged Maximum Velocity) Stimulation	8.2 cm/s Standard Deviation 15	10.6 cm/s Standard Deviation 10	10.9 cm/s Standard Deviation 8	11.6 cm/s Standard Deviation 19	10.5 cm/s Standard Deviation 11	12 cm/s Standard Deviation 9	10.8 cm/s Standard Deviation 17
Venous Haemodynamic Measurements (Time Averaged Maximum Velocity) Baseline	8.2 cm/s Standard Deviation 10	8.8 cm/s Standard Deviation 14	11.3 cm/s Standard Deviation 10	8.5 cm/s Standard Deviation 12	7.5 cm/s Standard Deviation 12	11.3 cm/s Standard Deviation 13	13.4 cm/s Standard Deviation 14

SECONDARY outcome

Timeframe: During stimulation (10-mins each muscle)

Population: Muscle stimulated

Visual analogue scale (0-minimum pain, to 100-maximum pain)

Outcome measures

Outcome measures
Measure	Vastus Lateralis n=12 Participants	Rectus Femoris n=12 Participants	Vastus Medialis n=12 Participants	Gastrocnemius (Medial) n=12 Participants	Gastrocnemius (Lateral) n=12 Participants	Tibialis Anterior n=12 Participants	Peroneus Longus n=12 Participants
Pain Grading on Stimulation	15 scores on a scale Standard Deviation 1	66.3 scores on a scale Standard Deviation 1	21.3 scores on a scale Standard Deviation 1	28.8 scores on a scale Standard Deviation 1	31.3 scores on a scale Standard Deviation 1	21.3 scores on a scale Standard Deviation 1	30 scores on a scale Standard Deviation 1

Adverse Events

Electrical Muscle Stimulation Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Miss Kate Williams

Imperial College London

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place