Trial Outcomes & Findings for Adjuvant Benefit of NMES to Supervised Exercise in Patients With IC (NCT NCT02429310)

Results Overview

For the initial claudication distance measurement, a fixed load treadmill test will be carried out at 3.5 km/h with a 10% gradient. The initial claudication distance (ICD) is the distance walked until the onset of pain.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

42 participants

Primary outcome timeframe

Change in baseline treadmill walking distance at 6 weeks (positive numbers indicate increase from baseline, negative numbers indicate decrease from baseline) - 6 week - baseline values.

Results posted on

2020-10-08

Participant Flow

Participant milestones

Participant milestones
Measure	Supervised Exercise Only This is the cohort of patients with Intermittent Claudication that will receive standard care of a supervised exercise programme only.	NMES + Supervised Exercise This cohort of patients with Intermittent Claudication will receive the standard care of supervised exercise plus the use of a Revitive IX neuromuscular electrical stimulation device (Intervention) as per the protocol. The adjunctive benefit of the latter intervention compared to standard treatment alone will then be assessed. Revitive IX: This is a neuromuscular electrical stimulation device
Overall Study STARTED	22	20
Overall Study COMPLETED	20	17
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Supervised Exercise Only This is the cohort of patients with Intermittent Claudication that will receive standard care of a supervised exercise programme only.	NMES + Supervised Exercise This cohort of patients with Intermittent Claudication will receive the standard care of supervised exercise plus the use of a Revitive IX neuromuscular electrical stimulation device (Intervention) as per the protocol. The adjunctive benefit of the latter intervention compared to standard treatment alone will then be assessed. Revitive IX: This is a neuromuscular electrical stimulation device
Overall Study Lost to Follow-up	1	2
Overall Study Protocol Violation	1	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Supervised Exercise Only n=22 Participants This is the cohort of patients with Intermittent Claudication that will receive standard care of a supervised exercise programme only.	NMES + Supervised Exercise n=20 Participants This cohort of patients with Intermittent Claudication will receive the standard care of supervised exercise plus the use of a Revitive IX neuromuscular electrical stimulation device (Intervention) as per the protocol. The adjunctive benefit of the latter intervention compared to standard treatment alone will then be assessed. Revitive IX: This is a neuromuscular electrical stimulation device	Total n=42 Participants Total of all reporting groups
Age, Continuous	68 years STANDARD_DEVIATION 11 • n=22 Participants	66 years STANDARD_DEVIATION 8 • n=20 Participants	67 years STANDARD_DEVIATION 9 • n=42 Participants
Sex: Female, Male Female	6 Participants n=22 Participants	5 Participants n=20 Participants	11 Participants n=42 Participants
Sex: Female, Male Male	16 Participants n=22 Participants	15 Participants n=20 Participants	31 Participants n=42 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	22 participants n=22 Participants	20 participants n=20 Participants	40 participants n=42 Participants

PRIMARY outcome

Timeframe: Change in baseline treadmill walking distance at 6 weeks (positive numbers indicate increase from baseline, negative numbers indicate decrease from baseline) - 6 week - baseline values.

For the initial claudication distance measurement, a fixed load treadmill test will be carried out at 3.5 km/h with a 10% gradient. The initial claudication distance (ICD) is the distance walked until the onset of pain.

Outcome measures

Outcome measures
Measure	Supervised Exercise Only n=20 Participants This is the cohort of patients with Intermittent Claudication that will receive standard care of a supervised exercise programme only.	NMES + Supervised Exercise n=17 Participants This cohort of patients with Intermittent Claudication will receive the standard care of supervised exercise plus the use of a Revitive IX neuromuscular electrical stimulation device (Intervention) as per the protocol. The adjunctive benefit of the latter intervention compared to standard treatment alone will then be assessed. Revitive IX: This is a neuromuscular electrical stimulation device
Initial Walking Distance Measured by Treadmill	65.60 metres Interval 33.98 to 93.88	95.50 metres Interval 81.4 to 155.3

PRIMARY outcome

Timeframe: Change in baseline treadmill walking distance at 6 weeks (positive numbers indicate increase from baseline, negative numbers indicate decrease from baseline)

For the absolute claudication distance measurement, a fixed load treadmill test will be carried out at 3.5 km/h with a 10% gradient. The absolute claudication distance (ACD) is the distance walked before the participant is forced to stop due to typical pain.

Outcome measures

Outcome measures
Measure	Supervised Exercise Only n=20 Participants This is the cohort of patients with Intermittent Claudication that will receive standard care of a supervised exercise programme only.	NMES + Supervised Exercise n=17 Participants This cohort of patients with Intermittent Claudication will receive the standard care of supervised exercise plus the use of a Revitive IX neuromuscular electrical stimulation device (Intervention) as per the protocol. The adjunctive benefit of the latter intervention compared to standard treatment alone will then be assessed. Revitive IX: This is a neuromuscular electrical stimulation device
Absolute Walking Distance Measured by Treadmill	146.7 metres Interval 70.53 to 214.3	167.4 metres Interval 102.7 to 229.2

SECONDARY outcome

Timeframe: Change in baseline femoral haemodynamics at 6 weeks - 6 weeks - baseline.

Ultrasound assessment of blood flow dynamics in the femoral artery will be obtained at rest, and if randomised to the intervention group, whilst using the device.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Change in baseline flowmetry at 6 weeks

Optical laser flowmetry probes will be used to assess the superficial skin circulation and temperature.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Change in baseline questionnaire scores at 6 weeks

Validated questionnaires including the Edinburgh Claudication Questionnaire and Intermittent Claudication Questionnaire will be obtained at baseline and week 6.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Change in baseline quality of life at 6 weeks

Validated questionnaires including the Euro-Quol 5D and Short Form 36 will be measured at baseline and 6 weeks.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Change of profile at baseline and at 6 weeks

A urine sample will be collected at baseline and at 6 weeks. Mass spectroscopy and nuclear magnetic resonance spectroscopy analysis will be carried out.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Change of profile at baseline and 6 weeks

A serum sample will be collected at baseline and at 6 weeks. Mass spectroscopy and nuclear magnetic resonance spectroscopy analysis will be carried out.

Outcome measures

Outcome data not reported

Adverse Events

Supervised Exercise Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

NMES + Supervised Exercise

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

Professor Alun Davies

Imperial College London

Phone: 02033117320

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place