Trial Outcomes & Findings for Hybrid-FES Exercise to Prevent Cardiovascular Declines in Acute SCI (NCT NCT02139436)

NCT ID: NCT02139436

Last Updated: 2022-03-22

Results Overview

Volunteers will perform an incremental exercise test of FES- or arms-only rowing to determine maximal oxygen uptake.

Recruitment status

COMPLETED

Study phase

Target enrollment

68 participants

Primary outcome timeframe

Baseline and 6 months

Results posted on

2022-03-22

Participant Flow

Participant milestones

Participant milestones
Measure	FES-row-training Subjects will perform 6 months of FES-row-training. FES-row-training	Wait-list Time Control Subjects perform 6 months of their standard of care Time Control	Arms-only-row-training Subjects will perform 6 months of arms-only row training Arms-only-row training
Overall Study STARTED	41	14	13
Overall Study COMPLETED	41	14	13
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Hybrid-FES Exercise to Prevent Cardiovascular Declines in Acute SCI

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Total n=68 Participants Total of all reporting groups	FES-row-training n=41 Participants Subjects will perform 6 months of FES-row-training. FES-row-training	Wait-list Time Control n=14 Participants Subjects perform 6 months of their standard of care Time Control	Arms-only-row-training n=13 Participants Subjects will perform 6 months of arms-only row training Arms-only-row training
Age, Categorical <=18 years	0 Participants n=4 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	68 Participants n=4 Participants	41 Participants n=5 Participants	14 Participants n=7 Participants	13 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=4 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	28 years STANDARD_DEVIATION 6 • n=4 Participants	28 years STANDARD_DEVIATION 5 • n=5 Participants	28 years STANDARD_DEVIATION 6 • n=7 Participants	28 years STANDARD_DEVIATION 6 • n=5 Participants
Sex: Female, Male Female	10 Participants n=4 Participants	8 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	58 Participants n=4 Participants	33 Participants n=5 Participants	13 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=4 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=4 Participants	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=4 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=4 Participants	3 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	47 Participants n=4 Participants	28 Participants n=5 Participants	11 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	4 Participants n=4 Participants	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=4 Participants	6 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	68 Participants n=4 Participants	41 Participants n=5 Participants	14 Participants n=7 Participants	13 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 6 months

Population: The reported results represent a sub-population of the total number of subjects who completed the study. Some subjects did not complete the 6 month VO2 or their results were removed due to quality control or not meeting the criteria for a good test. Therefore, the presented numbers represent reliable and unbiased data.

Volunteers will perform an incremental exercise test of FES- or arms-only rowing to determine maximal oxygen uptake.

Outcome measures

Outcome measures
Measure	Waitlist Controls n=11 Participants Controls (no structured exercise)	Arms Only n=11 Participants Arms Only Rowing	FES-Rowing n=16 Participants Functional Electrical Stimulation Rowing
Change From Baseline in Exercise Capacity at 6 Months Baseline	14.6 ml/kg/min Standard Error 3.4	18.5 ml/kg/min Standard Error 3.7	17.1 ml/kg/min Standard Error 1.2
Change From Baseline in Exercise Capacity at 6 Months 6 Months	13.9 ml/kg/min Standard Error 2.5	18.2 ml/kg/min Standard Error 4.4	18.9 ml/kg/min Standard Error 1.5

PRIMARY outcome

Timeframe: Baseline, 6 months

Population: These are subgroups of the main study population. Exercise groups were combined.

We will use a 5th generation General Electric Healthcare dual x-ray absorptiometry(DXA) scanner for regional fat measurements, the DXA software can be used to define standard regions that will allow comparability of measurements throughout the study.

Outcome measures

Outcome measures
Measure	Waitlist Controls n=6 Participants Controls (no structured exercise)	Arms Only n=18 Participants Arms Only Rowing	FES-Rowing n=7 Participants Functional Electrical Stimulation Rowing
Change From Baseline in Visceral Adiposity at 6 Months 6-Months	16057 g Standard Error 1952	11247 g Standard Error 1390	12197 g Standard Error 2492
Change From Baseline in Visceral Adiposity at 6 Months Baseline	13649 g Standard Error 1320	10503 g Standard Error 1235	10945 g Standard Error 2310

PRIMARY outcome

Timeframe: Baseline and 6 months

Population: The reported results represent a sub-population of the total number of subjects who completed the study. Some subjects did not complete the 6 month echocardiography or their results were removed due to quality control or not meeting the criteria for a good test. Therefore, the presented numbers represent reliable and unbiased data.

Echocardiography was performed using a commercially available system(Vivid-1, General Electric Healthcare)to obtain measures of left ventricular wall thickness and left ventricular diastolic function.

Outcome measures

Outcome measures
Measure	Waitlist Controls n=7 Participants Controls (no structured exercise)	Arms Only n=6 Participants Arms Only Rowing	FES-Rowing n=17 Participants Functional Electrical Stimulation Rowing
Change From Baseline in Myocardial Structure at 6 Months. Baseline	136 g Standard Error 4	149 g Standard Error 5	143 g Standard Error 2
Change From Baseline in Myocardial Structure at 6 Months. 6 Months	129 g Standard Error 8	133 g Standard Error 4	138 g Standard Error 4

PRIMARY outcome

Timeframe: Baseline and 6 months

Population: The reported results represent a sub-population of the total number of subjects who completed the study. Some subjects did not complete the 6 month blood draw. Therefore, the presented numbers represent reliable and unbiased data.

Blood will be taken via standard venipuncture to measure the homeostasis model assessment of insulin resistance (HOMA-IR). HOMA-IR is a measure of insulin resistance/sensitivity calculated by multiplying fasting insulin (μU/mL) by fasting glucose (mg/dL) and divided by a constant (405). A higher value indicates higher insulin resistance.

Outcome measures

Outcome measures
Measure	Waitlist Controls n=4 Participants Controls (no structured exercise)	Arms Only n=2 Participants Arms Only Rowing	FES-Rowing n=16 Participants Functional Electrical Stimulation Rowing
Change From Baseline in Insulin Sensitivity at 6 Months. Baseline	2.7 HOMA-IR Index Standard Error 1.7	0.9 HOMA-IR Index Standard Error 0.1	1.4 HOMA-IR Index Standard Error 0.5
Change From Baseline in Insulin Sensitivity at 6 Months. 6 Months	3.1 HOMA-IR Index Standard Error 1.5	0.6 HOMA-IR Index Standard Error 0.2	1.7 HOMA-IR Index Standard Error 0.6

PRIMARY outcome

Timeframe: Baseline and 6 months

Blood will be taken via standard venipuncture to measure: total cholesterol.

Outcome measures

Outcome measures
Measure	Waitlist Controls n=16 Participants Controls (no structured exercise)	Arms Only n=4 Participants Arms Only Rowing	FES-Rowing n=2 Participants Functional Electrical Stimulation Rowing
Change From Baseline in Blood Lipids at 6 Months Baseline	170 mg/dL Standard Error 8	157 mg/dL Standard Error 9	158 mg/dL Standard Error 4
Change From Baseline in Blood Lipids at 6 Months 6 Months	171 mg/dL Standard Error 8	141 mg/dL Standard Error 10	149 mg/dL Standard Error 4

Adverse Events

FES-row-training

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Wait-list Time Control

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Arms-only-row-training

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	FES-row-training n=41 participants at risk Subjects will perform 6 months of FES-row-training. FES-row-training	Wait-list Time Control n=14 participants at risk Subjects perform 6 months of their standard of care Time Control	Arms-only-row-training n=13 participants at risk Subjects will perform 6 months of arms-only row training Arms-only-row training
Cardiac disorders Autonomic Dysreflexia	0.00% 0/41 • up to 6 months	7.1% 1/14 • Number of events 2 • up to 6 months	7.7% 1/13 • Number of events 2 • up to 6 months

Other adverse events

Other adverse events
Measure	FES-row-training n=41 participants at risk Subjects will perform 6 months of FES-row-training. FES-row-training	Wait-list Time Control n=14 participants at risk Subjects perform 6 months of their standard of care Time Control	Arms-only-row-training n=13 participants at risk Subjects will perform 6 months of arms-only row training Arms-only-row training
Cardiac disorders Low Blood Pressure	2.4% 1/41 • Number of events 1 • up to 6 months	0.00% 0/14 • up to 6 months	0.00% 0/13 • up to 6 months
Skin and subcutaneous tissue disorders Skin Ulcer	2.4% 1/41 • Number of events 1 • up to 6 months	0.00% 0/14 • up to 6 months	7.7% 1/13 • Number of events 1 • up to 6 months
Cardiac disorders Elevated Blood Pressure	2.4% 1/41 • Number of events 1 • up to 6 months	0.00% 0/14 • up to 6 months	0.00% 0/13 • up to 6 months
Musculoskeletal and connective tissue disorders Arthritis	4.9% 2/41 • Number of events 2 • up to 6 months	0.00% 0/14 • up to 6 months	0.00% 0/13 • up to 6 months
Gastrointestinal disorders Nausea	7.3% 3/41 • Number of events 3 • up to 6 months	0.00% 0/14 • up to 6 months	0.00% 0/13 • up to 6 months

Additional Information

Glen Picard

Spaulding Rehabilitation Hospital

Phone: 6177585511

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place