FES Cycling and Nutritional Counseling for Battling Obesity After SCI
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|ClinicalTrials.gov Identifier: NCT03810963|
Recruitment Status : Completed
First Posted : January 21, 2019
Last Update Posted : October 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injuries||Combination Product: HIIT-FES Cycling combined with Nutritional Counseling Other: Nutritional Counseling Only||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||The hypothesis for our research aim is that combining RG-HIIT-FES cycling with nutritional counseling will be more effective than nutritional counseling alone for reducing obesity and enhancing cardiometabolic health markers in persons with chronic SCI. This will be tested using a subject-matched controlled pre-post design. The experimental group receives 30 minutes of RG-HIIT-FES cycling three times per week for eight weeks and nutritional counseling over the telephone for 30 minutes one time per week for eight weeks. The control group receives the nutritional counseling only.|
|Masking:||None (Open Label)|
|Official Title:||Electrically Induced Cycling and Nutritional Counseling for Counteracting Obesity After SCI|
|Actual Study Start Date :||May 1, 2017|
|Actual Primary Completion Date :||May 1, 2019|
|Actual Study Completion Date :||May 1, 2019|
Experimental: FES Cycling and Nutrition Counseling
HIIT-FES cycling will be performed 30 minutes per session, 3 times per week for 3 weeks combined with
Nutrition counseling will be completed via telephone for 30 minutes once per week for 8 weeks.
Combination Product: HIIT-FES Cycling combined with Nutritional Counseling
High intensity interval training functional electrical stimulation cycling for 30 minutes, three days per week for eight weeks, Nutritional counseling over the telephone for 30 minutes once per week for eight weeks.
Nutritional Counseling Only
Nutritional counseling will be completed via telephone for 30 minutes once per week for 8 weeks.
Other: Nutritional Counseling Only
Nutritional counseling over the telephone for 30 minutes once per week for eight weeks.
- Body Fat Percentage [ Time Frame: Eight Weeks ]Percentage of body fat measured during pre- and post-testing
- Fat mass and lean mass [ Time Frame: Eight Weeks ]Total fat and lean mass in kg measured during pre- and post-testing
- Arterial health via flow mediated dilation [ Time Frame: Eight Weeks ]Measurement of arterial diameter change in mm after blood flow restriction during pre- poste testing
- Blood glucose testing [ Time Frame: 8 weeks ]Using finger stick blood droplet method pre- and post-testing for blood glucose and HbA1c measures
- Pre- post- intervention three day dietary recall [ Time Frame: Eight Weeks ]Prior to and after the intervention a 3 day dietary recall will be completed to determine changes in dietary habits.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03810963
|United States, Mississippi|
|William Carey University Physical Therapy Program|
|Hattiesburg, Mississippi, United States, 39401|
|Principal Investigator:||David Dolbow, DPT, PhD||William Carey University|