Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06188481
Status:
RECRUITING
Last Update Posted:
2024-06-07
First Post:
2023-12-07
Brief Title:
Efficacy of Whole-body Electromyostimulation WB-EMS Training in Participants With Pre-diabetes
Sponsor:
University Hospital Tuebingen
Organization:
University Hospital Tuebingen
Study Overview
Official Title:
Efficacy of Whole-body Electromyostimulation WB-EMS Training on Glycemic Control in People With Prediabetes a Randomized Controlled Pilot-study
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this pilot study is to assess the efficacy of the intervention WB-EMS Training in a sedentary group of adults with pre-diabetes and to estimate the potential effect sizes
The main goals and questions it aims to answer are
Efficacy WB-EMS training in sedentary adults with pre-diabetes
Has WB-EMS training positive effects on HbA1c and other biomarkers
Researchers will compare the intervention group with two control groups to see if WB-EMS training has effects on pre-diabetes
The main goals and questions it aims to answer are
Efficacy WB-EMS training in sedentary adults with pre-diabetes
Has WB-EMS training positive effects on HbA1c and other biomarkers
Researchers will compare the intervention group with two control groups to see if WB-EMS training has effects on pre-diabetes
Detailed Description:
The study is planned as a randomized controlled pilot study The intervention phase duration is set to 16 weeks Prior to the study start all subjects will be screened for their eligibility according to defined inclusion and exclusion criteria
Sixty eligible sedentary individuals with pre-diabetes between the ages of 40 and 65 years will be randomised to one intervention group n20 and two control groups n20 each
The main exercise intervention will be conducted via WB-EMS using a medical device approved system miha bodytec Type II Gersthofen Germany Participants in the intervention and one control group will receive an activity tracker vivosmart 5 Garmin to measure daily steps during the 16-week intervention phase All study groups will further receive an evidence-based lifestyle education programme 6 x 20 minutes for 3 months which provides education information and advice to prevent disease progression and improve quality of life and mobility
During the baseline visit and after 16 weeks endpoint measurements incl blood biomarkers cardiometabolic and body composition parameters will be assessed The intervention group will additionally attend a follow-up visit after 32 weeks and the parameters will be assessed again
Sixty eligible sedentary individuals with pre-diabetes between the ages of 40 and 65 years will be randomised to one intervention group n20 and two control groups n20 each
The main exercise intervention will be conducted via WB-EMS using a medical device approved system miha bodytec Type II Gersthofen Germany Participants in the intervention and one control group will receive an activity tracker vivosmart 5 Garmin to measure daily steps during the 16-week intervention phase All study groups will further receive an evidence-based lifestyle education programme 6 x 20 minutes for 3 months which provides education information and advice to prevent disease progression and improve quality of life and mobility
During the baseline visit and after 16 weeks endpoint measurements incl blood biomarkers cardiometabolic and body composition parameters will be assessed The intervention group will additionally attend a follow-up visit after 32 weeks and the parameters will be assessed again
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None