- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04389736
Effects of NMES on Energy Expenditure, Glycaemia and Hormonal Responses to Glucose Ingestion
11 maj 2020 uppdaterad av: Yung-Chih Chen, National Taiwan Normal University
Effects of Self-selected Maiximal Intensity of Neuromuscular Electrical Stimulation (NMES) on Energy Expenditure, Glycaemia and Hormonal Responses on Healthy Individuals
The purpose of this study is to investigate whether self-selected neuromuscular stimulation (NMES) affects energy expenditure, glycaemia and hormonal responses in healthy men and women
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
Participants were asked to perform 3 trials [sitting (SIT), standing (STAND) and sitting with neuromuscular electrical stimulation (NMES) to the lower limbs in randomised counter-balanced study design.
Trials were separated by at least 48 h and were completed within 14 days.
In all trials, participants were required to remain relaxed and motionless.
SIT: participants sat in a chair with back, arms and legs supported.
STAND: participants were asked to stand with arms supported and feet spaced approximately 15 cm apart.
If needed, adjustment of standing posture was allowed during the standing trial to prevent orthostatic hypotension.
NMES: prior to the NMES trial, participants underwent preliminary testing to ensure that stimulation was comfortable.
Before the NMES, a small area of the body hair was shaved and skin was cleaned with an alcohol wipe and electrodes were stuck to the surface of the skin.
Small electrodes placed (5*5 cm) on the lower limb of both legs (gastrocnemius, rectus femoris, vastus medialis).
The two devices (EM 80, Beurer UK Ltd, Golborne, UK) were set up with the frequency of 20 Hz along with stimulation period of 1 second on and 1 second off throughout a 2 h oral glucose tolerance test (OGTT).
The instruction for NMES intensity was that the maximal intensity participants were be able to withstand for 2 hours whilst imagining sitting at home watching TV without feeling discomfort.
Prior to the OGTT, 5 min was given to identify the suitable intensity of stimulation and within the first 10 min of the OGTT participants were allowed to adjust the intensity once, after which, the intensity remained the same for the rest of OGTT.
Participants were asked to sit in a chair with back, arms and legs supported during the stimulation.
During trials, participants could watch TV, or read, but typing on a laptop or computer were avoided.
Studietyp
Interventionell
Inskrivning (Faktisk)
9
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
-
Taipei, Taiwan
- National Taiwan Normal University
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 65 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Healthy men and women
- Aged between 18 to 65 years
- Weight stable for more than 3 months (no change in weight +/- 3%)
- Non-smoker
Exclusion Criteria:
- Personal history of/existing diabetes, cardiovascular disease, metabolic disease or dyslipidaemia
- Taking medications that may influence lipid or carbohydrate metabolism or immune system function
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: SIT
Sitting
|
Participants sat in a chair with back, arms and legs supported.
|
|
Experimentell: STAND
Standing
|
Participants were asked to stand with arms supported and feet spaced approximately 15 cm apart.
If needed, adjustment of standing posture was allowed during standing trial to prevent orthostatic hypotension.
|
|
Experimentell: NMES
Self-selected maximal intensity of neuromuscular electrical stimulation
|
Small electrodes placed (5*5 cm) on the lower limb of both legs.
The instruction for NMES intensity was that the maximal intensity participants were be able to withstand for 2 hours whilst imagining sitting at home watching TV without feeling discomfort.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Changes in total energy expenditure during OGTT test.
Tidsram: 120 minutes
|
Changes in total energy expenditure during OGTT test.
|
120 minutes
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Changes in blood glycaemic responses during OGTT test.
Tidsram: 120 minutes
|
Changes in blood glycaemic responses during OGTT test.
|
120 minutes
|
|
Changes in blood insulinaemic responses during OGTT test.
Tidsram: 120 minutes
|
Changes in blood insulinaemic responses during OGTT test.
|
120 minutes
|
|
Changes in blood pressure during OGTT test.
Tidsram: 120 minutes
|
Changes in blood pressure during OGTT test.
|
120 minutes
|
|
Changes in heart rate during OGTT test.
Tidsram: 120 minutes
|
Changes in heart rate during OGTT test.
|
120 minutes
|
|
Changes in gut hormones (GLP-1, GIP & PYY etc.) responses during OGTT test.
Tidsram: 120 minutes
|
Changes in gut hormones (GLP-1, GIP & PYY etc.) responses during OGTT test.
|
120 minutes
|
|
Changes in total carbohydrate during OGTT test.
Tidsram: 120 minutes
|
Changes in total carbohydrate during OGTT test.
|
120 minutes
|
|
Changes in total lipid oxidation during OGTT test.
Tidsram: 120 minutes
|
Changes in total lipid oxidation during OGTT test.
|
120 minutes
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
27 november 2018
Primärt slutförande (Faktisk)
9 januari 2019
Avslutad studie (Faktisk)
20 januari 2019
Studieregistreringsdatum
Först inskickad
27 mars 2020
Först inskickad som uppfyllde QC-kriterierna
11 maj 2020
Första postat (Faktisk)
15 maj 2020
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
15 maj 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
11 maj 2020
Senast verifierad
1 maj 2020
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- EP 17/18 230
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .