- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03545802
Home-HIT and Type 1 Diabetes
A Multi-Disciplinary Evaluation of Home-Based High-Intensity Interval Training in People With Type 1 Diabetes: A Pilot Study
Studieöversikt
Detaljerad beskrivning
This study aimed to use a multi-disciplinary approach to evaluate a home-based high-intensity interval training (Home-HIT) intervention in people with type 1 diabetes.
Eleven individuals with type 1 diabetes (4 men/7 women; age 30±3 years; BMI 27.1±1.2 kg·m-2; V ̇O2peak 32.4±2.1 ml∙kg∙min-1; duration of type 1 diabetes 10±2 years) completed six weeks of Home-HIT. The effect of Home-HIT on V ̇O2peak, blood pressure, insulin dose and glycaemic profile was assessed pre and post-training. Adherence and ability to meet target heart rate (HR) thresholds (compliance) were monitored using a HR monitor and mobile phone application. Change in glycaemia was measured pre, post and 1h post exercise sessions throughout the six-week period. A qualitative online survey was completed post-training.
This is the first study to combine physiological outcomes with a qualitative evaluation of a training intervention in people with type 1 diabetes. Home-HIT resulted in high adherence alongside increased V ̇O2peak and decreased insulin dose. Because Home-HIT is time-efficient and removes barriers to exercise including fear of hypoglycaemia, it may represent an effective strategy to increase exercise participation in people with type 1 diabetes.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Merseyside
-
Liverpool, Merseyside, Storbritannien, L3 3AF
- Liverpool John Moores University
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- duration of type 1 diabetes >6 months,
- no significant history of hyper- or hypoglycaemia
Exclusion Criteria:
- duration of type 1 diabetes <6 months,
- significant history of hyper- or hypoglycaemia,
- pregnancy or planning pregnancy,
- uncontrolled hypertension (>180/100 mmHg),
- angina
- autonomic neuropathy,
- taking any medication that affects heart rate (HR)
- major surgery planned within 6 weeks of the study
- severe nonproliferative
- unstable proliferative retinopathy
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Training
6 weeks of home-based high intensity interval training
|
Participants completed 6 weeks of home-based high-intensity interval training 3 times per week
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
change in maximal aerobic capacity
Tidsram: change in baseline maximal aerobic capacity at 6 weeks
|
Maximal aerobic capacity was measured pre and post 6 week training intervention using a MOXUS gas analyser on a stationary cycle ergometer
|
change in baseline maximal aerobic capacity at 6 weeks
|
|
adherence over the course of the training programme
Tidsram: adherence to the training programme over the course of the 6 week intervention
|
session completion rate (adherence) was assessed
|
adherence to the training programme over the course of the 6 week intervention
|
|
Compliance over the course of the training programme
Tidsram: compliance to the training programme over the course of the 6 week intervention
|
ability to meet target heart rates (compliance) was assessed
|
compliance to the training programme over the course of the 6 week intervention
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
change in insulin sensitivity
Tidsram: change in baseline insulin sensitivity at 6 weeks
|
insulin dose was recorded pre and post training by participants
|
change in baseline insulin sensitivity at 6 weeks
|
|
change in glycaemic control
Tidsram: change in baseline glycaemic control at 6 weeks
|
participants recorded their blood glucose concentrations in the first and final weeks of the intervention
|
change in baseline glycaemic control at 6 weeks
|
Samarbetspartners och utredare
Sponsor
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Home-HIT_T1D
Plan för individuella deltagardata (IPD)
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IPD-planbeskrivning
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