- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Merseyside
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Liverpool, Merseyside, Det Forenede Kongerige, L3 3AF
- Liverpool John Moores University
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Training
6 weeks of home-based high intensity interval training
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Participants completed 6 weeks of home-based high-intensity interval training 3 times per week
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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change in maximal aerobic capacity
Tidsramme: change in baseline maximal aerobic capacity at 6 weeks
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Maximal aerobic capacity was measured pre and post 6 week training intervention using a MOXUS gas analyser on a stationary cycle ergometer
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change in baseline maximal aerobic capacity at 6 weeks
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adherence over the course of the training programme
Tidsramme: adherence to the training programme over the course of the 6 week intervention
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session completion rate (adherence) was assessed
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adherence to the training programme over the course of the 6 week intervention
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Compliance over the course of the training programme
Tidsramme: compliance to the training programme over the course of the 6 week intervention
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ability to meet target heart rates (compliance) was assessed
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compliance to the training programme over the course of the 6 week intervention
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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change in insulin sensitivity
Tidsramme: change in baseline insulin sensitivity at 6 weeks
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insulin dose was recorded pre and post training by participants
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change in baseline insulin sensitivity at 6 weeks
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change in glycaemic control
Tidsramme: change in baseline glycaemic control at 6 weeks
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participants recorded their blood glucose concentrations in the first and final weeks of the intervention
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change in baseline glycaemic control at 6 weeks
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Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Home-HIT_T1D
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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