- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT00910507
The Impact of Exercise Counseling on Exercise Behavior in People With Type 2 Diabetes: A Randomized Clinical Trial
The Impact of Physical Therapist-Directed Exercise Counseling Combined With Fitness Center-Based Exercise Training on Stage of Exercise Behavior in People With Type 2 Diabetes: A Randomized Clinical Trial
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
Type 2 diabetes is a chronic, metabolic disease characterized by hyperglycemia resulting from insulin resistance. Research studies indicate that complications such as cardiovascular disease, peripheral vascular disease, retinopathy, and loss of physical function are associated with type 2 diabetes. Clinical management of people with type 2 diabetes consists of medical nutrition therapy, pharmacological therapy, and exercise. Exercise has been shown to improve risk factors associated with complications of type 2 diabetes such as elevated plasma glucose, elevated blood pressure, loss of muscular strength, and loss of exercise capacity. In fact, the American Diabetes Association and American College of Sports Medicine have published position statements recommending the use of exercise, specifically resistance and aerobic training, as an intervention for people with type 2 diabetes. However, 31 percent of people with type 2 diabetes have reported no regular physical activity and an additional 38 percent have reported less than recommended levels of physical activity. Therefore, interventions to promote regular exercise behavior in people with type 2 diabetes are clinically important by potentially preventing type 2 diabetes-related complications.
Previous studies have investigated the impact of exercise counseling on exercise behavior in people with type 2 diabetes. However, these studies have limitations such as lack of agreement with exercise training guidelines for people with type 2 diabetes and research design flaws. This current study investigates the effect of a novel, physical therapist-directed exercise counseling combined with fitness center-based exercise training intervention on stage of exercise behavior in people with type 2 diabetes.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Arkansas
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Conway, Arkansas, Stany Zjednoczone, 72035
- University of Central Arkansas
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Type 2 diabetes
- Consider medically stable to participate by a physician
Exclusion Criteria:
- Contraindication for exercise testing
- Uncontrolled hypertension
- Proliferative retinopathy
- Severe peripheral neuropathy
- Nephropathy
- Autonomic neuropathy
- Unable to participate due to a physical impairment
- Fasting plasma glucose greater than 250 mg/dL
- Involved in resistance or aerobic training on 2 or more days per week
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: Exercise counseling
Each participant in the experimental group receives exercise counseling from the same physical therapist as described in previous research.
In short, during each exercise counseling session, the physical therapist addresses the benefits of exercise for people with type 2 diabetes, advises each participant to adhere to the prescribed exercise program, and assists each participant by reviewing the prescribed exercise program.
Exercise counseling is tailored to the stage of exercise behavior as described in previous literature.
The experimental group is also provided access to a fitness center.
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Each participant in the experimental group receives 2 months of exercise counseling from the same physical therapist as described in previous research.
In short, during each exercise counseling session, the physical therapist addresses the benefits of exercise for people with type 2 diabetes, advises each participant to adhere to the prescribed exercise program, and assists each participant by reviewing the prescribed exercise program.
Exercise counseling is tailored to the stage of exercise behavior as described in previous literature.
The experimental group is also provided access to a fitness center.
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Aktywny komparator: Supervised exercise training
Participants who are randomly allocated to the comparison group receive a 2-month supervised exercise program.
Each participant in the comparison group receives the same prescribed exercise program as the experimental group and is supervised during each exercise training session by a trained co-investigator in a controlled exercise laboratory setting.
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Participants who are randomly allocated to the comparison group receive a 2-month supervised exercise program.
Each participant in the comparison group receives the same prescribed exercise program as the experimental group and is supervised during each exercise training session by a trained co-investigator in a controlled exercise laboratory setting.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Ramy czasowe |
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Stage of Exercise Behavior
Ramy czasowe: 2 months
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2 months
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Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: James D Taylor, PT, PhD, University of Central Arkansas
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- UCA IRB 07-070
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