- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT05184673
Moderate Aerobic Activity Through Yoga (MAT)
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
The 2018 Physical Activity Guidelines for Americans recommend 150 minutes of moderate intensity physical activity each week to promote health. The most recent scientific advisory committee had insufficient evidence to provide recommendations on how the physical practice of yoga fits into the physical activity guidelines. Currently, there have been few studies done on yoga and its relative intensity. Previous randomized, cross-over trial to determine the effects of room temperature (hot yoga versus thermo-neutral environment) on subjective and objective markers of exercise intensity. They concluded that using objective markers (%VO2max) both thermo-neutral and hot yoga would be considered light intensity activity. Previous investigation of power yoga, heart rate, skin temperature, and body mass to determine that power yoga could be considered a moderate-vigorous intensity activity.
Currently, there is a gap in the research on understanding the intensity of exercise offered within a typical yoga studio including "flow", hatha/classical, and hot yoga. Most yoga classes are about 60 minutes in length, and yoga classes of that length have not been investigated. There is also minimal research done on whether wearable activity trackers and accelerometers are able to accurately assess heart rate, and therefore activity intensity level in a yoga setting.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
-
-
Virginia
-
Blacksburg, Virginia, Stany Zjednoczone, 24060
- Samantha M Harden
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Assessed as physical activity readiness i. For those 65-70 years of age. We will also use the Physical Readiness Questionnaire Plus-this "plus" version was developed to be more inclusive of those with limited mobility and not to over-exclude older adults in other clinical trials. If a participant fails the Physical Activity Readiness Questionnaire + (PARQ+), a physician's approval will be mandatory ii. For those 70-85 years of age. Complete PARQ+ as well as physician approval.
- Comprehension of English language
- Able to physically attend class at the yoga studio
Exclusion Criteria:
- Contraindication to physical activity including but not limited to people who can independently walk and stand. This will be part of the verbal screening protocol using Falls Efficacy Scale (FES). This scale has a minimum of 16 (no concern about falling) to maximum of 64 (severe concern about falling). Participants with FES score > 23 will be deemed high concern about falling and be excluded from participation.
- Assesses the presence and severity of 13 psychiatric symptom domains that cut across diagnostic boundaries. These domains include depression, anger, mania, anxiety, somatic symptoms, sleep disturbance, psychosis, obsessive thoughts and behaviors, suicidal thoughts and behaviors, substance use (e.g., alcohol, nicotine, prescription medication, and illicit substance use), personality functioning, dissociation, and cognition/memory problems in adults. Level 1 of this measure includes 23 questions across the 13 domains.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Badania usług zdrowotnych
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Aktywny komparator: hatha thermo-neutral
The hatha classes will hold each pose for 5 breaths in a room temperature (~70 degrees Fahrenheit) space.
Yoga sessions will be led by a 500hr Registered Yoga Teacher.
This reduces the risk for injury due to the extensive training the yoga teacher will have received and the knowledge of cuing and sequencing for best practice.
All study personnel will be vaccinated against SARS-CoV-2, reducing the risk of spreading SARS-CoV-2.
|
These are all active comparator yoga sequences
|
|
Aktywny komparator: hatha hot
The hatha hot classes will hold each pose for 5 breaths in a room heated to 95 degrees Fahrenheit.
Yoga sessions will be led by a 500hr Registered Yoga Teacher.
This reduces the risk for injury due to the extensive training the yoga teacher will have received and the knowledge of cuing and sequencing for best practice.
All study personnel will be vaccinated against SARS-CoV-2, reducing the risk of spreading SARS-CoV-2.
|
These are all active comparator yoga sequences
|
|
Aktywny komparator: flow thermo-neutral
The flow hot classes will flow from each pose (one breath per movement) a room temperature (~70 degrees Fahrenheit) space.
Yoga sessions will be led by a 500hr Registered Yoga Teacher.
This reduces the risk for injury due to the extensive training the yoga teacher will have received and the knowledge of cuing and sequencing for best practice.
All study personnel will be vaccinated against SARS-CoV-2, reducing the risk of spreading SARS-CoV-2.
|
These are all active comparator yoga sequences
|
|
Aktywny komparator: flow hot
The flow hot classes will flow from each pose (one breath per movement) in a room heated to 95 degrees Fahrenheit.
Yoga sessions will be led by a 500hr Registered Yoga Teacher.
This reduces the risk for injury due to the extensive training the yoga teacher will have received and the knowledge of cuing and sequencing for best practice.
All study personnel will be vaccinated against SARS-CoV-2, reducing the risk of spreading SARS-CoV-2.
|
These are all active comparator yoga sequences
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Continuous heart rate
Ramy czasowe: orientation to week 0 (baseline)
|
Polar Version OH1
|
orientation to week 0 (baseline)
|
|
Continuous heart rate
Ramy czasowe: orientation to week 1
|
Polar Version OH1
|
orientation to week 1
|
|
Continuous heart rate
Ramy czasowe: orientation to week 1.5
|
Polar Version OH1
|
orientation to week 1.5
|
|
Continuous heart rate
Ramy czasowe: orientation to week 2
|
Polar Version OH1
|
orientation to week 2
|
|
Continuous heart rate
Ramy czasowe: orientation to week 2.5
|
Polar Version OH1
|
orientation to week 2.5
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Modified Borg Scale
Ramy czasowe: orientation to week 1
|
2-items, 1 (very light activity) -10 (maximal effort)
|
orientation to week 1
|
|
Modified Borg Scale
Ramy czasowe: orientation to week 1.5
|
2-items, 1 (very light activity) -10 (maximal effort)
|
orientation to week 1.5
|
|
Modified Borg Scale
Ramy czasowe: orientation to week 2
|
2-items, 1 (very light activity) -10 (maximal effort)
|
orientation to week 2
|
|
Modified Borg Scale
Ramy czasowe: orientation to week 2.5
|
2-items, 1 (very light activity) -10 (maximal effort)
|
orientation to week 2.5
|
|
Yoga Self Efficacy Scale
Ramy czasowe: Baseline
|
12-item, 9 point Likert scale, higher score, more self-efficacious
|
Baseline
|
|
Stanford Leisure-Time Activity Categorical Item
Ramy czasowe: Baseline
|
Score of 1-6, higher is better outcome
|
Baseline
|
Współpracownicy i badacze
Śledczy
- Główny śledczy: Samantha M Harden, PhD, Virginia Polytechnic Institute and State University
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .