- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT05184673
Moderate Aerobic Activity Through Yoga (MAT)
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Virginia
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Blacksburg, Virginia, Stati Uniti, 24060
- Samantha M Harden
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: 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
|
|
Comparatore attivo: 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
|
|
Comparatore attivo: 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
|
|
Comparatore attivo: 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
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Continuous heart rate
Lasso di tempo: orientation to week 0 (baseline)
|
Polar Version OH1
|
orientation to week 0 (baseline)
|
|
Continuous heart rate
Lasso di tempo: orientation to week 1
|
Polar Version OH1
|
orientation to week 1
|
|
Continuous heart rate
Lasso di tempo: orientation to week 1.5
|
Polar Version OH1
|
orientation to week 1.5
|
|
Continuous heart rate
Lasso di tempo: orientation to week 2
|
Polar Version OH1
|
orientation to week 2
|
|
Continuous heart rate
Lasso di tempo: orientation to week 2.5
|
Polar Version OH1
|
orientation to week 2.5
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Modified Borg Scale
Lasso di tempo: orientation to week 1
|
2-items, 1 (very light activity) -10 (maximal effort)
|
orientation to week 1
|
|
Modified Borg Scale
Lasso di tempo: orientation to week 1.5
|
2-items, 1 (very light activity) -10 (maximal effort)
|
orientation to week 1.5
|
|
Modified Borg Scale
Lasso di tempo: orientation to week 2
|
2-items, 1 (very light activity) -10 (maximal effort)
|
orientation to week 2
|
|
Modified Borg Scale
Lasso di tempo: orientation to week 2.5
|
2-items, 1 (very light activity) -10 (maximal effort)
|
orientation to week 2.5
|
|
Yoga Self Efficacy Scale
Lasso di tempo: Baseline
|
12-item, 9 point Likert scale, higher score, more self-efficacious
|
Baseline
|
|
Stanford Leisure-Time Activity Categorical Item
Lasso di tempo: Baseline
|
Score of 1-6, higher is better outcome
|
Baseline
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Samantha M Harden, PhD, Virginia Polytechnic Institute and State University
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- 21-325
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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