- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT05184673
Moderate Aerobic Activity Through Yoga (MAT)
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
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Virginia
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Blacksburg, Virginia, Forente stater, 24060
- Samantha M Harden
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Aktiv 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
|
Aktiv 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
|
Aktiv 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
|
Aktiv 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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Continuous heart rate
Tidsramme: orientation to week 0 (baseline)
|
Polar Version OH1
|
orientation to week 0 (baseline)
|
Continuous heart rate
Tidsramme: orientation to week 1
|
Polar Version OH1
|
orientation to week 1
|
Continuous heart rate
Tidsramme: orientation to week 1.5
|
Polar Version OH1
|
orientation to week 1.5
|
Continuous heart rate
Tidsramme: orientation to week 2
|
Polar Version OH1
|
orientation to week 2
|
Continuous heart rate
Tidsramme: orientation to week 2.5
|
Polar Version OH1
|
orientation to week 2.5
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Modified Borg Scale
Tidsramme: orientation to week 1
|
2-items, 1 (very light activity) -10 (maximal effort)
|
orientation to week 1
|
Modified Borg Scale
Tidsramme: orientation to week 1.5
|
2-items, 1 (very light activity) -10 (maximal effort)
|
orientation to week 1.5
|
Modified Borg Scale
Tidsramme: orientation to week 2
|
2-items, 1 (very light activity) -10 (maximal effort)
|
orientation to week 2
|
Modified Borg Scale
Tidsramme: orientation to week 2.5
|
2-items, 1 (very light activity) -10 (maximal effort)
|
orientation to week 2.5
|
Yoga Self Efficacy Scale
Tidsramme: Baseline
|
12-item, 9 point Likert scale, higher score, more self-efficacious
|
Baseline
|
Stanford Leisure-Time Activity Categorical Item
Tidsramme: Baseline
|
Score of 1-6, higher is better outcome
|
Baseline
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Samantha M Harden, PhD, Virginia Polytechnic Institute and State University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Plan for individuelle deltakerdata (IPD)
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Legemiddel- og utstyrsinformasjon, studiedokumenter
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