- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07638267
Does Style Matter: Comparison of Moderate- to Low-intensity Styles of Yoga
Effects of a Single Evening Session of Vinyasa Yoga to Gentle Yoga on Sleep and Cardiovascular Health in Adults
The goal of this clinical trial is to learn if yoga works to improve sleep and heart health in adults with and without insomnia disorder. The main questions it aims to answer are:
- Does the style of yoga impact participants heart health overnight?
- Does the style of yoga improve participants sleep following a single session? Researchers will compare adults with insomnia disorder to adults with healthy sleep .
Participants will:
- Complete a moderate-intensity yoga practice, a low-intensity intensity yoga practice, and a quiet rest period while watching a nature documentary in the evening on three separate evenings
- Participants will have their sleep and heart health measured using a watch and heart rate monitor overnight following each visit
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
This study investigates how two different styles of yoga, vinyasa yoga and gentle yoga, impact sleep and heart health in adults with and without insomnia. Insomnia, a common sleep disorder, increases the risk of heart disease, the leading cause of death worldwide. Recently, the American Heart Association identified poor sleep as a key factor in maintaining heart health, yet there is limited research on therapies that can simultaneously improve both sleep and cardiovascular function. By examining the immediate effects of a single evening session of yoga, this study aims to determine if yoga could serve as a practical, complementary approach to managing sleep and heart health.
Using a three-arm randomized crossover design, the study includes 42 participants, aged 18-40, who are either good sleepers or have diagnosed insomnia. Each participant will complete three sessions: one of vinyasa yoga, one of gentle yoga, and a non-active control session, with each session separated by a 72-hour washout period to avoid carryover effects. The yoga sessions will be standardized to 60 minutes and take place in the evening, approximately 4-6 hours before bedtime, under the supervision of a trained research staff.
The study has three main goals. First, examine whether different yoga styles influence heart function during sleep by measuring heart rate variability (HRV), a marker of nervous system balance that reflects the body's ability to regulate stress and relaxation. The investigators hypothesize that both yoga styles will improve HRV in people with insomnia more than in healthy sleepers. Second, to determine if vinyasa or gentle yoga improves sleep quality-measured by sleep efficiency (the percentage of time in bed spent asleep), total sleep time, and self-reported sleep quality-in adults with insomnia compared to those without sleep problems. Lastly, measure the impact of yoga on blood vessel function using flow-mediated dilation (FMD), a test that measures how well blood vessels expand in response to increased blood flow, with the expectation that vinyasa yoga's moderate intensity will provide greater immediate benefits compared to gentle yoga.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Florida
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Orlando, Florida, Stati Uniti, 32816
- University of Central Florida
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Descrizione
Inclusion Criteria:
- Adults 18-40 years
- Insufficiently inactive define by the L-CAT (responses below public health physical activity guidelines)
- Physical activity is not contraindicated (i.e., no affirmative responses on the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+)
- Adults with diagnosed insomnia disorder and score ≥ 10 on the Insomnia Severity Index
- Good sleeps a score < 10 (no history of sleep disorder)
- Basic understanding of yoga poses
- Access to a smart device (such as a smartphone or tablet)
Exclusion Criteria:
- Regular yoga practice (> 60 minutes per week)
- Any diagnosed medical condition requiring medical clearance determined 'Yes' response on questions pertaining to a present medical condition(s) via PAR-Q+. This includes, but is not limited to, uncontrolled cardiovascular, metabolic, respiratory, musculoskeletal, neurological, or mental health conditions; recent stroke or concussion; active cancer treatment; and any combination of medical conditions that pose a health risk without physician supervision. All "yes" responses on the PAR-Q+ will be evaluated, and individuals requiring clearance will not be eligible to participate.
- Physical limitations and/or mobility restrictions (such as bone, joint, or soft tissue such as muscle, ligament, or tendon that could be made worse by becoming more physically active) via PAR-Q+
- Untreated major psychiatric disorders (e.g. major depression, bipolar disorder, schizophrenia)
- Elevated risk for sleep apnea (i.e., STOP-Bang score ≥ 5)
- Any other sleep disorders other than insomnia (e.g., sleep apnea, restless legs syndrome, circadian rhythm disorder, etc.)
- Current treatment for insomnia (e.g., hypnotic medications, cognitive behavioral therapy for insomnia, etc.)
- Current medications that affect heart or blood pressure (i.e., anti-depressants, beta-blockers, etc.)
- Current or planned pregnancy within the next 3 months
- Overnight shift work defined as regularly working anytime between 00:00 and 6:00am
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: vinyasa yoga
60 minute moderate-intensity yoga session
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Participants will follow a pre-recorded standardized sequence that includes a person demonstrating each sequence and provides verbal cues for the vinyasa yoga session.
The 60-minute vinyasa yoga protocol incorporated standing, seated, and supine postures and included the following order of sequences: integration, sun salutations, crescent lunge series, balancing, standing, back bending, and restorative series.
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Sperimentale: gentle yoga
60 minute low-intensity yoga session
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Participants will follow a pre-recorded standardized sequence that includes a person demonstrating each sequence and provides verbal cues for the gentle yoga session.
This sequence focuses primarily on seated and supine postures and is designed to be accessible, safe, and restorative.
All poses are low-impact and supported using yoga blocks to promote comfort and reduce physical strain.
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Altro: Control Condition
60-minute non-active control condition
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The non-active control session, participants will complete a quiet rest period while watching a nature documentary.
The film is educational in nature and has been carefully selected to avoid any graphic, distressing, offensive, or psychologically sensitive content.
It is commercially available and rated G for general audiences.
Participants will be asked to remain seated and refrain from the use of electronic devices.
A staff member will remain present to ensure participants following procedures.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in nocturnal root mean square of successive difference between normal heartbeats (RMSSD) heart rate variability (HRV)
Lasso di tempo: Overnight immediately after each experimental sessions (vinyasa yoga, gentle yoga, non-active control) for a total of 3 separate nights.
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Nocturnal root mean square of successive difference between normal heartbeats will be assessed immediately after each experimental session for 1 night; a higher value indicates better cardiovascular health
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Overnight immediately after each experimental sessions (vinyasa yoga, gentle yoga, non-active control) for a total of 3 separate nights.
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in sleep efficiency
Lasso di tempo: Overnight immediately after each experimental sessions (vinyasa yoga, gentle yoga, non-active control) for a total of 3 separate nights.
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Actigraphy-assessed sleep efficiency will be measured overnight immediately after each experimental sessions (vinyasa yoga, gentle yoga, non-active control) for a total of 3 separate nights.
Values are represented as a percentage, with higher values indicating better sleep efficiency
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Overnight immediately after each experimental sessions (vinyasa yoga, gentle yoga, non-active control) for a total of 3 separate nights.
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Change in total sleep time
Lasso di tempo: Overnight immediately after each experimental sessions (vinyasa yoga, gentle yoga, non-active control) for a total of 3 separate nights.
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Actigraphy-assessed total sleep time will be immediately assessed after each experimental sessions for 1 night.
Total sleep time will be reported in hours.
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Overnight immediately after each experimental sessions (vinyasa yoga, gentle yoga, non-active control) for a total of 3 separate nights.
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Change in wake after sleep onset
Lasso di tempo: Overnight immediately after each experimental sessions (vinyasa yoga, gentle yoga, non-active control) for a total of 3 separate nights.
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Actigraphy-assessed wake after sleep onset will be immediately assessed after each experimental sessions for 1 night.
Wake after sleep onset will be presented as minutes, the higher the values the more time spent awake during the sleep period.
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Overnight immediately after each experimental sessions (vinyasa yoga, gentle yoga, non-active control) for a total of 3 separate nights.
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Change in sleep quality
Lasso di tempo: The following morning after each experimental sessions (vinyasa yoga, gentle yoga, non-active control) for a total of 3 separate mornings.
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Diary-assessed sleep quality will be immediately assessed after each experimental sessions the following morning, on 3 seperate mornings.
The sleep diary will be the Expanded Consensus Sleep Diary for Evening.
Participants will rate their quality of sleep (ranging from 1 ['very poor'] to 5 ['very good'], higher scores indicating better sleep quality.
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The following morning after each experimental sessions (vinyasa yoga, gentle yoga, non-active control) for a total of 3 separate mornings.
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Change in nocturnal heart rate
Lasso di tempo: Overnight immediately after each experimental sessions (vinyasa yoga, gentle yoga, non-active control) for a total of 3 separate nights.
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Nocturnal heart rate will be assessed immediately after each experimental session for 1 night (3 seperate nights); a lower resting nocturnal heart rate value indicates better cardiovascular health
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Overnight immediately after each experimental sessions (vinyasa yoga, gentle yoga, non-active control) for a total of 3 separate nights.
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Change in systolic blood pressure
Lasso di tempo: pre- , immediate-post, and 60-minute post following each experimental session (vinyasa yoga, gentle yoga, non-active control)
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Systolic blood pressure will be measured pre- , immediate-post, and 60-minute post following each experimental session
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pre- , immediate-post, and 60-minute post following each experimental session (vinyasa yoga, gentle yoga, non-active control)
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Change in diastolic blood pressure
Lasso di tempo: pre- , immediate-post, and 60-minute post following each experimental session (vinyasa yoga, gentle yoga, non-active control)
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Diastolic blood pressure will be measured pre- , immediate-post, and 60-minute post following each experimental session
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pre- , immediate-post, and 60-minute post following each experimental session (vinyasa yoga, gentle yoga, non-active control)
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Change in heart rate
Lasso di tempo: pre- , immediate-post, and 60-minute post following each experimental session (vinyasa yoga, gentle yoga, non-active control)
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heart rate will be measured pre- , immediate-post, and 60-minute post following each experimental session
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pre- , immediate-post, and 60-minute post following each experimental session (vinyasa yoga, gentle yoga, non-active control)
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Change in root mean square of successive difference between normal heartbeats
Lasso di tempo: pre- , immediate-post, and 60-minute post following each experimental session (vinyasa yoga, gentle yoga, non-active control)
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Root mean square of successive difference between normal heartbeats will be measured pre- , immediate-post, and 60-minute post following each experimental session
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pre- , immediate-post, and 60-minute post following each experimental session (vinyasa yoga, gentle yoga, non-active control)
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Change in flow-mediated dilation
Lasso di tempo: pre- , 60-minute post, and delayed-posted (morning after) following each experimental session (vinyasa yoga, gentle yoga, non-active control)
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Flow-mediated dilation will be measured pre- , 60-minute post, and delayed-post (morning after) following each experimental session
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pre- , 60-minute post, and delayed-posted (morning after) following each experimental session (vinyasa yoga, gentle yoga, non-active control)
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Change in acute anxiety symptoms
Lasso di tempo: Immediately pre- and post-experimental session (vinyasa yoga, gentle yoga, non-active control)
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Acute anxiety symptoms will be measured using the State-Trait Inventory 20-item.
Each item is rated on a 4-point scale ranging from 1 (not at all) to 4 (very much so).
Scores are summed for a total that ranges from 20-80; higher scores indicate greater symptoms of anxiety.
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Immediately pre- and post-experimental session (vinyasa yoga, gentle yoga, non-active control)
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Change in mood
Lasso di tempo: Immediately pre- and post-experimental session (vinyasa yoga, gentle yoga, non-active control)
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Acute changes in mood will be measured using the Profile of Mood States brief form.
This will assess the feelings of tension, depressed mood, energy, fatigue, and total mood disturbances based on how the participant feels right now using a 5-point Likert scale ranging from 0 "not at all" to 4 "extremely
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Immediately pre- and post-experimental session (vinyasa yoga, gentle yoga, non-active control)
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Collaboratori e investigatori
Sponsor
Collaboratori
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Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
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
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- STUDY00007288
- 5523 (Altro numero di sovvenzione/finanziamento: ACSM Foundation)
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
Periodo di condivisione IPD
Criteri di accesso alla condivisione IPD
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
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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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