Yoga Empowers Seniors Study (YESS)
14. november 2016 oppdatert av: George Salem, University of Southern California
Safe and Effective Yoga Prescription of Seniors: Biomechanical Considerations
This is an Intervention Development Study (IDS) to quantify the physical demands (using biomechanical investigation) of a 2-phase (beginning & intermediate), 32-week yoga program designed for community-dwelling older adults.
Additionally, the IDS will explore the adherence and adverse events of participation in the program.
Data from the IDS will be used to develop evidenced-based yoga programs, which the investigators postulate will be associated with fewer musculoskeletal side effects compared to non-evidence based yoga programs.
The investigators also postulate that evidenced-based tailoring of yoga for seniors will enhance adherence and efficacy.
The programs developed during this IDS will be tested in an expanded, Phase II, Randomized Controlled Trial.
Studieoversikt
Detaljert beskrivelse
Yoga is currently being recommended to restore and preserve strength, flexibility, balance, & physical capacity in older adults; however, our clinical trial experiences suggest that without proper evidenced-based prescription, Yoga participation can be ineffective or even injurious for seniors.
To address this lack of evidence-based knowledge, the proposed IDS will: 1) quantify the physical demands of a 32-wk Yoga program designed for independent ambulatory seniors; 2) characterize the relations between these demands and participant physical characteristics; 3) examine the adherence, efficacy, & safety of the program; and 4) characterize the relations among reported adverse events, baseline participant characteristics, and Yoga physical demands.
Studietype
Intervensjonell
Registrering (Faktiske)
27
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
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California
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Los Angeles, California, Forente stater, 90024
- UCLA
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
65 år og eldre (Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Community dwelling men and women volunteers, aged 65 years or older.
Exclusion Criteria:
Safety exclusions:
--the following safety exclusions are adopted in order to decrease potential *cardiovascular
- musculoskeletal
- neurological risks to the participants:
- active angina
- uncontrolled hypertension (SBP greater than 160 or DBP greater than 90)
- high resting pulse or respiratory rate (HR >90 or RR>24 after 5 minutes seated)
- unstable asthma or exacerbated COPD
- cervical spine instability or other significant neck injury
- rheumatoid arthritis
- unstable ankle, knee, hip, shoulder, elbow, or wrist joints
- hemiparesis or paraparesis
- movement disorders (e.g. Parkinson's disease), peripheral neuropathies, stroke with residual deficits, severe vision or hearing problems
- walker or wheelchair use
- insufficient hearing to permit safety in a yoga group setting
- not able to attend in-person classes
- has not had check-up by regular provider within 12 months (if not taking any prescription medications) or in the past 6 months (if any regular medicines taken); cannot pass specific movement safety tests (tests described in section on screening visits, below)
Feasibility/adherence exclusions:
- unable to understand their commitment to the project, (laboratory visits & regular program participation)
- cognitive limitations significant enough to preclude informed consent or to raise concerns about participation safety
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: yoga
32 weeks of yoga training
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yoga classes 2 times per week for 32 weeks
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
peak joint moments
Tidsramme: difference from baseline to 16 wk
|
These are the torques produced by the muscles during performance of the yoga poses
|
difference from baseline to 16 wk
|
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peak joint moments
Tidsramme: difference from 16 wk to 32 wk
|
These are the torques produced by the muscles during performance of the yoga poses
|
difference from 16 wk to 32 wk
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
time to stand and sit from a chair 5 times
Tidsramme: baseline, 16 and 32 weeks
|
In the 5-Repetition Chair Stand Test, we record the time it takes for a participant to repeatedly stand and sit on a chair 5 times.
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baseline, 16 and 32 weeks
|
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number of heel-rise repetitions
Tidsramme: baseline, 16 and 32 weeks
|
The Heel-Rise Test is a measure of plantar-flexion endurance.
Here, we record the number of full range-of-motion, heel-rise repetitions the participants can complete before fatigue.
|
baseline, 16 and 32 weeks
|
|
Time to complete Up & Go test
Tidsramme: baseline, 16 and 32 weeks
|
In the Up & Go Test, a measure of mobility, we record the number of seconds it takes to rise from a chair, walk 8 feet, return and sit in the chair.
|
baseline, 16 and 32 weeks
|
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Number of marching steps completed within 2 minutes
Tidsramme: baseline, 16 and 32 weeks
|
In the 2-Minute Step Test, a measure stepping endurance, we record the number of complete marching steps the participant can perform within a 2-minute period
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baseline, 16 and 32 weeks
|
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Distance participant can reach forward from a sitting position
Tidsramme: baseline, 16 and 32 weeks
|
The sit and reach test measures overall sagittal-plane flexibility.
The participant is asked to reach as far as possible toward their dominant limb while remaining seated.
|
baseline, 16 and 32 weeks
|
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Distance between fingers of opposing hands as participant attempts to touch fingers while reaching posteriorly.
Tidsramme: baseline, 16 and 32 weeks
|
The Back Scratch Test measures upper extremity flexibility.
Here the distance between finger-tips is recorded as the participant reaches posteriorly and attempts to touch opposing hands.
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baseline, 16 and 32 weeks
|
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Maximum passive wrist flexion, extension, radial-deviation, and ulnar-deviation, range of motion (in degrees).
Tidsramme: baseline, 16 and 32 weeks
|
These tests measure the range of motion of the wrist in the sagittal and frontal planes.
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baseline, 16 and 32 weeks
|
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Maximum height participant can reach while standing
Tidsramme: baseline, 16 and 32 weeks
|
Here we quantify the maximum vertical height participants can reach while standing.
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baseline, 16 and 32 weeks
|
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Maximum distance participant can reach forward while standing
Tidsramme: baseline, 16 and 32 weeks
|
THe Maximum Forward Reach test is a measure of strength and flexibility.
Here we record the maximum distance the participant can reach forward while standing.
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baseline, 16 and 32 weeks
|
|
stride length during walking
Tidsramme: baseline, 16 and 32 weeks
|
Here we quantify the stride length of participants during walking at a self-selected pace.
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baseline, 16 and 32 weeks
|
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Maximum joint angle
Tidsramme: baseline, 16 and 32 weeks
|
Here we quantify the maximum joint angles of the ankle, knee, hip, trunk, shoulder, elbow, and wrist during performance of the yoga poses.
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baseline, 16 and 32 weeks
|
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Sway distance of the center of pressure
Tidsramme: baseline, 16 and 32 weeks
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Here we quantify the movement of the center of pressure as participants stand as still as possible
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baseline, 16 and 32 weeks
|
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Electromyographic activity of muscles
Tidsramme: baseline, 16 and 32 weeks
|
Here we record the electromyographic activity of the Anterior Deltoid, Triceps surae, Obliques, Rectus Abdominus, Erector Spinae, Gluteus Maximus, Lateral Hamstrings, Vastus Lateralis, Gastrocnemius, and Gluteus Medius, muscles during performance of the yoga poses.
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baseline, 16 and 32 weeks
|
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SF-36 score
Tidsramme: baseline and 36 weeks
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Health related quality of life and mood will be assessed with the RAND Short Form-36 (Hays, 1993).
The SF-36 includes sub-scales that measure: 1) health-related limitations in physical function; 2) health-related limitations in role and in social function; 3) emotional function (including positive and negative mood states); 4) pain.
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baseline and 36 weeks
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: George Salem, PhD, University of Southern California
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. juli 2009
Primær fullføring (Faktiske)
1. april 2011
Studiet fullført (Faktiske)
1. april 2011
Datoer for studieregistrering
Først innsendt
20. juli 2011
Først innsendt som oppfylte QC-kriteriene
4. august 2011
Først lagt ut (Anslag)
5. august 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
16. november 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
14. november 2016
Sist bekreftet
1. november 2016
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 1R01AT004869-01 (U.S. NIH-stipend/kontrakt)
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