- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01411059
Yoga Empowers Seniors Study (YESS)
14 november 2016 uppdaterad 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.
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
27
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
California
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Los Angeles, California, Förenta staterna, 90024
- UCLA
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
65 år och äldre (Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: yoga
32 weeks of yoga training
|
yoga classes 2 times per week for 32 weeks
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
peak joint moments
Tidsram: difference from baseline to 16 wk
|
These are the torques produced by the muscles during performance of the yoga poses
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difference from baseline to 16 wk
|
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peak joint moments
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
time to stand and sit from a chair 5 times
Tidsram: 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
Tidsram: 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
Tidsram: 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.
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baseline, 16 and 32 weeks
|
|
Number of marching steps completed within 2 minutes
Tidsram: 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
|
|
Distance participant can reach forward from a sitting position
Tidsram: 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
|
|
Distance between fingers of opposing hands as participant attempts to touch fingers while reaching posteriorly.
Tidsram: 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
|
|
Maximum passive wrist flexion, extension, radial-deviation, and ulnar-deviation, range of motion (in degrees).
Tidsram: 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
|
|
Maximum height participant can reach while standing
Tidsram: 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
|
|
Maximum distance participant can reach forward while standing
Tidsram: 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.
|
baseline, 16 and 32 weeks
|
|
stride length during walking
Tidsram: baseline, 16 and 32 weeks
|
Here we quantify the stride length of participants during walking at a self-selected pace.
|
baseline, 16 and 32 weeks
|
|
Maximum joint angle
Tidsram: 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
Tidsram: baseline, 16 and 32 weeks
|
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
|
|
Electromyographic activity of muscles
Tidsram: 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
Tidsram: baseline and 36 weeks
|
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.
|
baseline and 36 weeks
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Utredare
- Huvudutredare: George Salem, PhD, University of Southern California
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 juli 2009
Primärt slutförande (Faktisk)
1 april 2011
Avslutad studie (Faktisk)
1 april 2011
Studieregistreringsdatum
Först inskickad
20 juli 2011
Först inskickad som uppfyllde QC-kriterierna
4 augusti 2011
Första postat (Uppskatta)
5 augusti 2011
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
16 november 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
14 november 2016
Senast verifierad
1 november 2016
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- 1R01AT004869-01 (U.S.S. NIH-anslag/kontrakt)
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