- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT04314921
10-week Yoga Practice Effect on Cognitive and Motor Function in Older Adults (BDNF)
10-week Yoga Practice Effect in Older Adults
Thirty-three healthy elderly people, who were classified into two age groups, participated in this study. All participants had not practiced yoga before and were asked not to perform any sports activities while the research was ongoing. In the experimental group, participants (n = 18) had to participate in 10 weeks of yoga classes. In the control group, participants (n = 15) did not perform any exercises or other changes in their daily living life.
Experimental measurements: Brunel, PSS-14 and HAD questionnaires
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Kaunas, Litwa, 44221
- Lithuanian Sports Unviersity
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- age, from 60 years old
- a statement by a local family physician about general good physical health
- never tired to practice yoga before
Exclusion Criteria:
- cardiovascular diseases
- musculoskeletal system diseases (osteoporosis, osteochondrosis, hernias)
- neurodegenerative diseases
- oncological diseases
- glaucoma
- injuries and surgeries in last 3 years
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: 10-week Yoga
Eighteen healthy elderly people, who were classified into two age groups, participated in this study.
All participants had not practiced yoga before and were asked not to perform any sports activities while the research was ongoing.
In the experimental group, participants (n = 18) had to participate in 10 weeks of yoga classes.
In the control group, participants (n = 15) did not perform any exercises or other changes in their daily living life.
All experimental group subjects participated in Himalayan yoga classes, which lasted 10 weeks: 2 times per week, 90 min per session.
Yoga classes were conducted by 16-year-old qualified yoga instructor from Yoga Academy, Kaunas.
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10-week yoga sessions, 2 times per week, 90 min per session.
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Brak interwencji: Control
In the control group, participants (n = 15) did not perform any exercises or other changes in their daily living life.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Brunel mood scale (BRUMS)
Ramy czasowe: 10 weeks
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The Lithuanian translated version of the Brunel Mood Scale (BRUMS) was used in the present study.
It was based on the originally developed to serve as a brief measure of mood before and after yoga intervention.
The BRUMS (1) scale has 24 items arranged into six subscales: anger, confusion, depression, fatigue, tension and vigor.
Each subscale has a numerical rating scale (0 = not at all, 1 = a bit, 2 = moderate, 3 = enough; 4 = extremely) from which research participant select the one best represents at that time.
The results within subscale is summed and a score range from 0 to 16
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10 weeks
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Hospital anxiety and depression scale (HADS)
Ramy czasowe: 10 weeks
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To determine the level of anxiety and depression of subjects was used HADS scale.
The scale consists of totally 14 questions with the answers valued from 0 to 3. Half of questions addressed to estimate anxiety and rest - depression.
The total scoring and conclusion for the both categories of questions: 0-7 = Normal; 8-10 = Borderline abnormal (borderline case); 11-21 = Abnormal (case)
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10 weeks
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Perceived stress scale -14
Ramy czasowe: 10 weeks
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The purpose of this scale is to assess the degree of stress in subjects' lives.
It consists of questions about the frequency of feeling and thoughts during the past time period.
Potential answers: 0-never; 1-almost never; 2-sometimes; 3-fairly often and 4-very often.
The scores are obtained by reversing the scores on the four positive items: for example, 0=4, 1=3, 2=2, etc. and then summing across all items.
Scores for the 14-item form range from 0 to 56, with higher scores indicating greater perceived stress
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10 weeks
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Human Free BDNF
Ramy czasowe: 10 weeks
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Venous blood samples from median antecubital vein were collected in 5 ml vacuum tubes with a gel separator and was separated by centrifugation (15 min at 1200g) to make blood serum.
Samples were aliquoted and stored at -800C until analysis.
The serum concentration of Human Free BDNF was measured using an enzyme-linked immunoassay kit (R&D Systems, Minneapolis, USA)
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10 weeks
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Measurement of cognitive functions
Ramy czasowe: 10 weeks
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Automated Neuropsychological Assessment Metrics Version 4 (ANAM-4; Vista Life, USA) was used to measure neurocognitive skills: mental flexibility, verbal working memory, inhibition control, visuospatial processing.
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10 weeks
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Psychomotor function evaluation
Ramy czasowe: 10 weeks
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Participants were assessed by Dynamic Parameter Analyzer (DPA-1).
Its measure motor functions: accuracy, reaction speed-accuracy.
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10 weeks
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Heart rate variability
Ramy czasowe: 10 weeks
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R-R intervals were recorded using a Polar H7 sensor with a chest strap (Kempele, Finland).
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10 weeks
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Balance procedure
Ramy czasowe: 10 weeks
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Postural sway activity was measured by a posturography method with a single piezoelectric force plate (Kistler, Slimline System 9286, Switzerland).
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10 weeks
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Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
- LithuanianSportsU-3
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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