Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

Fit & Active Seniors Trial (FAST)

21 lutego 2017 zaktualizowane przez: Edward McAuley, University of Illinois at Urbana-Champaign

Influence of Fitness on Brain and Cognition II

The investigators propose to test the hypothesis that a six-month intervention of combined fitness and cognitive training in the form of dancing will have a significant positive effect on a variety of executive control and memory processes as well as brain structure and function as compared to a non-aerobic strength and balance control/comparison group. Additionally, these two groups will be compared to walking groups in which one of the walking groups will also be provided with a daily, liquid, milk-based nutritional supplement.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

Our previous trial (known as HALT, Healthy Active Lifestyle Trial) suggests that improvements in aerobic fitness have beneficial effects on cognitive function that are rather specific. That is, improvements in aerobic fitness appear to result in improvements in executive control processes such as scheduling, planning, coordination, inhibition, and working memory - some of the very cognitive abilities most affected during aging. Indeed, executive control processes and the prefrontal and frontal regions which support them have shown substantial and disproportionate age-related declines. The main hypothesis that the investigators test in the present project is that such deficits may be particularly benefited by improvements in aerobic fitness combined with cognitive training in the form of dance. Additionally, we will compare the outcomes of these interventions with an aerobic condition (walking) group and an aerobic condition (walking) group that also is provided with a daily nutritional supplement (walking + nutrition). The investigators will examine the relationship between aerobic fitness, physical activity, cognitive status, and brain function with this six-month aerobic training intervention study. The investigators will collect psychosocial data and functional fitness data to assess other relevant changes in psychological and physical function brought about by exercise training. Healthy, non-active older adults (60 to 79 years of age) will be recruited from the local community. Half One quarter of the older adults will be randomly assigned to an aerobic/cognitive combination group (dance), one quarter will be while the remaining half of the older adults will be randomly assigned to a non-aerobic control group (stretching, strengthening, and stability), one quarter will be assigned to the walking group, and one quarter will be assigned to the walking + nutrition group. The exercise interventions will be conducted by trained exercise staff. The participants will be assessed before and after the intervention (6 months). Assessments will include (a) cardiorespiratory testing, (b) physical activity monitoring (c) performance on neurocognitive tests of executive and non-executive function (d) measures of brain activation (fMRI) during cognitive tasks in a 3.0 tesla MRI system (e) a battery of psychosocial questionnaires (f) functional performance measures and (g) a mock street walking task.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

247

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Stany Zjednoczone
    • Illinois
      • Urbana, Illinois, Stany Zjednoczone, 61801
        • University of Illinois

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

60 lat do 79 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  • 60-79 years of age
  • Low-active: zero to two days of physical activity (> 30 minutes per day) per week in previous six months.
  • Personal physician's examination and/or consent to participate in testing and exercise intervention
  • Successful completion of graded exercise test without evidence of cardiac abnormalities or responses which are likely to be exacerbated by exercise. This decision will be made by the attending cardiologist.
  • Adequate responses to the Telephone Interview of Cognitive Status (TICS-M) questionnaire
  • Corrected (near and far) acuity of 20/40 or better in both eyes and no diagnosis of color-blindedness
  • Initial depression score on GDS-15 (Geriatric Depression Scale) below clinical level (> 10)
  • No presence of implanted devices or metallic bodies above the waist
  • No history of brain surgery that involved removal of brain tissue
  • Right-handed
  • No history of stroke or Transient ischemic attack(TIA)
  • Intention to remain in the local area for the duration of the intervention or testing period
  • English fluency

Exclusion Criteria:

  • Below 60 years of age or above 80 years of age at beginning of intervention
  • Self-reported regular physical activity of more than 2 times per week in last six months
  • Non-consent of physician
  • Evidence of abnormal cardiac responses or conditions during graded exercise testing
  • Inadequate responses to the Telephone Interview of Cognitive Status (TICS-M) questionnaire (<20)
  • Uncorrectable (near and far) acuity of greater than 20/40 in either eye and/or color-blindness
  • Depression score on GDS-15 indicative of clinical depression (≤ 10)
  • Presence of any implanted devices above the waist i.e. cardiac pacemaker or auto-defibrillators; neural pacemaker; aneurysm clips in the Central Nervous System(CNS); cochlear implant; metallic bodies in the eye or CNS; any form of wires or metal devices that may concentrate radiofrequency fields
  • History of brain surgery that involved removal of brain tissue
  • Left-handed
  • History of Stroke or TIA
  • Intent to move or be away from the area for an extended period of time (i.e. > 3 weeks) during the intervention or testing period
  • Inability to communicate effectively in English

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Dance
Participants will be instructed in various forms of dances such as ballroom, swing, waltz, folk, and English country.
Behawioralne: Dance Group
Participants will be instructed and learn various forms of dance (i.e. English country, folk, ballroom) and will be led by trained dance instructors and exercise specialists. Participants will for one-hour sessions and meet three times per week for six months.
Inne nazwy:
  • Fit & Active Seniors Trial
Aktywny komparator: Strengthening, Stability, Stretching
Participants will be instructed in various forms of strength, stretching (flexibility) and stability (balance)exercises.
Behawioralne: Strength, Stretching, Stability
Exercises focusing on strength, flexibility and balance will be performed at one-hour sessions held three times per week for six months. Classes are led by trained exercise specialists.
Inne nazwy:
  • Fit & Active Seniors Trial
Eksperymentalny: Walking
Participants in this moderate aerobic conditioning exercise program will be instructed in a walking program that focuses on having them walk within their target heart rate.
Behawioralne: Walking
Participants in this moderate aerobic conditioning exercise program will be instructed in a walking program that focuses on having them walk within their target heart rate. They will be provided with heart rate monitors and pedometers for accurate record keeping. They will meet three times per week for one hour for six months. Warm up and cool down stretches will be a part of each walking session and sessions will be monitored and led by trained exercise specialists.
Eksperymentalny: Walking + Nutritional Supplement
Participants in this moderate aerobic conditioning exercise program will be instructed in a walking program that focuses on having them walk within their target heart rate. These participants will also be provided with a daily nutritionally balanced liquid, milk-based formula.
Behawioralne: Walking
Participants in this moderate aerobic conditioning exercise program will be instructed in a walking program that focuses on having them walk within their target heart rate. They will be provided with heart rate monitors and pedometers for accurate record keeping. They will meet three times per week for one hour for six months. Warm up and cool down stretches will be a part of each walking session and sessions will be monitored and led by trained exercise specialists.
Behawioralne: Walking + Nutrition
Participants in this moderate aerobic conditioning exercise program will be instructed in a walking program that focuses on having them walk within their target heart rate. They will be provided with heart rate monitors and pedometers for accurate record keeping. They will meet three times per week for one hour for six months. Warm up and cool down stretches will be a part of each walking session and sessions will be monitored and led by trained exercise specialists. These participants will also be provided with a daily nutritionally balanced liquid, milk-based supplement formula.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change from baseline to month six in brain structure and function
Ramy czasowe: Baseline and six months
Participants will undergo a neuropsychological battery of tasks assessing memory, attention and decision-making at baseline and month six. They will also undergo an fMRI during which images of brain structure and function (completing tasks during image collection) will be compared from baseline to month six.
Baseline and six months
Change from baseline to month six in cardiorespiratory fitness
Ramy czasowe: Baseline and six months
We will conduct graded maximal exercise treadmill test measuring peak oxygen consumption at baseline and six months.
Baseline and six months

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change from baseline to month six: Quality of life
Ramy czasowe: Baseline and six months
We will assess multiple indicators of Quality of Life such as: depression; physical and mental health status; satisfaction with life; etc.
Baseline and six months
Change from baseline to month six: Self-efficacy
Ramy czasowe: Baseline, three weeks and six months
We will examine the extent to which self-efficacy (e.g. barriers, adherence, function) changes as a function of participation in regular group physical activity training.
Baseline, three weeks and six months
Program adherence over six month intervention
Ramy czasowe: Six months
We will monitor attendance during the six-month intervention(program meets three days per week).
Six months
Change from baseline to month six: Physical function
Ramy czasowe: Baseline and six months
We will conduct functional fitness testing including tests of balance, strength, mobility and flexibility at baseline and six months.
Baseline and six months
Change from baseline to month six: Psychosocial Outcomes
Ramy czasowe: Baseline and six months
We will assess changes in psychosocial function (e.g. self-esteem; social support; anxiety) by written questionnaires.
Baseline and six months

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of Illinois at Urbana-Champaign

Śledczy

  • Główny śledczy: Arthur F Kramer, PhD, University of Illinois at Chicago

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 sierpnia 2011

Zakończenie podstawowe (Rzeczywisty)

1 grudnia 2014

Ukończenie studiów (Rzeczywisty)

1 grudnia 2014

Daty rejestracji na studia

Pierwszy przesłany

18 sierpnia 2011

Pierwszy przesłany, który spełnia kryteria kontroli jakości

11 listopada 2011

Pierwszy wysłany (Oszacować)

16 listopada 2011

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

23 lutego 2017

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

21 lutego 2017

Ostatnia weryfikacja

1 lutego 2017

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Inne numery identyfikacyjne badania

  • R37AG025667 (Grant/umowa NIH USA)
  • 392 (Center for Nutrition, Learning and Memory UIUC)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Dance Group

Wyszukaj podobne próby

Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

CROs by country

CROs in Uganda

Warunki

Rzadkie choroby

Interwencje lekowe

Suplementy diety

Sponsor / Współpracownicy

Lokalizacje

Subskrybuj