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Fit & Active Seniors Trial (FAST)

21. februar 2017 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

247

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Illinois
      • Urbana, Illinois, Forenede Stater, 61801
        • University of Illinois

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

60 år til 79 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Dance
Participants will be instructed in various forms of dances such as ballroom, swing, waltz, folk, and English country.
Adfærdsmæssigt: 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.
Andre navne:
  • Fit & Active Seniors Trial
Aktiv komparator: Strengthening, Stability, Stretching
Participants will be instructed in various forms of strength, stretching (flexibility) and stability (balance)exercises.
Adfærdsmæssigt: 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.
Andre navne:
  • Fit & Active Seniors Trial
Eksperimentel: 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.
Adfærdsmæssigt: 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.
Eksperimentel: 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.
Adfærdsmæssigt: 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.
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from baseline to month six in brain structure and function
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from baseline to month six: Quality of life
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Illinois at Urbana-Champaign

Efterforskere

  • Ledende efterforsker: Arthur F Kramer, PhD, University of Illinois at Chicago

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2011

Primær færdiggørelse (Faktiske)

1. december 2014

Studieafslutning (Faktiske)

1. december 2014

Datoer for studieregistrering

Først indsendt

18. august 2011

Først indsendt, der opfyldte QC-kriterier

11. november 2011

Først opslået (Skøn)

16. november 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. februar 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. februar 2017

Sidst verificeret

1. februar 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • R37AG025667 (U.S. NIH-bevilling/kontrakt)
  • 392 (Center for Nutrition, Learning and Memory UIUC)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Dance Group

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Betingelser

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Placeringer

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