Trial record 1 of 4 for:    Fit & Active Seniors Trial (FAST)
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Fit & Active Seniors Trial (FAST)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Edward McAuley, University of Illinois at Urbana-Champaign
ClinicalTrials.gov Identifier:
NCT01472744
First received: August 18, 2011
Last updated: May 14, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Aging
Behavioral: Dance Group
Behavioral: Strength, Stretching, Stability
Behavioral: Walking
Behavioral: Walking + Nutrition
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Influence of Fitness on Brain and Cognition II

Resource links provided by NLM:


Further study details as provided by University of Illinois at Urbana-Champaign:

Primary Outcome Measures:
  • Change from baseline to month six in brain structure and function [ Time Frame: Baseline and six months ] [ Designated as safety issue: No ]
    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.

  • Change from baseline to month six in cardiorespiratory fitness [ Time Frame: Baseline and six months ] [ Designated as safety issue: No ]
    We will conduct graded maximal exercise treadmill test measuring peak oxygen consumption at baseline and six months.


Secondary Outcome Measures:
  • Change from baseline to month six: Quality of life [ Time Frame: Baseline and six months ] [ Designated as safety issue: No ]
    We will assess multiple indicators of Quality of Life such as: depression; physical and mental health status; satisfaction with life; etc.

  • Change from baseline to month six: Self-efficacy [ Time Frame: Baseline, three weeks and six months ] [ Designated as safety issue: No ]
    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.

  • Program adherence over six month intervention [ Time Frame: Six months ] [ Designated as safety issue: No ]
    We will monitor attendance during the six-month intervention(program meets three days per week).

  • Change from baseline to month six: Physical function [ Time Frame: Baseline and six months ] [ Designated as safety issue: No ]
    We will conduct functional fitness testing including tests of balance, strength, mobility and flexibility at baseline and six months.

  • Change from baseline to month six: Psychosocial Outcomes [ Time Frame: Baseline and six months ] [ Designated as safety issue: No ]
    We will assess changes in psychosocial function (e.g. self-esteem; social support; anxiety) by written questionnaires.


Estimated Enrollment: 300
Study Start Date: August 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dance
Participants will be instructed in various forms of dances such as ballroom, swing, waltz, folk, and English country.
Behavioral: 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.
Other Name: Fit & Active Seniors Trial
Active Comparator: Strengthening, Stability, Stretching
Participants will be instructed in various forms of strength, stretching (flexibility) and stability (balance)exercises.
Behavioral: 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.
Other Name: Fit & Active Seniors Trial
Experimental: 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.
Behavioral: 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.
Experimental: 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.
Behavioral: 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.
Behavioral: 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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   60 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01472744

Locations
United States, Illinois
University of Illinois
Urbana, Illinois, United States, 61801
Sponsors and Collaborators
University of Illinois at Urbana-Champaign
Investigators
Principal Investigator: Arthur F Kramer, PhD University of Illinois at Chicago
  More Information

Additional Information:
No publications provided

Responsible Party: Edward McAuley, Professor, Kinesiology and Community Health, University of Illinois at Urbana-Champaign
ClinicalTrials.gov Identifier: NCT01472744     History of Changes
Other Study ID Numbers: R37 AG025667, 392
Study First Received: August 18, 2011
Last Updated: May 14, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by University of Illinois at Urbana-Champaign:
Executive function
Aging
Physical activity

ClinicalTrials.gov processed this record on August 28, 2014