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AgingFASTNCT01472744

Fit & Active Seniors Trial

A study testing Dance Group, Strength, Stretching, Stability and Walking in people with Aging, run by University of Illinois at Urbana-Champaign at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 60 to 79 yearsHealthy volunteers can take part
Conditions the study is for
Aging
What is being tested?
Dance Group, Strength, Stretching, Stability and Walking
Could I receive a placebo?
No, everyone receives an active treatment
How many people
247 participants
Where
1 siteUnited States
Study dates
Aug 2011to Dec 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 79 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Illinois

    Urbana, Illinois, 61801

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Aging
Being tested
Dance Group, Strength, Stretching, Stability, Walking, Walking + Nutrition
Keywords
Executive function, Aging, Physical activity
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dance GroupBehavioural

    Also called Fit & Active Seniors Trial

    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.

  • Strength, Stretching, StabilityBehavioural

    Also called Fit & Active Seniors Trial

    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.

  • WalkingBehavioural

    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.

  • Walking + NutritionBehavioural

    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.

Study groups in NCT01472744
Study groupRoleWhat they receive
DanceExperimentalParticipants will be instructed in various forms of dances such as ballroom, swing, waltz, folk, and English country.
Receives: Behavioral: Dance Group
Strengthening, Stability, StretchingActive comparatorParticipants will be instructed in various forms of strength, stretching (flexibility) and stability (balance)exercises.
Receives: Behavioral: Strength, Stretching, Stability
WalkingExperimentalParticipants 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.
Receives: Behavioral: Walking
Walking + Nutritional SupplementExperimentalParticipants 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.
Receives: Behavioral: Walking; Behavioral: Walking + Nutrition

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline to month six in brain structure and function

    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.

    Measured: Baseline and six months

  2. Change from baseline to month six in cardiorespiratory fitness

    We will conduct graded maximal exercise treadmill test measuring peak oxygen consumption at baseline and six months.

    Measured: Baseline and six months

Secondary outcomes (5)

  1. Change from baseline to month six: Quality of life

    We will assess multiple indicators of Quality of Life such as: depression; physical and mental health status; satisfaction with life; etc.

    Measured: Baseline and six months

  2. Change from baseline to month six: Self-efficacy

    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.

    Measured: Baseline, three weeks and six months

  3. Program adherence over six month intervention

    We will monitor attendance during the six-month intervention(program meets three days per week).

    Measured: Six months

  4. Change from baseline to month six: Physical function

    We will conduct functional fitness testing including tests of balance, strength, mobility and flexibility at baseline and six months.

    Measured: Baseline and six months

  5. Change from baseline to month six: Psychosocial Outcomes

    We will assess changes in psychosocial function (e.g. self-esteem; social support; anxiety) by written questionnaires.

    Measured: Baseline and six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Nov 2011 (estimated)
  2. Study startAug 2011
  3. Primary completionDec 2014
  4. Study completionDec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
247 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01472744
Sponsor's protocol ID
R37AG025667
Other IDs
392
Acronym
FAST
Status last verified
Feb 2017
First submitted
18 Aug 2011
Last updated
23 Feb 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Mendez Colmenares A, Voss MW, Fanning J, Salerno EA, Gothe NP, Thomas ML, McAuley E, Kramer AF, Burzynska AZ. White matter plasticity in healthy older adults: The effects of aerobic exercise. Neuroimage. 2021 Oct 1;239:118305. doi: 10.1016/j.neuroimage.2021.118305. Epub 2021 Jun 24.

    PubMed 34174392

  • Burzynska AZ, Voss MW, Fanning J, Salerno EA, Gothe NP, McAuley E, Kramer AF. Sensor-measured sedentariness and physical activity are differentially related to fluid and crystallized abilities in aging. Psychol Aging. 2020 Dec;35(8):1154-1169. doi: 10.1037/pag0000580. Epub 2020 Sep 24.

    PubMed 32969693

  • Gothe NP, Ehlers DK, Salerno EA, Fanning J, Kramer AF, McAuley E. Physical Activity, Sleep and Quality of Life in Older Adults: Influence of Physical, Mental and Social Well-being. Behav Sleep Med. 2020 Nov-Dec;18(6):797-808. doi: 10.1080/15402002.2019.1690493. Epub 2019 Nov 12.

    PubMed 31713442

  • Baniqued PL, Gallen CL, Voss MW, Burzynska AZ, Wong CN, Cooke GE, Duffy K, Fanning J, Ehlers DK, Salerno EA, Aguinaga S, McAuley E, Kramer AF, D'Esposito M. Brain Network Modularity Predicts Exercise-Related Executive Function Gains in Older Adults. Front Aging Neurosci. 2018 Jan 4;9:426. doi: 10.3389/fnagi.2017.00426. eCollection 2017.

    PubMed 29354050

  • Awick EA, Ehlers DK, Aguinaga S, Daugherty AM, Kramer AF, McAuley E. Effects of a randomized exercise trial on physical activity, psychological distress and quality of life in older adults. Gen Hosp Psychiatry. 2017 Nov;49:44-50. doi: 10.1016/j.genhosppsych.2017.06.005. Epub 2017 Jun 15.

    PubMed 28662897

  • Ehlers DK, Daugherty AM, Burzynska AZ, Fanning J, Awick EA, Chaddock-Heyman L, Kramer AF, McAuley E. Regional Brain Volumes Moderate, but Do Not Mediate, the Effects of Group-Based Exercise Training on Reductions in Loneliness in Older Adults. Front Aging Neurosci. 2017 Apr 25;9:110. doi: 10.3389/fnagi.2017.00110. eCollection 2017.

    PubMed 28487648

  • Burzynska AZ, Jiao Y, Knecht AM, Fanning J, Awick EA, Chen T, Gothe N, Voss MW, McAuley E, Kramer AF. White Matter Integrity Declined Over 6-Months, but Dance Intervention Improved Integrity of the Fornix of Older Adults. Front Aging Neurosci. 2017 Mar 16;9:59. doi: 10.3389/fnagi.2017.00059. eCollection 2017.

    PubMed 28360853

  • Ehlers DK, Banducci SE, Daugherty AM, Fanning J, Awick EA, Porter GC, Burzynska A, Shen S, Kramer AF, McAuley E. Effects of Gait Self-Efficacy and Lower-Extremity Physical Function on Dual-Task Performance in Older Adults. Biomed Res Int. 2017;2017:8570960. doi: 10.1155/2017/8570960. Epub 2017 Feb 1.

    PubMed 28255557

  • Ehlers DK, Fanning J, Awick EA, Kramer AF, McAuley E. Contamination by an Active Control Condition in a Randomized Exercise Trial. PLoS One. 2016 Oct 10;11(10):e0164246. doi: 10.1371/journal.pone.0164246. eCollection 2016.

    PubMed 27723781

Questions about this trial

What is this clinical trial studying?

A study testing Dance Group, Strength, Stretching, Stability and Walking in people with Aging, run by University of Illinois at Urbana-Champaign at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline to month six in brain structure and function (time frame: Baseline and six months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01472744, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.

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