Fit & Active Seniors Trial

NCT01472744 | Completed DMC

• 2 other identifiers: R37AG025667392
• Study Type: interventional
• Target: 247
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Aging

Keywords

Executive function; Aging; Physical activity

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline and six months

• 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.

  Baseline and six months

Secondary Outcomes (5)

• Change from baseline to month six: Quality of life

  Baseline and six months

• Change from baseline to month six: Self-efficacy

  Baseline, three weeks and six months

• Program adherence over six month intervention

  Six months

• Change from baseline to month six: Physical function

  Baseline and six months

• Change from baseline to month six: Psychosocial Outcomes

  Baseline and six months

Study Arms (4)

Dance

EXPERIMENTAL

Participants will be instructed in various forms of dances such as ballroom, swing, waltz, folk, and English country.

Behavioral: Dance Group

Strengthening, Stability, Stretching

ACTIVE COMPARATOR

Participants will be instructed in various forms of strength, stretching (flexibility) and stability (balance)exercises.

Behavioral: Strength, Stretching, Stability

Walking

EXPERIMENTAL

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

Walking + Nutritional Supplement

EXPERIMENTAL

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; Behavioral: Walking + Nutrition

Interventions

Dance Group BEHAVIORAL

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.

Also known as: Fit & Active Seniors Trial

Dance

Strength, Stretching, Stability BEHAVIORAL

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.

Also known as: Fit & Active Seniors Trial

Strengthening, Stability, Stretching

Walking BEHAVIORAL

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; Walking + Nutritional Supplement

Walking + Nutrition BEHAVIORAL

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.

Walking + Nutritional Supplement

Eligibility Criteria

• Age: 60 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Urbana-Champaign: lead

Study Sites (1)

University of Illinois

Urbana, Illinois, 61801, United States

Location

Related Publications (9)

• 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.

  PMID: 34174392 DERIVED

• 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.

  PMID: 32969693 DERIVED

• 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.

  PMID: 31713442 DERIVED

• 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.

  PMID: 29354050 DERIVED

• 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.

  PMID: 28662897 DERIVED

• 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.

  PMID: 28487648 DERIVED

• 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.

  PMID: 28360853 DERIVED

• 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.

  PMID: 28255557 DERIVED

• 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.

  PMID: 27723781 DERIVED

Related Links

• Exercise Psychology Laboratory

MeSH Terms

Conditions

Motor Activity

Interventions

Walking; Nutritional Status

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics

Study Officials

• Arthur F Kramer, PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Kinesiology and Community Health

Study Record Dates

• First Submitted: August 18, 2011
• First Posted: November 16, 2011
• Study Start: August 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 23, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)