Enhancing Well-Being Through Exercise During Old Age

Sponsor
University of Illinois at Chicago (Other)
Overall Status
Completed
CT.gov ID
NCT04536727
Collaborator
(none)
28
1
2
12.9
2.2

Study Details

Study Description

Brief Summary

Determine the feasibility of adapting Fit & Strong!, an evidence-based group physical activity and health education program, to include affect and mood-related content and of employing this intervention among older adults with a range of depressive symptoms.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Fit & Strong!
  • Behavioral: Wait list
N/A

Detailed Description

The specific aims of this pilot are to use a small RCT with a waitlist control design to: 1) Determine the feasibility of adapting Fit & Strong! to include affect and mood-related content and of employing this intervention among older adults with a range of depressive symptoms. 2) Begin to determine whether Fit & Strong! is efficacious as an approach for improving positive affect, reducing negative affect, decreasing symptoms of depression, and improving cognition among older adults. 3) Explore the relationship between negative/positive affect and symptoms of depression and maintenance of physical activity between baseline and 2 months, in order to determine whether improved positive affect and reduced negative affect and depression and improved cognition are associated with an increase in physical activity.

Study Design

Study Type:
Interventional
Actual Enrollment :
28 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
Participants are randomized to the intervention or wait-list group.Participants are randomized to the intervention or wait-list group.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Enhancing Well-Being Through Exercise During Old Age
Actual Study Start Date :
Feb 1, 2019
Actual Primary Completion Date :
Feb 28, 2020
Actual Study Completion Date :
Feb 28, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

The 8-week intervention will consist of the Fit & Strong! program adapted to address the impact of exercise on enhancing positive affect and reducing negative affect and depressive symptoms. Exercise classes will meet three times per week for 90 minutes per session for eight weeks. Each class is divided into 60 minutes of strength training, flexibility, and cardiovascular exercise and 30 minutes of group education/discussion, which has been adapted to include affect-oriented content.

Behavioral: Fit & Strong!
The 8-week intervention will consist of the Fit & Strong! program adapted to address the impact of exercise on enhancing positive affect and reducing negative affect and depressive symptoms. Exercise classes will meet three times per week for 90 minutes per session for eight weeks. Each class is divided into 60 minutes of strength training, flexibility, and cardiovascular exercise and 30 minutes of group education/discussion, which has been adapted to include affect-oriented content

Placebo Comparator: Wait list

Participants randomized to the wait list group, receive the 8-week Fit & Strong! intervention after the intervention group has completed it.

Behavioral: Wait list
Participants randomized to the wait list group receive the 8-week Fit & Strong! intervention after the intervention group has competed it and after the wait list group has provided their post-outcomes.

Outcome Measures

Primary Outcome Measures

  1. Adherence to the Fit & Strong! intervention [8 weeks]

    Attending two-thirds of the 24 sessions over 8 weeks

  2. Acceptability of Fit & Strong! intervention [8 weeks]

    Positive evaluation of the intervention assessed during the debriefing session

Secondary Outcome Measures

  1. Depressive symptoms [8 weeks]

    Measures of positive and negative affect

  2. Physical activity [8 weeks]

    Self reported increase in level of physical activity

  3. Cognition [8 weeks]

    NIH Toolbox cognitive measures

  4. Motor function [8 weeks]

    NIH toolbox motor measures

  5. Brain structure [8 weeks]

    MRI scans

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • ages 60+;

  • Sufficient visual and hearing capacity to follow instructions;

  • a score of at least 1 on the Patient Health Questionnaire-8 (Kroenke et al., 2001);

  • Six Item Screener (Callahan, 2002) score > 4;

  • pass screening with the EASY scale [Cardinal et al., 1996] or have doctor's clearance to participate;

  • no recent (<6 months) joint replacements;

  • physically inactive (<150 minutes of exercise per week);

  • able to walk at least 20 feet (with or without the aid of a cane or walker);

  • speak English proficiently.

Exclusion Criteria:
  • Non-proficient in English;

  • 0 on the Patient Health Questionnaire-8 (Kroenke et al., 2001);

  • Six Item Screener < 5 (Callahan, 2005);

  • fail screening with the EASY scale and does not have doctor's clearance to participate;

  • joint replacement in last 6 months;

  • 150+ minutes of exercise per week;

  • unable to walk at least 20 feet;

  • severe medical illness (i.e., metastatic cancer, brain tumors, unstable cardiac, hepatic, or renal disease, myocardial infarction or stroke) within the 3 months preceding the study;

  • Other brain/neurological disorders (i.e., dementia or delirium according to DSM-IV criteria, history of severe head trauma, Parkinson's disease or Parkinson's plus syndromes, multiple sclerosis, epilepsy);

  • Conditions often associated with depression (i.e., endocrinopathies other than diabetes, lymphoma, and pancreatic cancer).

Potential participants for the optional MRI component will be excluded for the following:
  • cardiac pacemaker or defibrillator

  • metal parts in head, spinal cord, eyes, or chest

  • past operation or radiation therapy with skull or brain: e) aneurysm clips

  • dentures that have been surgically implanted with magnets, braces:

  • claustrophobia:

  • heart valve replacement:

  • history of work with metal resulting in an injury:

  • eye injury with metal:

  • history of strokes/seizures:

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Illinois at Chicago Chicago Illinois United States 60608

Sponsors and Collaborators

  • University of Illinois at Chicago

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
David Xavier Marquez, Professor, University of Illinois at Chicago
ClinicalTrials.gov Identifier:
NCT04536727
Other Study ID Numbers:
  • 2013-1027
First Posted:
Sep 3, 2020
Last Update Posted:
Sep 3, 2020
Last Verified:
Sep 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by David Xavier Marquez, Professor, University of Illinois at Chicago
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 3, 2020