Skip to main content
Clinical Trials/NCT04536727
NCT04536727
Completed
N/A

Enhancing Well-Being Through Exercise During Old Age

University of Illinois at Chicago1 site in 1 country28 target enrollmentFebruary 1, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Depression
Sponsor
University of Illinois at Chicago
Enrollment
28
Locations
1
Primary Endpoint
Acceptability of Fit & Strong! Intervention
Status
Completed
Last Updated
2 years ago

Overview

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.

Detailed Description

The specific aims of this pilot are to use a small randomized controlled trial (RCT) with a wait list 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.

Registry
clinicaltrials.gov
Start Date
February 1, 2019
End Date
February 28, 2020
Last Updated
2 years ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

David Xavier Marquez

Professor

University of Illinois at Chicago

Eligibility Criteria

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 Exercise Assessment and Screening for You (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 Diagnostic and Statistical Manual (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).

Outcomes

Primary Outcomes

Acceptability of Fit & Strong! Intervention

Time Frame: Baseline, 8 weeks

Positive evaluation of the intervention assessed during the debriefing session

Attendance of the Fit & Strong! Intervention Classes

Time Frame: Baseline, 8 weeks

Total number of Fit \& Strong! classes attended (0 to 24 classes).

Secondary Outcomes

  • Physical Activity Scale for the Elderly (PASE)(Baseline, 8 weeks)
  • Gait Speed(Baseline, 8 weeks)
  • Cognition - Pattern Comparison Processing Speed Test(Baseline, 8 weeks)
  • Cerebral Functional Connectivity - Default Mode Network(Baseline, 8 weeks)
  • Cognition - Auditory Verbal Learning (Rey)(Baseline, 8 weeks)
  • Cognition - Dimensional Change Card Sort (DCCS)(Baseline, 8 weeks)
  • Cognition - Flanker Inhibitory Control and Attention(Baseline, 8 weeks)
  • Cognition - Oral Symbol Digit Test(Baseline, 8 weeks)
  • Cognition - Picture Sequence Memory Test(Baseline, 8 weeks)
  • Depressive Symptoms - Emotional Well-being Scale(Baseline, 8 weeks)
  • Motor Function - Grip Strength (Non-dominant Hand)(Baseline, 8 weeks)
  • Balance Confidence Scale(Baseline, 8 weeks)
  • Montreal Cognitive Assessment (MoCA)(Baseline, 8 weeks)
  • Motor Function - Grip Strength (Dominant Hand)(Baseline, 8 weeks)
  • Motor Function - Peg Board (Dominant Hand)(Baseline, 8 weeks)
  • Perceived Stress Scale 10-item (PSS-10)(Baseline, 8 weeks)
  • Snaith-Hamilton Pleasure Scale (SHAPS)(Baseline, 8 weeks)
  • Timed Up and Go (TUG)(Baseline, 8 weeks)
  • Cerebral Functional Connectivity - Frontoparietal Network(Baseline, 8 weeks)
  • Balance - Standing Balance Test(Baseline, 8 weeks)
  • Cognition - List Sorting(Baseline, 8 weeks)
  • Apathy Evaluation Scale (AES) Self(Baseline, 8 weeks)
  • Self-Efficacy for Exercise(Baseline, 8 weeks)
  • Satisfaction With Life Scale(Baseline, 8 weeks)
  • Western Ontario and McMaster Universities Arthritis Index (WOMAC)(Baseline, 8 weeks)

Study Sites (1)

Loading locations...

Similar Trials