Enhancing Well-Being Through Exercise During Old Age

NCT04536727 | Completed Results DMC

• 1 other identifier: 2013-1027
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Osteoarthritis

Keywords

physical activity; exercise; mental health; older adults

Outcome Measures

Primary Outcomes (2)

• Attendance of the Fit & Strong! Intervention Classes

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

  Baseline, 8 weeks

• Acceptability of Fit & Strong! Intervention

  Positive evaluation of the intervention assessed during the debriefing session

  Baseline, 8 weeks

Secondary Outcomes (25)

• Depressive Symptoms - Emotional Well-being Scale

  Baseline, 8 weeks

• Physical Activity Scale for the Elderly (PASE)

  Baseline, 8 weeks

• Motor Function - Grip Strength (Dominant Hand)

  Baseline, 8 weeks

• Cerebral Functional Connectivity - Default Mode Network

  Baseline, 8 weeks

• Cerebral Functional Connectivity - Frontoparietal Network

  Baseline, 8 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

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!

Wait list

PLACEBO COMPARATOR

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

Behavioral: Wait list

Interventions

Fit & Strong! BEHAVIORAL

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

Intervention

Wait list BEHAVIORAL

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.

Wait list

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• Non-proficient in English;
• 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;
• + 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).
• 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:

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60608, United States

Location

MeSH Terms

Conditions

Depression; Osteoarthritis; Motor Activity; Psychological Well-Being

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Personal Satisfaction

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration

Results Point of Contact

• Title: Dr. David Marquez
• Organization: University of Illinois at Chicago

marquezd@uic.edu

(312) 996-1209

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants are randomized to the intervention or wait-list group.

Study Record Dates

• First Submitted: August 28, 2020
• First Posted: September 3, 2020
• Study Start: February 1, 2019
• Primary Completion: February 28, 2020
• Study Completion: February 28, 2020
• Last Updated: September 6, 2023
• Results First Posted: September 6, 2023

Record last verified: 2022-10

Locations

US (1)