Enhancing Well-Being Through Exercise During Old Age

University of Illinois

Status: Completed

Conditions: Osteoarthritis; Depression

Treatments: Behavioral: Wait list; Behavioral: Fit & Strong!

Study type: Interventional

Funder types: Other

Identifiers

NCT04536727

2013-1027

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

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).

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:

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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28 participants in 2 patient groups, including a placebo group

Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Fit & Strong!

Wait list

Placebo Comparator group

Description:

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

Treatment:

Behavioral: Wait list