Clinical trial NCT04536727: Enhancing Well-Being Through Exercise During Old Age
Official title: Enhancing Well-Being Through Exercise During Old Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Osteoarthritis
Keywords: physical activity
exercise
mental health
older adults
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2020-09-03
Enrollment: 28
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Participants are randomized to the intervention or wait-list group.
Primary purpose: TREATMENT

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.

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).

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:

Primary outcomes:
measure: Attendance of the Fit & Strong! Intervention Classes
timeFrame: Baseline, 8 weeks
measure: Acceptability of Fit & Strong! Intervention
timeFrame: Baseline, 8 weeks
Secondary outcomes:
measure: Depressive Symptoms - Emotional Well-being Scale
timeFrame: Baseline, 8 weeks
measure: Physical Activity Scale for the Elderly (PASE)
timeFrame: Baseline, 8 weeks
measure: Motor Function - Grip Strength (Dominant Hand)
timeFrame: Baseline, 8 weeks
measure: Cerebral Functional Connectivity - Default Mode Network
timeFrame: Baseline, 8 weeks
measure: Cerebral Functional Connectivity - Frontoparietal Network
timeFrame: Baseline, 8 weeks
measure: Motor Function - Grip Strength (Non-dominant Hand)
timeFrame: Baseline, 8 weeks
measure: Motor Function - Peg Board (Dominant Hand)
timeFrame: Baseline, 8 weeks
measure: Gait Speed
timeFrame: Baseline, 8 weeks
measure: Cognition - Auditory Verbal Learning (Rey)
timeFrame: Baseline, 8 weeks
measure: Balance - Standing Balance Test
timeFrame: Baseline, 8 weeks
measure: Cognition - Dimensional Change Card Sort (DCCS)
timeFrame: Baseline, 8 weeks
measure: Cognition - Flanker Inhibitory Control and Attention
timeFrame: Baseline, 8 weeks
measure: Cognition - List Sorting
timeFrame: Baseline, 8 weeks
measure: Cognition - Oral Symbol Digit Test
timeFrame: Baseline, 8 weeks
measure: Cognition - Pattern Comparison Processing Speed Test
timeFrame: Baseline, 8 weeks
measure: Cognition - Picture Sequence Memory Test
timeFrame: Baseline, 8 weeks
measure: Apathy Evaluation Scale (AES) Self
timeFrame: Baseline, 8 weeks
measure: Balance Confidence Scale
timeFrame: Baseline, 8 weeks
measure: Perceived Stress Scale 10-item (PSS-10)
timeFrame: Baseline, 8 weeks
measure: Satisfaction With Life Scale
timeFrame: Baseline, 8 weeks
measure: Self-Efficacy for Exercise
timeFrame: Baseline, 8 weeks
measure: Snaith-Hamilton Pleasure Scale (SHAPS)
timeFrame: Baseline, 8 weeks
measure: Timed Up and Go (TUG)
timeFrame: Baseline, 8 weeks
measure: Western Ontario and McMaster Universities Arthritis Index (WOMAC)
timeFrame: Baseline, 8 weeks
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: Baseline, 8 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
References: