N/A
N=28
Enhancing Well-Being Through Exercise During Old Age
Depression · Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT04536727 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcome: Primary: Attendance of the Fit & Strong! Intervention Classes — 10 Classes attended
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Fit & Strong! (Behavioral); Wait list (Behavioral)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- University of Illinois at Chicago
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Attendance of the Fit & Strong! Intervention Classes |
10 | — |
| PRIMARY Acceptability of Fit & Strong! Intervention |
— | — |
| SECONDARY Depressive Symptoms - Emotional Well-being Scale |
1.45; 1.42 | — |
| SECONDARY Physical Activity Scale for the Elderly (PASE) |
12.11; -16.86 | — |
| SECONDARY Motor Function - Grip Strength (Dominant Hand) |
-1.65; -2.39 | — |
| SECONDARY Cerebral Functional Connectivity - Default Mode Network |
.0022; .0921 | — |
| SECONDARY Cerebral Functional Connectivity - Frontoparietal Network |
.0583; .0593 | — |
| SECONDARY Motor Function - Grip Strength (Non-dominant Hand) |
-5.33; -0.34 | — |
| SECONDARY Motor Function - Peg Board (Dominant Hand) |
-1.66; -0.42 | — |
| SECONDARY Gait Speed |
-1.32; -0.76 | — |
| SECONDARY Cognition - Auditory Verbal Learning (Rey) |
-0.5; 3.54 | — |
| SECONDARY Balance - Standing Balance Test |
-11.56; -2.5 | — |
| SECONDARY Cognition - Dimensional Change Card Sort (DCCS) |
1.36; .08 | — |
| SECONDARY Cognition - Flanker Inhibitory Control and Attention |
-0.09; -0.38 | — |
| SECONDARY Cognition - List Sorting |
-2.36; 0.31 | — |
| SECONDARY Cognition - Oral Symbol Digit Test |
-0.91; 3.58 | — |
| SECONDARY Cognition - Pattern Comparison Processing Speed Test |
4.09; 1.92 | — |
| SECONDARY Cognition - Picture Sequence Memory Test |
5.44; 5.22 | — |
| SECONDARY Apathy Evaluation Scale (AES) Self |
1.0; -.83 | — |
| SECONDARY Balance Confidence Scale |
-2.15; -6.04 | — |
| SECONDARY Perceived Stress Scale 10-item (PSS-10) |
2.45; 1.46 | — |
| SECONDARY Satisfaction With Life Scale |
-2.00; 0.23 | — |
| SECONDARY Self-Efficacy for Exercise |
0.23; 0.00 | — |
| SECONDARY Snaith-Hamilton Pleasure Scale (SHAPS) |
2.00; 0.45 | — |
| SECONDARY Timed Up and Go (TUG) |
0.43; 0.19 | — |
| SECONDARY Western Ontario and McMaster Universities Arthritis Index (WOMAC) |
8.00; 5.91 | — |
| SECONDARY Montreal Cognitive Assessment (MoCA) |
-1.91; -1.4 | — |
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.
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:
Data sourced from ClinicalTrials.gov (NCT04536727). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.