NCT04536727

Enhancing Well-Being Through Exercise During Old Age

Completed NA Results posted Last updated 6 September 2023

What this trial tests

NA trial testing Fit & Strong! in Depression in 28 participants. Completed in 28 February 2020.

Timeline

1 February 2019

Primary endpoint
28 February 2020

28 February 2020

Quick facts

Lead sponsor	University of Illinois at Chicago
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	28
Start date	1 February 2019
Primary completion	28 February 2020
Estimated completion	28 February 2020
Sites	1 location across United States

Drugs / interventions tested

• Fit & Strong!
• Wait list

Conditions studied

• Depression — all drugs for Depression →
• Osteoarthritis — all drugs for Osteoarthritis →

Sponsor

University of Illinois at Chicago

Who can join

60 and older, any sex, with Depression or Osteoarthritis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Attendance of the Fit & Strong! Intervention Classes Primary · Baseline, 8 weeks

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

Group	Value	95% CI
Intervention	10	± 6.94

Depressive Symptoms - Emotional Well-being Scale Secondary · Baseline, 8 weeks

Assessed by self-administered questionnaire, respondents indicated how much of the time during the past 30 days- "all,""most,""some,""a little,"or "none of the time"-they felt six symptoms of positive affect. The positive affect symptoms are (1) cheerful, (2) in good spirits, (3) extremely happy,(4) calm an peaceful, (5) satisfied, and (6) full of life. Scores ranges from 6-36, with lower a score indicating greater reported emotional well-being. Change from baseline to post-test follow-up at 8-weeks is reported.

Group	Value	95% CI
Intervention	1.45	± 4.57
Wait List	1.42	± 3.58

Physical Activity Scale for the Elderly (PASE) Secondary · Baseline, 8 weeks

The PASE score combines information on leisure, household and occupational activity. The PASE assesses the types of activities typically chosen by older adults (walking, recreational activities, exercise, housework, yard work, and caring for others. It uses frequency, duration, and intensity level of activity over the previous week to assign a score, ranging from 0 to 793, with higher scores indicating greater physical activity. Change from baseline to post-test follow-up at 8-weeks is reported.

Group	Value	95% CI
Intervention	12.11	± 97.92
Wait List	-16.86	± 46.71

Motor Function - Grip Strength (Dominant Hand) Secondary · Baseline, 8 weeks

Participants are seated in a chair with their feet touching the ground. With the elbow bent to 90 degrees and the arm near the trunk, wrist at neutral, participants squeeze the dynamometer as hard as they can for a count of three. The dynamometer provides a digital reading of force in pounds. Greater force (in pounds) represents greater strength. Change from baseline to post-test follow-up at 8-weeks is reported.

Group	Value	95% CI
Intervention	-1.65	± 9.51
Wait List	-2.39	± 14.32

Cerebral Functional Connectivity - Default Mode Network Secondary · Baseline, 8 weeks

Functional connectivity is defined as a correlation of the blood oxygenation level dependent (BOLD) signal from each brain network defined by pre-specified regions of interest. Whole-brain images were acquired on a General Electric Magnetic Resonance (GE MR) 750 Discovery 3-T scanner using an 8-channel head coil. Functional connectomes were generated using the resting state functional magnetic resonance imaging (fMRI) toolbox. An increase shows improvement. Change from baseline to post-test follow-up at 8-weeks is reported.

Group	Value	95% CI
Intervention	.0022	± .2704
Wait List	.0921	± .2046

Cerebral Functional Connectivity - Frontoparietal Network Secondary · Baseline, 8 weeks

Functional connectivity is defined as a correlation of the blood oxygenation level dependent (BOLD) signal from each brain network defined by prespecified regions of interest. Whole-brain images were acquired on a GE MR 750 Discovery 3-T scanner using an 8-channel head coil. Functional connectomes were generated using the resting state functional magnetic resonance imaging (fMRI) toolbox. An increase shows improvement. Change from baseline to post-test follow-up at 8-weeks is reported.

Group	Value	95% CI
Intervention	.0583	± .2128
Wait List	.0593	± .3232

Motor Function - Grip Strength (Non-dominant Hand) Secondary · Baseline, 8 weeks

Participants are seated in a chair with their feet touching the ground. With the elbow bent to 90 degrees and the arm near the trunk, wrist at neutral, participants squeeze the dynamometer as hard as they can for a count of three. The dynamometer provides a digital reading of force in pounds. Greater force (in pounds) represents greater strength. Change from baseline to post-test follow-up at 8-weeks is reported.

Group	Value	95% CI
Intervention	-5.33	± 5.00
Wait List	-0.34	± 9.51

Motor Function - Peg Board (Dominant Hand) Secondary · Baseline, 8 weeks

This simple test of manual dexterity records the time required for the participant to accurately place and remove nine plastic pegs into a plastic pegboard. The 9-Hole Pegboard Dexterity Test provides a score for each hand, with the primary NIH Toolbox score being the number of seconds it takes the participant to complete the task using his/her dominant hand. The raw score is commonly used for interpretation, with faster completion times (less time to complete) representing better manual dexterity. Change from baseline to post-test follow-up at 8-weeks is reported.

Group	Value	95% CI
Intervention	-1.66	± 8.85
Wait List	-0.42	± 5.56

Gait Speed Secondary · Baseline, 8 weeks

Four meter walk test: Participants walk four meters at their usual pace. Participants complete one practice and then two timed trials. Score is the number of seconds it takes to walk four meters, using the better of two trials. A smaller score is better, reflecting faster walking speed. Change from baseline to post-test follow-up at 8-weeks is reported.

Group	Value	95% CI
Intervention	-1.32	± 2.75
Wait List	-0.76	± 3.96

Cognition - Auditory Verbal Learning (Rey) Secondary · Baseline, 8 weeks

The Rey is a word-list learning task in which 15 unrelated words are presented orally (via audio recording) over three consecutive learning trials1. After each presentation, the participant is asked to recall as many of the words as he/she can. The Rey is scored by taking the sum of the number of words recalled across all trials (possible range is 0-45 words). The raw score is most commonly used for interpretation of the Rey test, with higher scores representing better episodic memory. Change from baseline to post-test follow-up at 8-weeks is reported.

Group	Value	95% CI
Intervention	-0.5	± 2.99
Wait List	3.54	± 4.88

Balance - Standing Balance Test Secondary · Baseline, 8 weeks

The Standing Balance Test is a measure developed to assess static standing balance. It involves the participant assuming and maintaining up to five poses for 50 seconds each. The sequence of poses is: eyes open on a solid surface, eyes closed on a solid surface, eyes open on a foam surface, eyes closed on a foam surface, eyes open in tandem stance on a solid surface. Postural sway is recorded for each pose using an iPod Touch that the participant wears at waist level. The participant's anterior-posterior postural sway information is fed wirelessly to the iPad. A Fully Corrected T-Score is util

Group	Value	95% CI
Intervention	-11.56	± 10.51
Wait List	-2.5	± 18.58

Cognition - Dimensional Change Card Sort (DCCS) Secondary · Baseline, 8 weeks

DCCS is a measure of cognitive flexibility. Two target pictures are presented that vary along two dimensions (e.g., shape and color). Participants are asked to match a series of bivalent test pictures (e.g., yellow balls and blue trucks) to the target pictures, first according to one dimension (e.g., color) and then, after a number of trials, according to the other dimension (e.g., shape). Scoring is based on a combination of accuracy and reaction time. Scores range from 0 - 45. Higher scores indicate higher levels of cognitive flexibility. Change from baseline to post-test follow-up at 8-week

Group	Value	95% CI
Intervention	1.36	± 4.41
Wait List	.08	± 3.43

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.