Evaluation of the Wits Workout Wellness Program for Older Adults

Cognitive Decline Clinical Trial

Official title:

Evaluation of the Wits Workout Wellness Program for Older Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04928885
• Other study ID #: 2021-0305
• Secondary ID: P30AG022849
• Status: Completed
• Phase: N/A
• Start date: July 7, 2021
• Est. completion date: August 30, 2022

Study information

• Verified date: March 2024
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

About 11% of the U.S. older adult population is at risk for or suffers from subjective cognitive decline. While some factors such as genetics and habitual physiological changes that affect brain health cannot be changed, research has shown that lifestyle changes such as participation in regular physical activity, staying socially engaged, and managing stress and diet can help to delay or reduce cognitive decline. Yet few brain health promotion programs exist and those that do fail to focus on global health and wellness as a strategy to improve brain health. Wits Workout is a holistic, 12-session, 60-minute per session, multi-modal workshop series that offers adults ages 50 and older facilitated, interactive dialogue and activities about behaviors that promote brain health. Each week includes a different themed module which has four activities and a training component.

Description:

While research has shown that lifestyle changes such as participation in regular physical activity, staying socially engaged, and managing stress can help to delay or reduce cognitive decline, few cognitive brain health programs exist. Those that do are targeted to a specific audience (i.e., Alzheimer's and related dementias) and primarily focus on one health domain (i.e. physical activity, diet) without the additional focus on multi-dimensions of health, which can also include intellectual engagement, social isolation, stress, sleep, and self-efficacy. Thus, there is a need for a more holistic cognitive health program aimed toward the general older adult population and particularly those that are underserved due to geographic location. Wits Workout, is a multi-modal 12-session (60 min/week) workshop series designed to enhance brain health among people ages 50 and older. Wits Workout addresses multiple factors that affect cognitive health such as physical activity, diet, intellectual engagement, social isolation, stress, sleep, and self-efficacy. The holistic workshop series is designed to be lay-leader led, interactive, and experiential. Preliminary evaluations demonstrate that this educational series serves a need in reducing isolation, increasing physical activity, promoting intellectual engagement, and enhancing overall brain health in older participants, all of which complement current aging brain health research. The researchers propose to conduct a two-arm randomized controlled trial with a treatment (workshop) group (n=120) and wait-list control group (n=120) who will receive the program after the 6-month study period is completed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 285
• Est. completion date: August 30, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• 50 years or older
• English-speaking and/or able to understand English
• Have no diagnosis of Alzheimer's or related dementia
• Score 28 or higher on the TICS cognitive screening
• Able to participate in the 12 week program
• Have not previously participated in a Wits Workout program

Exclusion Criteria:

• Under age 50,
• Unable to speak or understand English,
• Have a diagnosis of Alzheimer's or related dementia,
• Score lower than 28 on TICS
• Plan to miss more than two weeks of the program (i.e. traveling during that time period)
• Have previously participated in a Wits Workout program.

Related Conditions & MeSH terms

• Cognitive Decline
• Cognitive Dysfunction
• Health Behaviors
• Self Efficacy
• Social Isolation

Intervention

Behavioral:
• Wits Workout Program
12 week, one hour per week multi-modal, interactive training.

Other:
• Control Group that receives intervention after the study
The control group will not receive the intervention during study period but will take baseline, 3 mos and 6 mos surveys. They will complete the workshop after the study period is over.

Locations

Country	Name	City	State
United States	University of Illinois at Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Chicago	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Cognitive Function	The PROMIS Cognitive Function measure used to measure cognitive functioning. Raw score is converted into the T-score, with 50 being the mean score. 10 T-score is one standard deviation. Therefore, score above 50 means that a person is better than the average population in mental ability, and lower score meaning worse or disability. The score changing over time can indicate decline in cognitive function (lower score) or improved cognitive function (higher score) or no decline or improvement (same score).	Baseline prior to the workshop, at 3 months after baseline and at 6 months after baseline
Primary	Change in Cognitive Status	Telephone Interview for Cognitive Status (TICS). Used to measure cognitive status. For TICS - the minimum = 0 maximum = 50. Higher scores mean better cognition.	Baseline prior to the workshop, at 3 months after baseline and at 6 months after baseline
Secondary	Change in Social Satisfaction	Social Provisions Scale. Range of total score should be 24-96 with higher scores being a better outcome.	Baseline prior to the workshop, at 3 months after baseline and at 6 months after baseline
Secondary	Change in Physical Activity Levels	Physical Activity Scale for the Elderly (PASE). Scores range from 0 to 793, with higher scores indicating greater physical activity	Baseline prior to the workshop, at 3 months after baseline and at 6 months after baseline
Secondary	Stress	Perceived Stress Scale (PSS). Total scores range from 0 to 40. Higher scores indicate higher stress.	Baseline prior to the workshop, at 3 months after baseline and at 6 months after baseline
Secondary	Change in Sleep	Pittsburgh Sleep Quality Index (PSQI). The PSQI has 7 sections which are scored. The seven component scores are then summed to yield a global PSQI score, which has a range of 0-21; higher scores indicate worse sleep quality.	Baseline prior to the workshop, at 3 months after baseline and at 6 months after baseline
Secondary	Self-efficacy	PROMIS general self efficacy short-form. Survey scores are changed into a T score, with a mean of 50 and a standard deviation of 10. The higher the score the greater the self-efficacy.	Baseline prior to the workshop, at 3 months after baseline and at 6 months after baseline