Activate For Life: mHealth Intervention To Address Pain And Fatigue In Low-income Older Adults Aging In Place

NCT03853148 | Completed Results DMC

• 2 other identifiers: Pr000768355P20NR016575-05
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The Overall Aim of the present proposal is to evaluate the feasibility of an integrated mind-body intervention, Activate for Life, to improve overall physical activity and mental health and reduce pain and fatigue, resulting in increased likelihood of Aging in Place. Both subjective self-report (i.e., Patient-Reported Outcomes Measurement Information System PROMIS measures of pain, fatigue, depression and anxiety) and objective accelerometer data will be collected, along with standardized measures of balance, strength, and stability. In addition, the measures will be complemented with biomarker-based measures of stress, including cortisol based and 1,5-AG anhydroglucitol assays before, during, and after treatment that are correlated with stress, and fatigue symptoms.

Conditions

Pain, Chronic; Fatigue Syndrome, Chronic; Aging

Outcome Measures

Primary Outcomes (3)

• Older Adult Pain Intensity

  Change in mean pain T-scores as measured with the Patient-Reported Outcomes Measurement Information System PROMIS Pain Intensity short form 3a, which allows for individuals to report how much a person hurts. The lowest possible raw score is 4; the highest possible raw score is 20. Raw summed scores are converted to T-score values that are standardized such that 50 represents the average (mean) for the US general population, and a standard deviation of 10 points. A higher T-score represents more of the concept being measured, meaning the higher above 50 the more pain interferes with aspects of one's life compared to the general population. Scores \<55 within normal limits, 55-60 mild, 61-70 moderate, \>70 severe pain intensity.

  Baseline to 12 weeks

• Older Adult Fatigue

  Change in mean fatigue T-score as measured by PROMIS Fatigue short form 6a, 6 items that assess a range of self-reported symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. The lowest possible raw score is 6; the highest possible raw score is 30. Raw summed scores are converted to T-score values that are standardized such that 50 represents the average (mean) for the US general population, and a standard deviation of 10 points. A higher T-score represents more of the concept being measured, meaning the higher above 50 the worse the fatigue the individual has compared to the general population. Scores \<55 within normal limits, 55-60 mild, 61-70 moderate, \>70 severe fatigue.

  Baseline to 12 weeks

• Older Adult Pain Behavior

  Change in mean pain T-score as measured with PROMIS Pain Behavior short form 7a, which allows for self-reported external manifestations of pain: behaviors that typically indicate to others that an individual is experiencing pain. These actions or reactions can be verbal or nonverbal, and involuntary or deliberate. The lowest possible raw score is 7; the highest possible raw score is 42. Raw summed scores are converted to T-score values that are standardized such that 50 represents the average (mean) for the US general population, and a standard deviation of 10 points. A higher T-score represents more of the concept being measured, meaning the higher above 50 the worse or more pain behavior the individual has compared to the general population. Scores \<55 within normal limits, 55-60 mild, 61-70 moderate, \>70 severe pain behavior.

  Baseline to 12 weeks

Secondary Outcomes (25)

• Older Adult Functional Status

  Baseline to 12 weeks

• Older Adult Balance

  Baseline to 12 weeks

• Older Adult Sit-to-Stand Capability

  Baseline to 12 weeks

• Older Adult Walking Ability

  Baseline to 12 weeks

• Older Adult Depression

  Baseline to 12 weeks

Study Arms (4)

Otago

ACTIVE COMPARATOR

The Otago exercise program consists of the following: 1) A series of warm-up exercises, 2) Select exercises from the 17 Otago exercises which challenge the participant's strength and balance for up to 30 minutes, three times a week, 3) A walking program for up to 30 minutes, three times a week. Each Otago will be tailored for each participant's ability level.

Behavioral: Otago

Otago + Gentle yogic breathing

ACTIVE COMPARATOR

The GYYB is a one-hour program containing gentle physical Yoga postures that participants could practice sitting on a chair for 30 minutes. These exercises are designed based on improving the overall flexibility, bodily control and mindfulness in movements. Following the gentle yoga postures, the participants will perform Yogic breathing exercises for 30 minutes. These exercises are known to promote relaxation, mood, pain and anxiety scores that are highly relevant to the target population and are reported to stimulate measurable biomarker changes in the saliva. During the in-person session the Yoga instructor will explain the GYYB program to participants in the Otago+GYYB group each exercise and their perceived benefits.

Behavioral: Otago; Behavioral: Gentle yogic breathing

Otago + GYYB + Behavioral activation

ACTIVE COMPARATOR

This condition will incorporate Otago and GYYB as above and will also include behavioral activation to address motivation and affect. Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities. Each participant outlines general values and specific behaviors that 'demonstrate' each value, compiling a list of the latter. This list is then used to generate 10 to 20 highly defined values-based, reinforcing activities. Next, this list is combined with the activities outlines in Otago and GYYB and this master list is used to schedule these values-based activities for the next two days.

Behavioral: Otago; Behavioral: Gentle yogic breathing; Behavioral: Behavioral Activation

Caregiver Gentle yoga & yogic breathing

EXPERIMENTAL

The GYYB is a one-hour program containing gentle physical Yoga postures that participants could practice sitting on a chair for 30 minutes. These exercises are designed based on improving the overall flexibility, bodily control and mindfulness in movements. Following the gentle yoga postures, the participants will perform Yogic breathing exercises for 30 minutes. These exercises are known to promote relaxation, mood, pain and anxiety scores that are highly relevant to the target population and are reported to stimulate measurable biomarker changes in the saliva. During the in-person session the Yoga instructor will explain the GYYB program to participants in the GYYB group each exercise and their perceived benefits.

Behavioral: Caregiver Gentle yogic breathing

Interventions

Otago BEHAVIORAL

Exercise program for strength and balance

Otago; Otago + GYYB + Behavioral activation; Otago + Gentle yogic breathing

Gentle yogic breathing BEHAVIORAL

yogic breathing

Also known as: GYYB

Otago + GYYB + Behavioral activation; Otago + Gentle yogic breathing

Behavioral Activation BEHAVIORAL

Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities.

Otago + GYYB + Behavioral activation

Caregiver Gentle yogic breathing BEHAVIORAL

yogic breathing

Also known as: Caregiver GYYB

Caregiver Gentle yoga & yogic breathing

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Males and females older adults 60 years of age and older living in a Humanities Foundation apartment complex or in their own homes
• PROMIS pain interference score of eight or above and/or a PROMIS pain behavior score of 15 or above (for older adults)
• Able to ambulate 150 feet with or without the use of an assistive device
• Able to follow simple instructions
• Able to read, speak, and write English,
• Able to operate tablet device and wearable activity tracker,
• Not currently enrolled in an exercise program.
• Inability or unwillingness of participant to give informed consent,
• Physical, cognitive, sensory or psychiatric disability that would limit participants from engaging in self-management program as noted by a Mini-Cog score of 0-2.
• Unwillingness to wear a physical activity tracker during the course of the study.
• CG must be able to speak and read English
• CG must be 45 years of age or older
• CG must be able to provide consent for himself or herself
• CG must live with or on same property as the PWD
• CG be primarily responsible for care provision of the PWD in the home (i.e., is not paid for services; provides 4 hours or more of care/day; assists with activities of daily living-ADLs)

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

College of Nursing Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (2)

• Kelechi TJ, Layne D, Mueller M, Madisetti M, Balasubramanian S. Feasibility and Preliminary Impact of a Web-Based Mind Body Intervention for Older Dementia Caregivers. West J Nurs Res. 2024 Jun;46(6):416-427. doi: 10.1177/01939459241247926. Epub 2024 Apr 24.

  PMID: 38655852 DERIVED

• Hernandez-Tejada MA, Nagel A, Madisetti M, Balasubramanian S, Kelechi T. Feasibility trial of an integrated treatment "Activate for Life" for physical and mental well-being in older adults. Pilot Feasibility Stud. 2022 Feb 11;8(1):38. doi: 10.1186/s40814-022-01000-8.

  PMID: 35148798 DERIVED

MeSH Terms

Conditions

Chronic Pain; Fatigue Syndrome, Chronic

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes

Results Point of Contact

• Title: Teresa Kelechi, Associate Dean for Research and PhD Studies
• Organization: Medical University of South Carolina

kelechtj@musc.edu

843-792-4602

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 22, 2019
• First Posted: February 25, 2019
• Study Start: February 6, 2019
• Primary Completion: April 30, 2022
• Study Completion: May 25, 2022
• Last Updated: July 29, 2022
• Results First Posted: July 29, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)