N/A
N=50
Activate For Life: mHealth Intervention To Address Pain And Fatigue In Low-income Older Adults Aging In Place
Pain, Chronic · Fatigue Syndrome, Chronic · Aging
Bottom Line
View on ClinicalTrials.gov: NCT03853148 ↗Enrolled (actual)
50
Serious AEs
6.0%
Results posted
Jul 2022
Primary outcome: Primary: Older Adult Pain Intensity — -3.25; -2.8; -0.5 T-score
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Otago (Behavioral); Gentle yogic breathing (Behavioral); Behavioral Activation (Behavioral); Caregiver Gentle yogic breathing (Behavioral)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Older Adult Pain Intensity |
-3.25; -2.8; -0.5 | — |
| PRIMARY Older Adult Fatigue |
0.9; -0.8; -4.0 | — |
| PRIMARY Older Adult Pain Behavior |
-0.7; 2.2; -3.7 | — |
| SECONDARY Older Adult Functional Status |
1.0; 3.1; 1.5; 1.7 | — |
| SECONDARY Older Adult Balance |
-1.8; -4.5; -4.5 | — |
| SECONDARY Older Adult Sit-to-Stand Capability |
— | — |
| SECONDARY Older Adult Walking Ability |
17.4; -6.8; 24 | — |
| SECONDARY Older Adult Depression |
-1.57; 0.37; -5.26 | — |
| SECONDARY Older Adult Self Efficacy |
-0.39; 0.06; -0.31 | — |
| SECONDARY Older Adult Daily Steps |
32201; 29577; 24699 | — |
| SECONDARY Caregiver Anxiety |
1.7 | — |
| SECONDARY Caregiver Health Status |
1.2 | — |
| SECONDARY Caregiver Functional Health |
1.7 | — |
| SECONDARY Caregiver Sleep Disturbance |
-0.6 | — |
| SECONDARY Caregiver Depression |
-0.8 | — |
| SECONDARY Caregiver Depression CES-D |
-0.3 | — |
| SECONDARY Caregiver Fatigue |
-4.7 | — |
| SECONDARY Caregiver Loneliness |
-0.9 | — |
| SECONDARY Caregiver Social Support |
1.4 | — |
| SECONDARY Caregiver Burden |
3.4 | — |
| SECONDARY Caregiver Quality of Life (QOL) |
-6.3 | — |
| SECONDARY Caregiver Relationship Quality |
0.2 | — |
| SECONDARY Person With Dementia Quality of Life |
1.9 | — |
| SECONDARY Person With Dementia Activities of Daily Living |
1.0 | — |
| SECONDARY Caregiver of Persons With Dementia Physical Activity |
213 | — |
| SECONDARY Salivary Cortisol |
-0.03; 0.6; -0.5; 2.3 | — |
| SECONDARY Salivary 1,5-Anhydroglucitol (AG) |
5.3; 5.4; 3.9; 4.8 | — |
| SECONDARY Adherence |
6; 4; 3; 7 | — |
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.
Eligibility Criteria
Inclusion and Exclusion Criteria for Older Adults (Arms 1, 2, 3):
- 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.
Exclusion Criteria
- 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.
Inclusion and Exclusion Criteria for Caregivers (Arm 4)
- 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)
Exclusion Criteria
- CG for whom yoga techniques would be detrimental due to physical limitations,
- CG who are enrolled in other Yoga-related clinical trials, or who are currently engaged in regular Yoga activity once per week or more.
Data sourced from ClinicalTrials.gov (NCT03853148). 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.