Alzheimer Disease, Chronic Pain, Musculoskeletal Pain
Conditions
Keywords
Alzheimer Disease, yoga, telehealth, caregiver
Brief summary
This feasibility study will evaluate yoga as a treatment for chronic pain in people living with Alzheimer's disease, and their Caregivers. The experimental treatment is yoga delivered via a tablet computer to participants at home (teleyoga).
Detailed description
The investigators will demonstrate the feasibility of conducting a trial involving teleyoga for people with Alzheimer's disease and their Caregivers. Participants with Alzheimer's disease and chronic pain (n=15) and their Caregivers (n=15) will all participate in teleyoga classes. Yoga classes will be given weekly for 12 weeks. At the end of treatment, participants will provide feedback by completing a satisfaction questionnaire.
Interventions
BEHAVIORALAt-Home Yoga
At-home yoga practice over 12 weeks.
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Palo Alto Veterans Institute for Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants are assigned a treatment group for the duration of the study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
AD PATIENTS Inclusion Criteria for AD patients (As determined by): * Diagnosis of probable Alzheimer's disease- Baseline * Mini-Mental State Examination (MMSE) score 18-25 (Mild AD)(screening interview) * ≥ 18 years old * Has a primary care provider who can provide medical clearance for participation in the study * Diagnosis of chronic musculoskeletal pain \> 6 months * Minimum pain intensity at screening visit: pain rated ≥4 on a 0-10 Numeric Rating Scale (NRS) * Not begun new pain treatments or medications in the past month * If on a psychotropic medication regimen: stable regimen for at least 4 weeks prior to entry to the study; willingness to remain on a stable regimen during the 12-week acute treatment phase * English literacy * Wireless internet connection at home (Screening interview) * Has a caregiver who is willing to accompany AD patient for treatment, and who can receive yoga treatment at the same time as AD patient.
Exclusion criteria
for AD patients (As determined by): * Participation in another concurrent clinical trial * Back surgery within the last 12 months * Back pain potentially attributed to a specific underlying cause, disease, or condition (VA EMR; screening interview) * Baseline pain \<4 or ≥9 on a 0-10 Numeric Rating Scale (NRS) Inclusion Criteria for CAREGIVERS of AD patients (As determined by): * Are caring for a patient diagnosed with AD who will practice yoga together with them * Has a primary care provider who can provide medical clearance for participation in the study (Yoga Medical Clearance Form) *
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Attendance | 12 weeks | % of classes attended in 12 weeks of treatment |
Other
| Measure | Time frame | Description |
|---|---|---|
| Treatment Satisfaction: Questionnaire | immediately after the final treatment session (1 day) | Satisfaction of treatment was measured using the Multi-Dimensional Treatment Satisfaction Measure (MDTSM), which is composed of 33 questions that assess treatment process and outcome attributes. Each of the 33 questions is scored on a zero to 4 Likert rating scale with a score of zero indicating not at all satisfied and a score of 4 indicating very satisfied. For each participant the mean score from all 33 ratings is calculated, which produces a score ranging from zero (not at all satisfied) to 4 (very satisfied). For the assessment of feasibility, we set the group mean target score on the MDTSM to ≥2, representing neutral or positive satisfaction. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AD Patients Yoga will be delivered in 1-on-1 format between the yoga therapist and the AD/caregiver dyad.
Participants will receive at-home teleyoga classes via video conferencing. | 15 |
| Caregivers Yoga will be delivered in 1-on-1 format between the yoga therapist and the AD/caregiver dyad.
Participants will receive at-home teleyoga classes via video conferencing. | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | AD Patients | Total | Caregivers |
|---|---|---|---|
| Age, Continuous | 73.33 Years STANDARD_DEVIATION 9.79 | 68.60 Years STANDARD_DEVIATION 9.55 | 63.86 Years STANDARD_DEVIATION 9.31 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) White | 13 Participants | 24 Participants | 11 Participants |
| Region of Enrollment United States | 15 participants | 30 participants | 15 participants |
| Sex: Female, Male Female | 10 Participants | 20 Participants | 10 Participants |
| Sex: Female, Male Male | 3 Participants | 7 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
Attendance
% of classes attended in 12 weeks of treatment
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AD Patients | Attendance | 85.12 percentage of classes attended | Standard Deviation 15.75 |
| Caregivers | Attendance | 86.31 percentage of classes attended | Standard Deviation 15.19 |
Other Pre-specified
Treatment Satisfaction: Questionnaire
Satisfaction of treatment was measured using the Multi-Dimensional Treatment Satisfaction Measure (MDTSM), which is composed of 33 questions that assess treatment process and outcome attributes. Each of the 33 questions is scored on a zero to 4 Likert rating scale with a score of zero indicating not at all satisfied and a score of 4 indicating very satisfied. For each participant the mean score from all 33 ratings is calculated, which produces a score ranging from zero (not at all satisfied) to 4 (very satisfied). For the assessment of feasibility, we set the group mean target score on the MDTSM to ≥2, representing neutral or positive satisfaction.
Time frame: immediately after the final treatment session (1 day)
Population: 1 dyad dropped out during intervention, 1 dyad lost to follow up after intervention (total of 13 dyads completed outcome measures)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AD Patients | Treatment Satisfaction: Questionnaire | 3.01 score on a scale | Standard Deviation 0.69 |
| Caregivers | Treatment Satisfaction: Questionnaire | 3.30 score on a scale | Standard Deviation 0.63 |