Clinical trial NCT04512040: At-Home Telehealth Yoga for Treating Chronic Pain in People With Alzheimer's Disease and Their Caregiver's
Official title: Feasibility of At-Home Telehealth Yoga for Treating Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Musculoskeletal Pain
Chronic Pain
Keywords: Alzheimer Disease
yoga
telehealth
caregiver
Lead sponsor: Palo Alto Veterans Institute for Research
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2020-08-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants are assigned a treatment group for the duration of the study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)
* Exclusion Criteria for Caregiver
* Participation in another concurrent clinical trial
* Attended or practiced yoga ≥ 1 x in the past 12 months
* Attended or practiced yoga ≥ 1 x in the past 12 months

Primary outcomes:
measure: Attendance
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
measure: Treatment Satisfaction: Questionnaire
timeFrame: immediately after the final treatment session (1 day)
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System
state: California
Study officials:
affiliation: PAVIR/VA
name: Peter Bayley, PhD
role: PRINCIPAL_INVESTIGATOR
References: