At-Home Telehealth Yoga for Treating Chronic Pain in People With Alzheimer's Disease and Their Caregiver's

Not Applicable

Completed

• Conditions: Chronic Pain; Alzheimer Disease; Musculoskeletal Pain

• Registration Number: NCT04512040
• Lead Sponsor: Palo Alto Veterans Institute for Research

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.

Study Timeline

• Study First Submitted: 2020-08-06
• Study First Submitted QC: 2020-08-12
• Study First Posted: 2020-08-13
• Study Start: 2021-02-25
• Primary Completion: 2022-05-09
• Study Completion: 2022-05-09
• Results First Submitted: 2023-05-01
• Status Verified: 2023-06
• Results First Submitted QC: 2023-06-13
• Last Update Submitted: 2023-06-13
• Results First Posted: 2023-06-15
• Last Update Posted: 2023-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Attendance	12 weeks	% of classes attended in 12 weeks of treatment

Trial Locations

Locations (1)

VA Palo Alto Health Care System; 🇺🇸 Palo Alto, California, United States