Status:

COMPLETED

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

Lead Sponsor:

Palo Alto Veterans Institute for Research

Collaborating Sponsors:

National Center for Complementary and Integrative Health (NCCIH)

Conditions:

Alzheimer Disease

Musculoskeletal Pain

Eligibility:

All Genders

18+ years

Phase:

NA

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 com...

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 ...

Eligibility Criteria

Inclusion

  • 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

    Key Trial Info

    Start Date :

    February 25 2021

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    May 9 2022

    Estimated Enrollment :

    30 Patients enrolled

    Trial Details

    Trial ID

    NCT04512040

    Start Date

    February 25 2021

    End Date

    May 9 2022

    Last Update

    June 15 2023

    Active Locations (1)

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    VA Palo Alto Health Care System

    Palo Alto, California, United States, 94304