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

Feasibility of At-Home Telehealth Yoga for Treating Chronic Pain

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").

Study Overview

• Status: Completed
• Conditions: Musculoskeletal Pain; Chronic Pain; Alzheimer Disease
• Intervention / Treatment: Behavioral: At-Home Yoga

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • VA Palo Alto Health Care System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Yoga Dyads AD patients and Caregivers; Initially Yoga will be delivered in 1-on-1 format between the yoga therapist and the AD/caregiver dyad. Five outpatient adults, with chronic musculoskeletal pain and a diagnosis of mild AD and their Caregiver, will receive at-home teleyoga classes via video conferencing. Later, yoga will be delivered in a group format. Ten outpatient adults with chronic musculoskeletal pain and a diagnosis of mild AD and their Caregiver will receive group at-home teleyoga classes via video conferencing.

Behavioral: At-Home Yoga; At-home yoga practice over 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attendance	% of classes attended in 12 weeks of treatment	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	immediately after the final treatment session (1 day)

Collaborators and Investigators

• Sponsor: Palo Alto Veterans Institute for Research
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Peter Bayley, PhD, PAVIR/VA

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2021
• Primary Completion (Actual): May 9, 2022
• Study Completion (Actual): May 9, 2022

Study Registration Dates

• First Submitted: August 6, 2020
• First Submitted That Met QC Criteria: August 12, 2020
• First Posted (Actual): August 13, 2020

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 13, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Alzheimer Disease; yoga; caregiver; telehealth
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Neurocognitive Disorders; Musculoskeletal Diseases; Muscular Diseases; Neurodegenerative Diseases; Dementia; Tauopathies; Chronic Pain; Alzheimer Disease; Musculoskeletal Pain
• Other Study ID Numbers: BAY0006AGGAD; 3R34AT010364-02S1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: de-identified electronic data sets of outcomes will be made available.
• IPD Sharing Time Frame: End of treatment
• IPD Sharing Access Criteria: upon written request to the corresponding author of the manuscripts that are generated from this project
• IPD Sharing Supporting Information Type: SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No