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

NCT04512040 | Completed Results DMC

• 2 other identifiers: BAY0006AGGAD3R34AT010364-02S1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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").

Conditions

Alzheimer Disease; Musculoskeletal Pain; Chronic Pain

Keywords

Alzheimer Disease; yoga; telehealth; caregiver

Outcome Measures

Primary Outcomes (1)

• Attendance

  % of classes attended in 12 weeks of treatment

  12 weeks

Other Outcomes (1)

• Treatment Satisfaction: Questionnaire

  immediately after the final treatment session (1 day)

Study Arms (1)

Yoga Dyads AD patients and Caregivers

EXPERIMENTAL

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

Interventions

At-Home Yoga BEHAVIORAL

At-home yoga practice over 12 weeks.

Yoga Dyads AD patients and Caregivers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• AD PATIENTS
• 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.

You may not qualify if:

• 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)
• 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)
• 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

Sponsors & Collaborators

• Palo Alto Veterans Institute for Research: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

VA Palo Alto Health Care System

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Musculoskeletal Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Peter Bayley, PhD
• Organization: VA Palo Alto Health Care System

peter.bayley@va.gov

650-493-5000

Study Officials

• Peter Bayley, PhD

  PAVIR/VA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants are assigned a treatment group for the duration of the study

Study Record Dates

• First Submitted: August 6, 2020
• First Posted: August 13, 2020
• Study Start: February 25, 2021
• Primary Completion: May 9, 2022
• Study Completion: May 9, 2022
• Last Updated: June 15, 2023
• Results First Posted: June 15, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: End of treatment
• Access Criteria: upon written request to the corresponding author of the manuscripts that are generated from this project

Locations

US (1)