At-Home Telehealth Yoga for Treating Chronic Pain in People With Alzheimer's Disease and Their Caregiver's
June 13, 2023 updated by: Peter Bayley, Palo Alto Veterans Institute for Research
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Palo Alto, California, United States, 94304
- VA Palo Alto Health Care System
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
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.
|
At-home yoga practice over 12 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Attendance
Time Frame: 12 weeks
|
% of classes attended in 12 weeks of treatment
|
12 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Treatment Satisfaction: Questionnaire
Time Frame: immediately after the final treatment session (1 day)
|
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
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Peter Bayley, PhD, PAVIR/VA
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.