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

Primary Purpose

Alzheimer Disease, Musculoskeletal Pain, Chronic Pain

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

At-Home Yoga

About this trial

This is an interventional treatment trial for Alzheimer Disease focused on measuring Alzheimer Disease, yoga, telehealth, caregiver

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

VA Palo Alto Health Care System

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Yoga Dyads AD patients and Caregivers

Arm Description

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.

Outcomes

Primary Outcome Measures

Attendance

% of classes attended in 12 weeks of treatment

Secondary Outcome Measures

Full Information

NCT ID

NCT04512040

First Posted

August 6, 2020

Last Updated

June 13, 2023

Sponsor

Palo Alto Veterans Institute for Research

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

1. Study Identification

Unique Protocol Identification Number

NCT04512040

Brief Title

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

Official Title

Feasibility of At-Home Telehealth Yoga for Treating Chronic Pain

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

February 25, 2021 (Actual)

Primary Completion Date

May 9, 2022 (Actual)

Study Completion Date

May 9, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Palo Alto Veterans Institute for Research

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer Disease, Musculoskeletal Pain, Chronic Pain

Keywords

Alzheimer Disease, yoga, telehealth, caregiver

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Participants are assigned a treatment group for the duration of the study

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Yoga Dyads AD patients and Caregivers

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

At-Home Yoga

Intervention Description

At-home yoga practice over 12 weeks.

Primary Outcome Measure Information:

Title

Attendance

Description

% of classes attended in 12 weeks of treatment

Time Frame

12 weeks

Other Pre-specified Outcome Measures:

Title

Treatment Satisfaction: Questionnaire

Description

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.

Time Frame

immediately after the final treatment session (1 day)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter Bayley, PhD

Organizational Affiliation

PAVIR/VA

Official's Role

Principal Investigator

Facility Information:

Facility Name

VA Palo Alto Health Care System

City

Palo Alto

State/Province

California

ZIP/Postal Code

94304

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

Learn more about this trial

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

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