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

Chronic Pain Clinical Trial

Official title:

Feasibility of At-Home Telehealth Yoga for Treating Chronic Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04512040
• Other study ID #: BAY0006AGGAD
• Secondary ID: 3R34AT010364-02S
• Status: Completed
• Phase: N/A
• Start date: February 25, 2021
• Est. completion date: May 9, 2022

Study information

• Verified date: June 2023
• Source: Palo Alto Veterans Institute for Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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").

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 9, 2022
• Est. primary completion date: May 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Chronic Pain
• Musculoskeletal Pain

Intervention

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

Locations

Country	Name	City	State
United States	VA Palo Alto Health Care System	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Palo Alto Veterans Institute for Research	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Primary	Attendance	% of classes attended in 12 weeks of treatment	12 weeks