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Completed

NCT Number: NCT04512040

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

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").

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Palo Alto Health Care System

Palo Alto, California, 94304, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

At-Home Yoga

Behavioral

At-home yoga practice over 12 weeks.

Primary outcomes

  1. Attendance

    Time frame: 12 weeks

    % of classes attended in 12 weeks of treatment

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Palo Alto Veterans Institute for Research

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

Feasibility of At-Home Telehealth Yoga for Treating Chronic Pain

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 13, 2020
Registry last updated
Jun 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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