Alzheimer DiseaseNCT04512040
At-Home Telehealth Yoga for Treating Chronic Pain in People With Alzheimer's Disease and Their Caregiver's
A study testing At-Home Yoga in people with Alzheimer Disease and Musculoskeletal Pain, run by Palo Alto Veterans Institute for Research at 1 site in United States.
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"). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alzheimer Disease, Musculoskeletal Pain, Chronic Pain
- What is being tested?
- At-Home Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2021to 9 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Palo Alto Health Care System
Palo Alto, California, 94304
About this study
Official title: 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").
Read the 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.
- Conditions
- Alzheimer Disease, Musculoskeletal Pain, Chronic Pain
- Being tested
- At-Home Yoga
- Keywords
- Alzheimer Disease, yoga, telehealth, caregiver
- Medical subject headings
- Alzheimer Disease, Musculoskeletal Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
At-Home YogaBehavioural
At-home yoga practice over 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: At-Home Yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attendance
% of classes attended in 12 weeks of treatment
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start25 Feb 2021
- Primary completion9 May 2022
- Study completion9 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants are assigned a treatment group for the duration of the study
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Palo Alto Veterans Institute for Research
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Peter Bayley, Palo Alto Veterans Institute for Research
- Investigators
- Peter Bayley, PhD, Principal investigator, PAVIR/VA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04512040
- Sponsor's protocol ID
- BAY0006AGGAD
- Other IDs
- 3R34AT010364-02S1
- Status last verified
- Jun 2023
- First submitted
- 6 Aug 2020
- Last updated
- 15 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: de-identified electronic data sets of outcomes will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of At-Home Telehealth Yoga for Treating Chronic Pain
- ClinicalTrials.gov ID
- NCT04512040
- Acronym / sponsor ID
- BAY0006AGGAD
- Conditions
- Alzheimer Disease, Musculoskeletal Pain, Chronic Pain
- Keywords
- Alzheimer Disease, yoga, telehealth, caregiver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Palo Alto Veterans Institute for ResearchUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 25 Feb 2021 (actual)
- Primary completion
- 9 May 2022 (actual)
- Study completion
- 9 May 2022 (actual)
- First posted
- 13 Aug 2020 (actual)
- Results
- Posted 15 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants are assigned a treatment group for the duration of the study
| Arm | Type | Receives |
|---|---|---|
| Yoga Dyads AD patients and Caregivers | Experimental | Behavioral: At-Home YogaInitially 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| At-Home YogaAt-home yoga practice over 12 weeks. | Behavioural | Yoga Dyads AD patients and Caregivers |
Primary outcome
Attendance
Time frame: 12 weeks
% of classes attended in 12 weeks of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. de-identified electronic data sets of outcomes will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Bayley, PhD principal investigator
PAVIR/VA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing At-Home Yoga in people with Alzheimer Disease and Musculoskeletal Pain, run by Palo Alto Veterans Institute for Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attendance (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.