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| ID | Type | Description | Link |
|---|---|---|---|
| 3R34AT010364-02S1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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").
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| At-Home Yoga | Behavioral | At-home yoga practice over 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Attendance | % of classes attended in 12 weeks of treatment | 12 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
AD PATIENTS
Inclusion Criteria for AD patients (As determined by):
Exclusion Criteria for AD patients (As determined by):
Inclusion Criteria for CAREGIVERS of AD patients (As determined by):
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| Name | Affiliation | Role |
|---|---|---|
| Peter Bayley, PhD | PAVIR/VA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Palo Alto Health Care System | Palo Alto | California | 94304 | United States |
de-identified electronic data sets of outcomes will be made available.
End of treatment
upon written request to the corresponding author of the manuscripts that are generated from this project
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| ID | Title | Description |
|---|---|---|
| FG000 | AD Patients | Yoga will be delivered in either a 1-on-1 format or a group format between the yoga therapist and the AD/caregiver dyad. Participants will receive at-home teleyoga classes via video conferencing. |
| FG001 | Caregivers | Yoga will be delivered in either a 1-on-1 format or a group format between the yoga therapist and the AD/caregiver dyad. Participants will receive at-home teleyoga classes via video conferencing. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AD Patients | Yoga will be delivered in 1-on-1 format between the yoga therapist and the AD/caregiver dyad. Participants will receive at-home teleyoga classes via video conferencing. |
| BG001 | Caregivers |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 1 caregiver did not provide their age at baseline |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Attendance | % of classes attended in 12 weeks of treatment | Posted | Mean | Standard Deviation | percentage of classes attended | 12 weeks |
|
baseline to end of treatment (12 weeks)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AD Patients | Yoga will be delivered in either a 1-on-1 format or a group format between the yoga therapist and the AD/caregiver dyad. Participants will receive at-home teleyoga classes via video conferencing. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter Bayley, PhD | VA Palo Alto Health Care System | 650-493-5000 | 68653 | peter.bayley@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Feb 2, 2023 | Apr 11, 2023 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D059352 | Musculoskeletal Pain |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Participants are assigned a treatment group for the duration of the study
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| immediately after the final treatment session (1 day) |
Yoga will be delivered in 1-on-1 format between the yoga therapist and the AD/caregiver dyad.
Participants will receive at-home teleyoga classes via video conferencing.
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Number of analyzed in rows differ from overall number due to no responses by some participants. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Other Pre-specified | 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. | 1 dyad dropped out during intervention, 1 dyad lost to follow up after intervention (total of 13 dyads completed outcome measures) | Posted | Mean | Standard Deviation | score on a scale | immediately after the final treatment session (1 day) |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Caregivers | Yoga will be delivered in either a 1-on-1 format or a group format between the yoga therapist and the AD/caregiver dyad. Participants will receive at-home teleyoga classes via video conferencing. | 0 | 15 | 0 | 15 | 0 | 15 |
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|