- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04316455
Self-managed Integrative Yoga Therapy for Older Adults Living With Chronic Pain
March 18, 2020 updated by: Aarogyam UK
Impact of Self-managed Integrative Yoga Therapy for Older Adults Living With Chronic Pain
Chronic pain self-management skills can help patients improve daily functioning and quality of life.
The goal of this study is to evaluate chronic pain self-managed Integrative Yoga Therapy intervention delivered in a sample of 25 older adults recruited from community site in Leicester.
Study Overview
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Leicestershire
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Leicester, Leicestershire, United Kingdom
- Karyalaya
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Willing to provide informed consent
- Age >= 60 years
- Ambulatory
- Community-living
- Self-reported chronic musculoskeletal pain > 3 months having pain made it difficult to do usual activities
- Ability to attend sessions one in a week for 6-weeks
Exclusion Criteria:
- Serious illness or hospitalisation in last 3-month
- Planned surgery in next six months
- Significant cognitive impairment
- Other severe physical or psychiatric disorder
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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EXPERIMENTAL: Integrative Yoga Therapy
Participants engaging in a 6-week chronic pain self-management program.
Intervention: Integrative Yoga Therapy
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Participants having an hour in-person weekly session with qualified yoga therapist for 6-weeks.
At each session, the personalised yoga practices including straightening and relaxing posture of yoga, yoga breathing, Combinations of sound and imagery yoga practices were given and asked to continue practice at home during the week.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain severity and interference: Brief Pain Inventory (BPI) questionnaire
Time Frame: From baseline to 6-week post intervention
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Pain severity and interference were evaluated by using the Brief Pain Inventory (BPI) questionnaire.
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From baseline to 6-week post intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Participant Global Impression of Change
Time Frame: From baseline to 6-week post intervention
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Participant Global Impression of Change included 2 item the change from baseline
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From baseline to 6-week post intervention
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Participant satisfaction: Likert-scale questions
Time Frame: From baseline to 6-week post intervention
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Likert-scale questions score between 1-5 for participant satisfaction with the program (Strongly Agree=1 to Strongly Disagree=5)
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From baseline to 6-week post intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Usha Solanki, Hindu Swayamsevak Sangh (UK)
- Study Chair: Bharti Mistry, Leicester Ageing Together UK
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 28, 2019
Primary Completion (ACTUAL)
February 28, 2020
Study Completion (ACTUAL)
March 7, 2020
Study Registration Dates
First Submitted
March 17, 2020
First Submitted That Met QC Criteria
March 18, 2020
First Posted (ACTUAL)
March 20, 2020
Study Record Updates
Last Update Posted (ACTUAL)
March 20, 2020
Last Update Submitted That Met QC Criteria
March 18, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AU06
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.