Back to resultsSelf-managed Integrative Yoga Therapy for Older Adults Living With Chronic Pain
Primary Purpose
Chronic Pain
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Integrative Yoga Therapy
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Pain
Eligibility Criteria
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
Sites / Locations
- Karyalaya
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Integrative Yoga Therapy
Arm Description
Participants engaging in a 6-week chronic pain self-management program. Intervention: Integrative Yoga Therapy
Outcomes
Primary Outcome Measures
Pain severity and interference: Brief Pain Inventory (BPI) questionnaire
Pain severity and interference were evaluated by using the Brief Pain Inventory (BPI) questionnaire.
Secondary Outcome Measures
Participant Global Impression of Change
Participant Global Impression of Change included 2 item the change from baseline
Participant satisfaction: Likert-scale questions
Likert-scale questions score between 1-5 for participant satisfaction with the program (Strongly Agree=1 to Strongly Disagree=5)
Full Information
NCT ID
NCT04316455
First Posted
March 17, 2020
Last Updated
March 18, 2020
Sponsor
Aarogyam UK
Collaborators
Hindu Swayamsevak Sangh (UK), Leicester Ageing Together
1. Study Identification
Unique Protocol Identification Number
NCT04316455
Brief Title
Self-managed Integrative Yoga Therapy for Older Adults Living With Chronic Pain
Official Title
Impact of Self-managed Integrative Yoga Therapy for Older Adults Living With Chronic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
October 28, 2019 (Actual)
Primary Completion Date
February 28, 2020 (Actual)
Study Completion Date
March 7, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aarogyam UK
Collaborators
Hindu Swayamsevak Sangh (UK), Leicester Ageing Together
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Integrative Yoga Therapy
Arm Type
Experimental
Arm Description
Participants engaging in a 6-week chronic pain self-management program. Intervention: Integrative Yoga Therapy
Intervention Type
Other
Intervention Name(s)
Integrative Yoga Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain severity and interference: Brief Pain Inventory (BPI) questionnaire
Description
Pain severity and interference were evaluated by using the Brief Pain Inventory (BPI) questionnaire.
Time Frame
From baseline to 6-week post intervention
Secondary Outcome Measure Information:
Title
Participant Global Impression of Change
Description
Participant Global Impression of Change included 2 item the change from baseline
Time Frame
From baseline to 6-week post intervention
Title
Participant satisfaction: Likert-scale questions
Description
Likert-scale questions score between 1-5 for participant satisfaction with the program (Strongly Agree=1 to Strongly Disagree=5)
Time Frame
From baseline to 6-week post intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neha Sharma, PhD
Organizational Affiliation
Aarogyam UK
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jaydeep Joshi, BAMS
Organizational Affiliation
Aarogyam UK
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Usha Solanki
Organizational Affiliation
Hindu Swayamsevak Sangh (UK)
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Bharti Mistry
Organizational Affiliation
Leicester Ageing Together UK
Official's Role
Study Chair
Facility Information:
Facility Name
Karyalaya
City
Leicester
State/Province
Leicestershire
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Self-managed Integrative Yoga Therapy for Older Adults Living With Chronic Pain
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