Effect of Sukshma Vyayama Yoga on Aromatase Inhibitor-Induced Arthralgia in Breast Cancer Survivors

NCT04042870 | Completed

• 1 other identifier: AI Yoga Study on Facebook - 1
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the efficacy of sukshma vyayama joint loosening yoga in improving aromatase inhibitor-induced arthralgia in post-menopausal breast cancer survivors and secondarily, to evaluate the feasibility of delivering the intervention on Facebook.

Conditions

Breast Cancer

Keywords

Breast Cancer; Yoga; Aromatase Inhibitor; Arthralgia; Sukshma Vyayama

Outcome Measures

Primary Outcomes (5)

• Change in Patient-Reported Arthralgia Inventory (PRAI) Measure for Joint Arthralgia

  The Patient-Reported Arthralgia Inventory measures self-reported pain intensity in 16 specific joints over the past 7 days. This questionnaire consists of 16 questions answered on a 0 to 10 scale (0 = no pain at all; 10 = worst pain you can imagine) with a min of 0 and a max of 160. Higher scores indicate more pain.

  Baseline and Four weeks

• Change in Brief Pain Inventory Short Form (BPI SF) Measure for Body Pain

  The Brief Pain Inventory Short Form measures self-reported pain intensity in the body in the last 24-hours. This questionnaire consists of 8 questions (4 on pain quality) answered on a scale 0-10 (0 = no pain; 10 = pain as bad as you can imagine) with a min of 0 and a max of 40. Higher scores indicate more pain.

  Baseline and Four weeks

• Change in Brief Pain Inventory Short Form (BPI SF) Measure for Quality of Life

  The Brief Pain Inventory Short Form measures self-reported QoL in the last 24-hours. This questionnaire consists of 7 questions answered on a scale 0-10 (0 = does not interfere; 10 = completely interferes) with a min of 0 and a max of 70. Higher scores indicate lower QoL.

  Baseline and Four weeks

• Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Measure for Pain, Stiffness, and Physical Function of Knee and Hip

  The Western Ontario and McMaster Universities Osteoarthritis Index measures self-reported pain, stiffness, and functional limitation of knee and hip during activity in the last 48-hours. This questionnaire consists of 24 questions answered on a scale 0-4 (0 = none; 4 = extreme). Measures include five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). Higher scores indicate greater pain, stiffness, and functional limitation.

  Baseline and Four weeks

• Change in Disability of the Arm, Shoulder and Hand (DASH) Measure of Ability to Use Arm, Shoulder, and Hand

  The Disability of the Arm, Shoulder and Hand tool measures self-reported ability to do daily activities in the last week and impact on QoL. The questionnaire consists of 30 questions answered on a scale 1-5 (1 = no difficulty; 5 = unable) with a min of 30 and a max of 150. Measures include 21 items for daily functional activity (score range 30-105), two for interference with social or work activity (score range 2-10), five for pain and discomfort (score range 5-25), one for sleep (score range 1-5), and one for confidence (score range 1-5). Higher scores indicate greater pain and disability.

  Baseline and Four weeks

Secondary Outcomes (1)

• Effectiveness of Delivering Intervention on Facebook

  Four Weeks

Study Arms (1)

Joint Loosening Yoga

EXPERIMENTAL

Yoga Intervention. Dose: 15 minutes, M-F for 4-weeks.

Behavioral: Joint Loosening Yoga

Interventions

Joint Loosening Yoga BEHAVIORAL

Sukshma Vyayama Joint Loosening Yoga was practiced Monday - Friday for four weeks. Each session included twelve joint loosening exercises performed in a chair, each performed 10 times with mindful awareness of physical movements and breath synchronization. Sessions lasted 15 minutes.

Joint Loosening Yoga

Eligibility Criteria

• Age: 35 Years - 70 Years
• Gender Eligibility Details: Women with estrogen receptor-positive breast cancer prescribed and currently taking aromatase inhibitor therapy.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal breast cancer survivors undergoing treatment with aromatase inhibitor hormonal therapy with self-reported arthralgia
• Must have initiated anastrazole, exemestane, or letrozole within 30 days of baseline assessment
• years old
• Must be available during the dates of the study and willing to participate in the study
• Must have access to computer, tablet or smart phone and Internet connection
• Must be a member of Facebook
• Eligible if their arthralgia started after initiation of an AI or if they had preexisting joint pain that was exacerbated by AI use
• English speaking

You may not qualify if:

• Non English-speaking
• Physically unable to perform the intervention

Sponsors & Collaborators

• AshtaYoga, LLC: lead
• Columbia University: collaborator
• Swami Vivekananda Yoga Anusandhana Samsthana: collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (1)

• Leibel L, Metri K, Prasad R, Mears JG, Effect of Sukshma Vyayama on Aromatase Inhibitor-Induced Arthralgia in Post-Menopausal Breast Cancer Survivors: A Feasibility Study Conducted on Facebook, J Clin Oncol 37, 2019 (suppl; abstr e23129)

  RESULT

MeSH Terms

Conditions

Breast Neoplasms; Arthralgia

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Leigh Leibel, MSc

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Pre / Post Single Control

Study Record Dates

• First Submitted: July 14, 2019
• First Posted: August 2, 2019
• Study Start: September 4, 2018
• Primary Completion: September 28, 2018
• Study Completion: October 19, 2018
• Last Updated: August 2, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)