NCT02528084

Brief Summary

To determine if patients who undergo a 6-week online yoga exercise treatment differ from those who undergo a 6-week online standard exercise intervention and patients who do not undergo any treatment (the control).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 19, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

October 20, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2016

Completed
Last Updated

March 24, 2017

Status Verified

March 1, 2017

Enrollment Period

1 year

First QC Date

August 13, 2015

Last Update Submit

March 22, 2017

Conditions

Keywords

rotator cuff, shoulder, rehabilitation, yoga

Outcome Measures

Primary Outcomes (2)

  • Shoulder Pain and Disability Index (Pain Level)

    Shoulder Pain and Disability Index (self-report)

    6 weeks

  • Range of motion (Shoulder Impairment)

    Shoulder range of motion will be measured using a goniometer (performance-based).

    6 weeks

Secondary Outcomes (1)

  • Treatment satisfaction

    6 weeks

Study Arms (3)

yoga intervention

EXPERIMENTAL

patients in the group are asked to follow an online video instructing them various yoga poses. Patients in this group are asked to do the yoga exercises 2-3 times a week, for a total of 6 weeks.

Procedure: yoga

standard exercises intervention

EXPERIMENTAL

patients in this group are asked to follow an online standard exercises video. Patients in this group are asked to follow specific exercises 2-3 times a day, for a total of 6 weeks.

Procedure: standard exercises

control

NO INTERVENTION

patients in this group carry forth with their daily activities. They are not asked to follow the online yoga video or the online standard exercise video.

Interventions

yogaPROCEDURE

patients watch and follow an online yoga video.

yoga intervention

patients watch and follow an online standard exercises video.

standard exercises intervention

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • minimum 18 years old
  • rotator cuff injury
  • access to YouTube

You may not qualify if:

  • under 18 years of age
  • patient has past yoga experience
  • patient will/has undergone any surgery other than rotator cuff

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Joseph Health Care

London, Ontario, N6A 4L6, Canada

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Yoga

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Joy MacDermid, PhD

    Western University, Canada

    PRINCIPAL INVESTIGATOR
  • Dolly Mehta, M.Sc.

    Western University, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co-Director, Hand and Upper Limb Clinical Research Lab

Study Record Dates

First Submitted

August 13, 2015

First Posted

August 19, 2015

Study Start

October 20, 2015

Primary Completion

October 20, 2016

Study Completion

October 20, 2016

Last Updated

March 24, 2017

Record last verified: 2017-03

Locations