Horses and Education as Arthritis Therapy

NCT03141853 | Completed

• 1 other identifier: 16-276
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 3

Brief Summary

A study will be conducted to assess if adults and older adults with arthritis who ride horses are able to move better, have less pain, enjoy nature more and have a better quality of life then people who go to class to learn about exercise. This is needed because adults with arthritis experience joint pain, stiffness, damage to their cartilage, and decreased range of motion in their hips, knees, shoulders, and back. This study will measure effects on patient's joints, pain, quality of life, muscle and cartilage before and after either arthritis exercise education or horse riding. Horses have unique movements that target joints without weight bearing and possibly show improvements without joint damage. Twenty two subjects will be assigned to either the equine-assisted therapy (EAT) group or a group receiving exercise education for 1 hour each week for 6 weeks. Outcomes of pain, joint mobility and quality of life are measured at 0, 3 and 6 weeks. Enjoyment will be determined by a survey. Safety procedures include helmets, side walking attendants for balance, and controlled by a certified riding instructor at a certified riding center. Data will be gathered and reviewed, to assess the effects of EAT on arthritis.

Conditions

Arthritis

Keywords

Randomized Controlled Trial; Intervention Study

Outcome Measures

Primary Outcomes (19)

• Attendance - Measured by number of participants attending each arm of the study

  Data on attendance will be collected at 0 (screening), 1, 2, 3, 4, 5, and week 6. Tracking of de-identified will be measured. Data will be aggregated according to intervention vs. control group.

  0, 1, 2, 3, 4, 5, and week 6

• Recruitment - Data will be measured according to number of participants.

  Participant data will include: : Identified, Approached, Screened, Consented, and attending week 1 of either intervention

  Prior to and including Week 1 of the study

• Implementation - This will be measured by completed Protocol Impediment Form

  Each time a roadblock or difficulty in implementation occurs a Protocol Impediment Form will be completed. Data from these forms will be aggregated for reporting of findings from the study

  Measured after week 6

• Fidelity to the Protocol - This is measured by a researcher or research assistant observing with a protocol checklist.

  Each time there is a Protocol Violation the researcher or Research Assistant will correct the violation and mark that is was corrected. Data will be aggregated and reported for protocol violations in each arm

  0, 1, 2, 3, 4, 5, and week 6

• Recruitment Procedure Sequence - This will be measured by number of participants

  Number of participants approached will be compared to number of participants who meet inclusion criteria and then start week 1.

  Week 0, 1

• Exclusion of Participants - This is measured by number of participants that meet exclusion criteria

  Reasons for exclusion will be aggregated and reported

  Week 0

• Attrition - This is measured by the number of participants enrolled vs. completion of the study

  Attrition rate will be calculated and reported

  0, 6 weeks

• Completeness - This will be measured by number of Protocol Impediment incidences, Protocol violations noted on the Protocol checklists.

  Incidents of incomplete protocol will be measured, calculated and aggregated by Protocol step

  0, 1, 2, 3, 4, 5, and week 6

• Timing - measured by minutes for each major protocol step

  Planned time vs. actual time for protocol steps will be collected and aggregated.

  0, 1, 2, 3, 4, 5, and 6 Weeks

• Compliance - This will be measured by number of Protocol Violations due to refusal or inability to comply with the protocol

  Protocol Violations will be categorized into researcher violations, participant violations, therapeutic riding instructor violations.

  0, 1, 2, 3, 4, 5, and 6 Weeks

• Missing Data - Missing data will be counted

  Missing data will be identified and counted.

  8 Weeks

• Acceptability of the protocol - measured by Exit Survey Questionaire

  Open ended question will be administered upon exit of the study asking about acceptability of the study protocol for each arm

  6 Weeks

• Continuing the intervention - Measured by self reported affirmative responses

  Do the study participants intend to continue the intervention after the end of the study? This will be asked at the end of the study and a follow-up phone call to assess if they continued will be made at 8 weeks. Data will be aggregated and reported.

  8 Weeks

• Migration - Measured by number of requests to move from assigned groups

  Do the participants stay in the assigned groups, e.g. not wanting to move from control group to treatment group? Note of any desire to change groups will be documented and counted. Data will be aggregated and reported.

  0, 1, 2, 3, 4, 5, and 6 Weeks

• Blinding - Measured by number of responses of participants checking if they were in the intervention or control group

  Do participants know that they are in the treatment group or control group at the end of the study? At the conclusion of the study this will be asked. Data will be aggregated and reported.

  6 Weeks

• Length of Study Visits - Measured by number of responses on a Likert scale on Exit survey

  Do the participants feel the time spent per session is too long, too short, or just right? This will be asked at the conclusion of the study. Data will be aggregated and reported.

  6 Weeks

• Length of Overall Study - Measured by number of responses on Exit survey Likert scale

  Do the participants feel the time spent in the study (6 weeks) was too long, too short or just right? This will be asked at the conclusion of the study. Data will be aggregated and reported.

  6 Weeks

• Measurement - Measured by number of responses on Exit Survey - Yes/No

  Do the participants feel the measures were too extensive. This will be asked and measured at the conclusion of the study. Data will be aggregated and reported.

  6 Weeks

• Study Improvement - Measured by comments for improvement

  Any other suggestions for improving the study. Responses for improvement will be asked, documented and collated for themes.

  6 Weeks

Secondary Outcomes (6)

• Pain

  0, 3, and 6 Weeks

• Range of Motion

  0, 3, and 6 Weeks

• Serum Troponin

  0 and 6 Weeks

• Cartilage Oligomeric Matrix Protein (COMP) Biomarker

  0 and 6 Weeks

• Quality of Life

  0, 3, and 6 Weeks

Study Arms (2)

Equine-assisted Therapy Group

EXPERIMENTAL

This group will interact and ride horses for 1 hour each week for 6 weeks. Horses will remain at a walk and an standard Therapeutic Riding curriculum will be used including safety, mounting, riding, tasks while riding, dismount, bonding with the horse.

Other: Equine-assisted Therapy

Arthritis Exercise Education Group

PLACEBO COMPARATOR

This group will receive exercise education that targets arthritis symptoms for 1 hour each week for 6 weeks. This will be based on the exercise education from the Arthritis foundation How-to Exercise With Arthritis. (n.d.).

Other: Arthritis Exercise Education

Interventions

Equine-assisted Therapy OTHER

Participants will groom and ride horses. Horses will be kept at a walk with tasks such as serpentine, circles, and zig zags to complete. Stretching, and tasks like throwing a ball into a net from horseback will be completed

Also known as: Hippotherapy, Therapeutic Horseback Riding

Equine-assisted Therapy Group

Arthritis Exercise Education OTHER

Standard of Care from the Arthritis Foundation - How-to Exercise With Arthritis. (n.d.). Retrieved April 18, 2016, from http://www.arthritis.org/living-with-arthritis/exercise/how-to). This intervention will consist of 6 -1 hour education sessions once a week on exercise to improve symptoms of arthritis

Arthritis Exercise Education Group

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Ages 45 and older
• Measured decreased range of motion by 20% (back, shoulder, knee and hip) and hip abduction wide enough to straddle a horse without discomfort.
• Written physician's or advanced practice registered nurse's (APRN) clearance to ride a horse.
• Ability to read and understand English as evidenced by the capacity to follow verbal and written directions at the screening interview.

You may not qualify if:

• Self-reported: fear of horses.
• Self reported allergies to horses.
• Self reported osteoporosis.
• Inability to abduct hips wide enough to straddle a horse comfortably.
• Lack of transportation to the Therapeutic Riding Center.
• Horse riding for the previous six months.

Sponsors & Collaborators

• University of Missouri, Kansas City: lead

Study Sites (3)

Due West Therapeutic Riding Center

Kansas City, Kansas, 66109, United States

Location

Kansas City Physician's Partners

Kansas City, Missouri, 64111, United States

Location

Saint Luke's College of Health Sciences

Kansas City, Missouri, 64111, United States

Location

Related Publications (63)

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Related Links

• Arthritis Impact Measurement Scale 2
• Range of Joint Motion Evaluation Chart

MeSH Terms

Conditions

Arthritis

Interventions

Equine-Assisted Therapy

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Animal Assisted Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Cynthia L Russell, PhD

  University of Missouri, Kansas City

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants, care provider, and outcomes assessor will be masked as to which is the intervention and which is the control
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Trial. One group will receive equine-assisted therapy and the second group will receive arthritis exercise education

Study Record Dates

• First Submitted: March 20, 2017
• First Posted: May 5, 2017
• Study Start: May 20, 2017
• Primary Completion: December 20, 2017
• Study Completion: December 20, 2017
• Last Updated: January 24, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)