Horses and Education as Arthritis Therapy (HEAT)

January 22, 2018 updated by: University of Missouri, Kansas City

Equine-assisted Therapy for Adults and Older Adults With Arthritis: A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of the proposed research is to assess the feasibility, acceptability and effects of equine-assisted therapy on adults and older adults with arthritis. Equine-assisted therapy (EAT) is defined as any intervention using the unique qualities of horses to improve social, gross motor, and self-help skills.(Ratliffe & Sanekane, 2009) Although equine therapy has been used as a medical intervention since the second century (Ratliffe & Sanekane, 2009), no research has been conducted using equine-assisted therapy to improve arthritis.

In the United States arthritis accounts for $128 billion in lost income and medical costs (Centers for Disease Control and Prevention (CDC), 2013) Incidence of arthritis is increasing due to obesity and an aging population.(Bijlsma, Berenbaum, & Lafeber, 2011) Adults aged 40 to 65 and older than 65 with arthritis experience joint pain, stiffness, damage to cartilage, and decreased range of motion particularly in hips, knees, shoulders, and back (Barten et al., 2015; George et al., 2015; Karjalainen et al., 2001). Practice recommendations of non-pharmacological management of arthritis include using a biopsychosocial approach, an individualized exercise regime, strengthening leg and hip muscles, and improving the range of motion for muscle and joint health (Fernandes et al., 2013). Healthy People 2020 reports that arthritis has a major effect on a person's quality of life, ability to work and activities of daily life with the objectives of decreasing joint pain, decrease limitations, and decreasing psychological stress. Improving arthritis includes decreasing pain and improving the arthritic impact on the individual's quality of life.(Buchbinder, Bombardier, Yeung, & Tugwell, 1995) To improve musculoskeletal and functional health, the (World Health Organization, 2010) recommends physical activity including aerobic physical activity, strength, flexibility and balance. Current treatments include the use of physical conditioning (Schaafsma et al., 2013), opioids (Chaparro et al., 2013), and injections of anti-inflammatory medications, morphine, anesthetics or steroids(Staal, de Bie, De Vet, Hildebrandt, & Nelemans, 2008). The side effects from these medications can be bothersome, thus non-pharmacologic interventions must be further explored to improve adults and older adults with arthritis. Equine assisted therapy is a promising option since unique movements of the horse translate tri-rotational movements from the horse to the human (Selby & Smith-Osborne, 2013). This targets the spine and hip joints by non-weight bearing movement and has the potential to improve outcomes without joint damage.

There are both physical and psychosocial medical uses for equine assisted therapy. Previous meta-analyses of horses used to improve cerebral palsy in children, provide evidence to support the physical-neuromuscular connection and improvements in outcomes (Nimer & Lundahl, 2007; Pretty et al., 2007; Tseng, Chen, & Tam, 2013) reported significant improvement in total mood when riding horses. Anticipated implications for this research include improved range of motion, decreased pain, improved quality of life and enjoyment of nature. The bio-markers will assess the implications on cartilage and muscle to monitor improvement, destruction, or maintenance of both during equine-assisted therapy. If quality of life, enjoyment of nature and range of motion increase without muscle or cartilage destruction, then this would present evidence that EAT is a viable and desirable intervention and this will lead to further research for arthritis interventions including equines.

Study Type

Interventional

Enrollment (Actual)

21

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

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66109
        • Due West Therapeutic Riding Center
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Kansas City Physician's Partners
      • Kansas City, Missouri, United States, 64111
        • Saint Luke's College of Health Sciences

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

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- Ages 45 and older

Joint pain inclusion will be considered with a mild [Mild pain (0-44)] to moderate pain level [Moderate pain (45-74 mm)] (Hawker, Mian, Kendzerska, & French, 2011) not completely relieved by medications.

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.

Exclusion Criteria:

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.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Equine-assisted Therapy Group
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
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
Other Names:
  • Hippotherapy
  • Therapeutic Horseback Riding
Placebo Comparator: Arthritis Exercise Education Group
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Attendance - Measured by number of participants attending each arm of the study
Time Frame: 0, 1, 2, 3, 4, 5, and week 6
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.
Time Frame: Prior to and including Week 1 of the study
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
Time Frame: Measured after week 6
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.
Time Frame: 0, 1, 2, 3, 4, 5, and week 6
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
Time Frame: Week 0, 1
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
Time Frame: Week 0
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
Time Frame: 0, 6 weeks
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.
Time Frame: 0, 1, 2, 3, 4, 5, and week 6
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
Time Frame: 0, 1, 2, 3, 4, 5, and 6 Weeks
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
Time Frame: 0, 1, 2, 3, 4, 5, and 6 Weeks
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
Time Frame: 8 Weeks
Missing data will be identified and counted.
8 Weeks
Acceptability of the protocol - measured by Exit Survey Questionaire
Time Frame: 6 Weeks
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
Time Frame: 8 Weeks
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
Time Frame: 0, 1, 2, 3, 4, 5, and 6 Weeks
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
Time Frame: 6 Weeks
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
Time Frame: 6 Weeks
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
Time Frame: 6 Weeks
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
Time Frame: 6 Weeks
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
Time Frame: 6 Weeks
Any other suggestions for improving the study. Responses for improvement will be asked, documented and collated for themes.
6 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain
Time Frame: 0, 3, and 6 Weeks
What is the effect of an equine-assisted therapy intervention compared to an exercise attention-control intervention on pain in adults and older adults with arthritis? Visual Analog Pain Scale will be used to measure
0, 3, and 6 Weeks
Range of Motion
Time Frame: 0, 3, and 6 Weeks
What is the effect of an equine-assisted therapy intervention compared to an exercise attention-control intervention on range of motion in adults and older adults with arthritis? Goniometer will measure joint range of motion
0, 3, and 6 Weeks
Serum Troponin
Time Frame: 0 and 6 Weeks
What is the effect of an equine-assisted therapy intervention compared to an exercise attention-control intervention on serum troponin for muscle in adults and older adults with arthritis? Serum Troponin will be used to measure this.
0 and 6 Weeks
Cartilage Oligomeric Matrix Protein (COMP) Biomarker
Time Frame: 0 and 6 Weeks
What is the effect of an equine-assisted therapy intervention compared to an exercise attention-control intervention on Cartilage Oligomeric Matrix Protein biomarker for cartilage in adults and older adults with arthritis? Serum COMP will be measured
0 and 6 Weeks
Quality of Life
Time Frame: 0, 3, and 6 Weeks
What is the effect of an equine-assisted therapy intervention compared to an exercise attention-control intervention on quality of life in adults and older adults with arthritis? Arthritis Impact Measurement Scale 2 (AIMS 2) short-form will be used to measure this.
0, 3, and 6 Weeks
Enjoyment of Nature
Time Frame: 0, 3, and 6 Weeks
What is the effect of an equine-assisted therapy intervention compared to an exercise attention-control intervention on enjoyment of nature in adults and older adults with arthritis? Environmental Attitudes Inventory Scale Sub-scale #1 will measure this.
0, 3, and 6 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Missouri, Kansas City

Investigators

  • Study Chair: Cynthia L Russell, PhD, University of Missouri, Kansas City

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

May 20, 2017

Primary Completion (Actual)

December 20, 2017

Study Completion (Actual)

December 20, 2017

Study Registration Dates

First Submitted

March 20, 2017

First Submitted That Met QC Criteria

May 2, 2017

First Posted (Actual)

May 5, 2017

Study Record Updates

Last Update Posted (Actual)

January 24, 2018

Last Update Submitted That Met QC Criteria

January 22, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-276

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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.

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