Horses and Education as Arthritis Therapy

Arthritis Clinical Trial

— HEAT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03141853
• Other study ID #: 16-276
• Status: Completed
• Phase: N/A
• First received: March 20, 2017
• Last updated: January 22, 2018
• Start date: May 20, 2017
• Est. completion date: December 20, 2017

Study information

• Verified date: January 2018
• Source: University of Missouri, Kansas City
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 20, 2017
• Est. primary completion date: December 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Due West Therapeutic Riding Center	Kansas City	Kansas
United States	Kansas City Physician's Partners	Kansas City	Missouri
United States	Saint Luke's College of Health Sciences	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri, Kansas City

Country where clinical trial is conducted

United States, 

References & Publications (63)

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* Note: There are 63 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Exclusion of Participants - This is measured by number of participants that meet exclusion criteria	Reasons for exclusion will be aggregated and reported	Week 0
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Missing Data - Missing data will be counted	Missing data will be identified and counted.	8 Weeks
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Pain	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
Secondary	Range of Motion	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
Secondary	Serum Troponin	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
Secondary	Cartilage Oligomeric Matrix Protein (COMP) Biomarker	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
Secondary	Quality of Life	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
Secondary	Enjoyment of Nature	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

External Links

•   Arthritis Impact Measurement Scale 2
•   Environmental Attitudes Inventory Scale
•   Range of Joint Motion Evaluation Chart
•   Visual Analog Scale