Horses and Education as Arthritis Therapy

Study Overview
=================
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.

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.

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

Conditions
-----------------
Arthritis

Intervention / Treatment
-----------------
* Other: Equine-assisted Therapy
* Other: Arthritis Exercise Education


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled Trial. One group will receive equine-assisted therapy and the second group will receive arthritis exercise education
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Equine-assisted Therapy Group<br>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<br>* 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<br>* Other names: Therapeutic Horseback Riding;|
| Placebo Comparator: Arthritis Exercise Education Group<br>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<br>* 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<br>|

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 | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Randomized Controlled Trial, Intervention Study