Clinical trial NCT03141853: Horses and Education as Arthritis Therapy
Official title: Equine-assisted Therapy for Adults and Older Adults With Arthritis: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthritis
Keywords: Randomized Controlled Trial
Intervention Study
Lead sponsor: University of Missouri, Kansas City
Sponsor class: OTHER
First posted: 2017-05-05
Enrollment: 21
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial. One group will receive equine-assisted therapy and the second group will receive arthritis exercise education
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Attendance - Measured by number of participants attending each arm of the study
timeFrame: 0, 1, 2, 3, 4, 5, and week 6
measure: Recruitment - Data will be measured according to number of participants.
timeFrame: Prior to and including Week 1 of the study
measure: Implementation - This will be measured by completed Protocol Impediment Form
timeFrame: Measured after week 6
measure: Fidelity to the Protocol - This is measured by a researcher or research assistant observing with a protocol checklist.
timeFrame: 0, 1, 2, 3, 4, 5, and week 6
measure: Recruitment Procedure Sequence - This will be measured by number of participants
timeFrame: Week 0, 1
measure: Exclusion of Participants - This is measured by number of participants that meet exclusion criteria
timeFrame: Week 0
measure: Attrition - This is measured by the number of participants enrolled vs. completion of the study
timeFrame: 0, 6 weeks
measure: Completeness - This will be measured by number of Protocol Impediment incidences, Protocol violations noted on the Protocol checklists.
timeFrame: 0, 1, 2, 3, 4, 5, and week 6
measure: Timing - measured by minutes for each major protocol step
timeFrame: 0, 1, 2, 3, 4, 5, and 6 Weeks
measure: Compliance - This will be measured by number of Protocol Violations due to refusal or inability to comply with the protocol
timeFrame: 0, 1, 2, 3, 4, 5, and 6 Weeks
measure: Missing Data - Missing data will be counted
timeFrame: 8 Weeks
measure: Acceptability of the protocol - measured by Exit Survey Questionaire
timeFrame: 6 Weeks
measure: Continuing the intervention - Measured by self reported affirmative responses
timeFrame: 8 Weeks
measure: Migration - Measured by number of requests to move from assigned groups
timeFrame: 0, 1, 2, 3, 4, 5, and 6 Weeks
measure: Blinding - Measured by number of responses of participants checking if they were in the intervention or control group
timeFrame: 6 Weeks
measure: Length of Study Visits - Measured by number of responses on a Likert scale on Exit survey
timeFrame: 6 Weeks
measure: Length of Overall Study - Measured by number of responses on Exit survey Likert scale
timeFrame: 6 Weeks
measure: Measurement - Measured by number of responses on Exit Survey - Yes/No
timeFrame: 6 Weeks
measure: Study Improvement - Measured by comments for improvement
timeFrame: 6 Weeks
Secondary outcomes:
measure: Pain
timeFrame: 0, 3, and 6 Weeks
measure: Range of Motion
timeFrame: 0, 3, and 6 Weeks
measure: Serum Troponin
timeFrame: 0 and 6 Weeks
measure: Cartilage Oligomeric Matrix Protein (COMP) Biomarker
timeFrame: 0 and 6 Weeks
measure: Quality of Life
timeFrame: 0, 3, and 6 Weeks
measure: Enjoyment of Nature
timeFrame: 0, 3, and 6 Weeks
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Due West Therapeutic Riding Center
state: Kansas
city: Kansas City
country: United States
facility: Kansas City Physician's Partners
state: Missouri
city: Kansas City
country: United States
facility: Saint Luke's College of Health Sciences
state: Missouri
Study officials:
affiliation: University of Missouri, Kansas City
name: Cynthia L Russell, PhD
role: STUDY_CHAIR
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