ArthritisHEATNCT03141853
Horses and Education as Arthritis Therapy
A study testing Equine-assisted Therapy and Arthritis Exercise Education in people with Arthritis, run by University of Missouri, Kansas City at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Arthritis
- What is being tested?
- Equine-assisted Therapy and Arthritis Exercise Education
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 3 sitesUnited States
- Study dates
- 20 May 2017to 20 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Due West Therapeutic Riding Center
Kansas City, Kansas, 66109
Kansas City Physician's Partners
Kansas City, Missouri, 64111
Saint Luke's College of Health Sciences
Kansas City, Missouri, 64111
About this study
Official title: 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.
Read the 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.
- Conditions
- Arthritis
- Being tested
- Equine-assisted Therapy, Arthritis Exercise Education
- Keywords
- Randomized Controlled Trial, Intervention Study
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Equine-assisted TherapyOther
Also called Hippotherapy, Therapeutic Horseback Riding
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 EducationOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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.). Receives: Other: Arthritis Exercise Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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: 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
Measured: 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.
Measured: 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
Measured: Week 0
Attrition - This is measured by the number of participants enrolled vs. completion of the study
Attrition rate will be calculated and reported
Measured: 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
Measured: 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.
Measured: 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.
Measured: 0, 1, 2, 3, 4, 5, and 6 Weeks
Missing Data - Missing data will be counted
Missing data will be identified and counted.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 Weeks
Secondary outcomes (6)
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
Measured: 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
Measured: 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.
Measured: 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
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.
Measured: 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.
Measured: 0, 3, and 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2017
- Study start20 May 2017
- Primary completion20 Dec 2017
- Study completion20 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (63)Papers the sponsor has linked to this study.
- Other trials for ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial. One group will receive equine-assisted therapy and the second group will receive arthritis exercise education
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri, Kansas City
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cynthia L Russell, PhD, Study chair, University of Missouri, Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03141853
- Sponsor's protocol ID
- 16-276
- Acronym
- HEAT
- Status last verified
- Jan 2018
- First submitted
- 20 Mar 2017
- Last updated
- 24 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aranda-Garcia S, Iricibar A, Planas A, Prat-Subiran JA, Angulo-Barroso RM. Comparative effects of horse exercise versus traditional exercise programs on gait, muscle strength, and body balance in healthy older adults. J Aging Phys Act. 2015 Jan;23(1):78-89. doi: 10.1123/japa.2012-0326. Epub 2014 Jan 14.
PubMed 24425454Araujo TB, Silva NA, Costa JN, Pereira MM, Safons MP. Effect of equine-assisted therapy on the postural balance of the elderly. Rev Bras Fisioter. 2011 Sep-Oct;15(5):414-9. doi: 10.1590/s1413-35552011005000027. Epub 2011 Oct 14. English, Portuguese.
PubMed 22002189Barten DJ, Swinkels LC, Dorsman SA, Dekker J, Veenhof C, de Bakker DH. Treatment of hip/knee osteoarthritis in Dutch general practice and physical therapy practice: an observational study. BMC Fam Pract. 2015 Jun 27;16:75. doi: 10.1186/s12875-015-0295-9.
PubMed 26116374Beil K, Hanes D. The influence of urban natural and built environments on physiological and psychological measures of stress--a pilot study. Int J Environ Res Public Health. 2013 Mar 26;10(4):1250-67. doi: 10.3390/ijerph10041250.
PubMed 23531491Beinotti F, Christofoletti G, Correia N, Borges G. Effects of horseback riding therapy on quality of life in patients post stroke. Top Stroke Rehabil. 2013 May-Jun;20(3):226-32. doi: 10.1310/tsr2003-226.
PubMed 23841970Beinotti F, Correia N, Christofoletti G, Borges G. Use of hippotherapy in gait training for hemiparetic post-stroke. Arq Neuropsiquiatr. 2010 Dec;68(6):908-13. doi: 10.1590/s0004-282x2010000600015.
PubMed 21243251Bijlsma JW, Berenbaum F, Lafeber FP. Osteoarthritis: an update with relevance for clinical practice. Lancet. 2011 Jun 18;377(9783):2115-26. doi: 10.1016/S0140-6736(11)60243-2.
PubMed 21684382Bizub AL, Joy A, Davidson L. "It's like being in another world": demonstrating the benefits of therapeutic horseback riding for individuals with psychiatric disability. Psychiatr Rehabil J. 2003 Spring;26(4):377-84. doi: 10.2975/26.2003.377.384.
PubMed 12739908Boonstra AM, Schiphorst Preuper HR, Reneman MF, Posthumus JB, Stewart RE. Reliability and validity of the visual analogue scale for disability in patients with chronic musculoskeletal pain. Int J Rehabil Res. 2008 Jun;31(2):165-9. doi: 10.1097/MRR.0b013e3282fc0f93.
PubMed 18467932Borioni N, Marinaro P, Celestini S, Del Sole F, Magro R, Zoppi D, Mattei F, Dall' Armi V, Mazzarella F, Cesario A, Bonassi S. Effect of equestrian therapy and onotherapy in physical and psycho-social performances of adults with intellectual disability: a preliminary study of evaluation tools based on the ICF classification. Disabil Rehabil. 2012;34(4):279-87. doi: 10.3109/09638288.2011.605919. Epub 2011 Oct 12.
PubMed 21988646Boswell, S., Gusowski, K., Kaiser, A., & Flachenecker, P. (2009). Hippotherapy in multiple sclerosis - results of a prospective, controlled, randomised and single-blind trial. Poster presentation.
Brock, B.J, (1988). Effect of therapeutic horseback riding on physically disabled adults
Buchbinder R, Bombardier C, Yeung M, Tugwell P. Which outcome measures should be used in rheumatoid arthritis clinical trials? Clinical and quality-of-life measures' responsiveness to treatment in a randomized controlled trial. Arthritis Rheum. 1995 Nov;38(11):1568-80. doi: 10.1002/art.1780381108.
PubMed 7488277Burch PM, Pogoryelova O, Goldstein R, Bennett D, Guglieri M, Straub V, Bushby K, Lochmuller H, Morris C. Muscle-Derived Proteins as Serum Biomarkers for Monitoring Disease Progression in Three Forms of Muscular Dystrophy. J Neuromuscul Dis. 2015 Sep 2;2(3):241-255. doi: 10.3233/JND-140066.
PubMed 26870665Carr, A. (2003). Adult Measures of Quality of Life: The Arthritis Impact Measurement Scales (AIMS/AIMS2), Disease Repercussion Profile (DRP), EuroQoL, Nottingham Health Profile (NHP), Patient Generated Index (PGI), Quality of Well-Being Scale (QWB), RAQoL, Short Form-36 (SF-36), Sickness Impact Profile (SIP), SIP-RA, and World Health Organization's Quality of Life Instruments (WHOQoL, WHOQoL-100, WHOQoL-Bref). Arthritis Care & Research, 49(S5), S113-S133. http://doi.org/10.1002/art.11414
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Equine-assisted Therapy for Adults and Older Adults With Arthritis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03141853
- Acronym / sponsor ID
- HEAT / 16-276
- Conditions
- Arthritis
- Keywords
- Randomized Controlled Trial, Intervention Study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of Missouri, Kansas CityUniversity, hospital or other
- Study start
- 20 May 2017 (actual)
- Primary completion
- 20 Dec 2017 (actual)
- Study completion
- 20 Dec 2017 (actual)
- First posted
- 5 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial. One group will receive equine-assisted therapy and the second group will receive arthritis exercise education
| Arm | Type | Receives |
|---|---|---|
| Equine-assisted Therapy Group | Experimental | Other: Equine-assisted TherapyThis 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. |
| Arthritis Exercise Education Group | Placebo comparator | Other: Arthritis Exercise EducationThis 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.). |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Equine-assisted TherapyAlso: Hippotherapy, Therapeutic Horseback RidingParticipants 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 | Equine-assisted Therapy Group |
| Arthritis Exercise EducationStandard 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 | Other | Arthritis Exercise Education Group |
Primary outcome
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.
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
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
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
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.
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
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
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
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.
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.
Missing Data - Missing data will be counted
Time frame: 8 Weeks
Missing data will be identified and counted.
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
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.
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.
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.
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.
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.
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.
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 secondary outcomes
Pain
Time frame: 0, 3, and 6 Weeks
Range of Motion
Time frame: 0, 3, and 6 Weeks
Serum Troponin
Time frame: 0 and 6 Weeks
Cartilage Oligomeric Matrix Protein (COMP) Biomarker
Time frame: 0 and 6 Weeks
Quality of Life
Time frame: 0, 3, and 6 Weeks
Enjoyment of Nature
Time frame: 0, 3, and 6 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2018.
- Background: PubMed 24425454Aranda-Garcia S, Iricibar A, Planas A, Prat-Subiran JA, Angulo-Barroso RM. Comparative effects of horse exercise versus traditional exercise programs on gait, muscle strength, and body balance in healthy older adults. J Aging Phys Act. 2015 Jan;23(1):78-89. doi: 10.1123/japa.2012-0326. Epub 2014 Jan 14.
- Background: PubMed 22002189Araujo TB, Silva NA, Costa JN, Pereira MM, Safons MP. Effect of equine-assisted therapy on the postural balance of the elderly. Rev Bras Fisioter. 2011 Sep-Oct;15(5):414-9. doi: 10.1590/s1413-35552011005000027. Epub 2011 Oct 14. English, Portuguese.
- Background: PubMed 26116374Barten DJ, Swinkels LC, Dorsman SA, Dekker J, Veenhof C, de Bakker DH. Treatment of hip/knee osteoarthritis in Dutch general practice and physical therapy practice: an observational study. BMC Fam Pract. 2015 Jun 27;16:75. doi: 10.1186/s12875-015-0295-9.
- Background: PubMed 23531491Beil K, Hanes D. The influence of urban natural and built environments on physiological and psychological measures of stress--a pilot study. Int J Environ Res Public Health. 2013 Mar 26;10(4):1250-67. doi: 10.3390/ijerph10041250.
- Background: PubMed 23841970Beinotti F, Christofoletti G, Correia N, Borges G. Effects of horseback riding therapy on quality of life in patients post stroke. Top Stroke Rehabil. 2013 May-Jun;20(3):226-32. doi: 10.1310/tsr2003-226.
- Background: PubMed 21243251Beinotti F, Correia N, Christofoletti G, Borges G. Use of hippotherapy in gait training for hemiparetic post-stroke. Arq Neuropsiquiatr. 2010 Dec;68(6):908-13. doi: 10.1590/s0004-282x2010000600015.
- Background: PubMed 21684382Bijlsma JW, Berenbaum F, Lafeber FP. Osteoarthritis: an update with relevance for clinical practice. Lancet. 2011 Jun 18;377(9783):2115-26. doi: 10.1016/S0140-6736(11)60243-2.
- Background: PubMed 12739908Bizub AL, Joy A, Davidson L. "It's like being in another world": demonstrating the benefits of therapeutic horseback riding for individuals with psychiatric disability. Psychiatr Rehabil J. 2003 Spring;26(4):377-84. doi: 10.2975/26.2003.377.384.
- Background: PubMed 18467932Boonstra AM, Schiphorst Preuper HR, Reneman MF, Posthumus JB, Stewart RE. Reliability and validity of the visual analogue scale for disability in patients with chronic musculoskeletal pain. Int J Rehabil Res. 2008 Jun;31(2):165-9. doi: 10.1097/MRR.0b013e3282fc0f93.
- Background: PubMed 21988646Borioni N, Marinaro P, Celestini S, Del Sole F, Magro R, Zoppi D, Mattei F, Dall' Armi V, Mazzarella F, Cesario A, Bonassi S. Effect of equestrian therapy and onotherapy in physical and psycho-social performances of adults with intellectual disability: a preliminary study of evaluation tools based on the ICF classification. Disabil Rehabil. 2012;34(4):279-87. doi: 10.3109/09638288.2011.605919. Epub 2011 Oct 12.
- BackgroundBoswell, S., Gusowski, K., Kaiser, A., & Flachenecker, P. (2009). Hippotherapy in multiple sclerosis - results of a prospective, controlled, randomised and single-blind trial. Poster presentation.
- BackgroundBrock, B.J, (1988). Effect of therapeutic horseback riding on physically disabled adults
- Arthritis Impact Measurement Scale 2Link provided by the sponsor.
- Range of Joint Motion Evaluation ChartLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cynthia L Russell, PhD study chair
University of Missouri, Kansas City
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Equine-assisted Therapy and Arthritis Exercise Education in people with Arthritis, run by University of Missouri, Kansas City at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attendance - Measured by number of participants attending each arm of the study (time frame: 0, 1, 2, 3, 4, 5, and week 6). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03141853, which also lists 63 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2018.