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ArthritisARTHERNCT05068050

Multicenter, Randomized Trial to Determine the Effect of Therapeutic Riding, on a Group of People With Arthritis

A study testing Horse-assisted therapy and Physical exercise in people with Arthritis, run by Universidad de Extremadura at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this job is to evaluate the possible changes in the state of health of 10 indi-viduals diagnosed with arthritis who follow a standardised Therapeutic Riding treatment, as an experimental group, versus 10 patients who follow a standardised physical exercise programme. Read more about this study

Who is it for?
Ages 25 to 65 years
Conditions the study is for
Arthritis
What is being tested?
Horse-assisted therapy and Physical exercise
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteSpain
Study dates
15 Sep 2021to 15 May 2022
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 25 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients diagnosed with arthritis.
  • Age over 25 and under 65.
  • Not riding on horseback in the last 6 months.
  • Enough physical autonomy to be able to ride independently.
  • Having pain in a joint with mild to moderate pain and / or decreased range of motion in any joint of a minimum of 10%

Who cannot join

  • Age under 25 and over 65.
  • Having ridden on horseback in the previous 6 months.
  • NOT having sufficient physical autonomy to be able to ride independently.
  • DO NOT have pain in any joint with mild to moderate pain and / or
  • DO NOT have a decrease in the range of motion in any joint of a minimum of 10% Have some other associated neuromuscular disease.
  • Pregnancy
Show all 43Show fewer
  • Contraindications of the E.T.: The German Commissariat for Therapeutic Riding Deutsches Kuratorium Für Therpeutisches Reiten (DKThR) endorse by more than 40 years of research, training and practice of said contraindications in relative and absolute terms, being:
  • Relative contraindications:
  • Relative contraindications: It depends on each person. To value. The current relative contraindications always require a detailed consultation with the treating specialist and weighing the risks in Relationship with the expected success of the treatment.
  • Hip displacement (the degree must be known).
  • Metal implants in the extremities.
  • Disc operations (must have passed more than 1 year).
  • Degenerative immobilization of the spine (depends on the location).
  • Scoliosis Cobb angle> 25º (outside the central straight line).
  • M.Bechterew (depends on immobility and pain).
  • Osteoporosis (dig with Cortisone and inactivity).
  • Hematolytics (Marcumar).
  • disturbed blood clotting.
  • Spondylolisthesis.
  • Epilepsy (the patient would have to spend a year without seizures; you have to think about the type of seizure, the triggering cause, the patient's age and weight).
  • Diabetes mellitus (consider age, intensity and coexistence with diabetes). • Rhythmic cardiac disorders.
  • Heart failure.
  • Heart attack (it must be more than a year since the heart attack).
  • Extreme trophic and sensitivity disorders.
  • Age (depending on size and evolution, from 4 years to almost 65).
  • Obesity (depends on the horses available, and the severity of the limitation of movement).
  • Lack of trunk control.
  • Seriously disturbed behavior (aggressive patients, with loud voices, etc.). • Periarticular ossifications.
  • Bladder catheter.
  • Sharp pains.
  • Endoprosthesis (knee, hip).
  • Absolute contraindications:
  • Acute inflammatory processes.
  • Acute herniated disc prolapse.
  • Allergies (dust, horse hair).
  • Insurmountable adductor spasticity.
  • Coxarthrodesis.
  • Acute rheumatism.
  • Thrombosis, thrombophlebitis.
  • Arterial hypertonia with a tendency to hypertensive crisis.
  • Angina pectoris, strong arteriosclerosis.
  • Spondylodesis (exception: stable angular spondylodesis in spinal cord injuries, in these usually only one segment stabilizes, talk to the doctor).
  • Implants of the trunk, pelvis and femur-

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • María D Apolo Arenas

    Badajoz, 06006

Other trials in Spain

About this study

Official title: Clinical, Data Collection, Multicenter, Randomized Trial to Determine the Effect of Therapeutic Riding Compared With Physical Activity on a Group of People With Arthritis

The aim of this job is to evaluate the possible changes in the state of health of 10 indi-viduals diagnosed with arthritis who follow a standardised Therapeutic Riding treatment, as an experimental group, versus 10 patients who follow a standardised physical exercise programme.

The intervention guidelines for both groups are established in a programme of 12 ses-sions in total, 6 weeks in duration, twice a week and a duration of 45 minutes each ses-sion.

The effectiveness of the intervention program will be evaluated in terms of pain, joint mobility, static and dynamic balance, gait, capacity for effort and quality of sleep.

Read the detailed description

Arthritis is inflammation of the joints, causing pain, stiffness and limitations in activities of daily living, with decreased quality of life.

To improve musculoskeletal and functional health, the World Health Organization recommends physical activity, including aerobic physical activity, to improve strength, flexibility and balance. Non-pharmacological recommendations include physical conditioning, which can be provided through Therapeutic Riding. Advances and research in the area of Equine Assisted Interventions (Hippotherapy and Therapeutic Riding) have led to a progressive move away from empirical observation to scientific evidence. This is why it is necessary to develop scientific studies that contribute to scientific evidence. This has motivated an international group of experts to design and develop an international clinical trial to collect data on therapeutic horse riding in a group of adults with arthritis. Starting with a pilot project, which is the one presented here.

The established hypothesis is that people diagnosed with arthritis who follow a standardised Therapeutic Riding treatment, as an experimental group, improve their state of health in relation to those who follow a protocolised physical exercise table.

Main objectives: To evaluate the possible changes in the state of health of individuals diagnosed with arthritis who follow a standardised Therapeutic Riding treatment, as an experimental group, versus patients who follow a standardised physical exercise programme and to analyse the effectiveness of the Therapeutic Riding treatment in patients diagnosed with arthritis in terms of pain, joint mobility, static and dynamic balance, gait, capacity for effort and quality of sleep. Furthermore, the aim is to monitor and establish the methodology, protocols and phases in the Therapeutic Riding treatment of patients with a diagnosis of arthritis, as well as to contribute to assessment protocols.

Methodology: In order to achieve the objectives, a double-blind randomised pilot project is proposed in a sample of 10 subjects participating in a therapeutic horse riding programme and 10 subjects participating as a control group in a physical exercise programme. The intervention guidelines for both groups are established in a programme of 12 sessions in total, 6 weeks in duration, twice a week and a duration of 45 minutes each session. All interventions will be carried out by specialist professionals. Pain will be assessed using the EVA scale and questionnaires; joint range in the back, hips, knees and shoulders using goniometry; postural stability using the Romberg test on pressure platforms; gait analysis using inertial sensors during the 10-metre test; capacity for effort using the 2-minute walk test and the use of a smartwatch; and sleep quality using the PittsBurg sleep quality test and MOVOI's TicSleep tool. All assessments are non-invasive.

The project is coordinated by AINISE (International Alliance for Healthy Equine Interaction) and involves an international scientific group led by Dr Íñigo Hernández. It is made up of volunteer expert researchers from 8 countries. Germany, Argentina, Spain, France, Malta, Mexico, Portugal, USA, in which the research group Physioh of the University of Extremadura participates. The project is based on the published trial of Dr. Sharon White Lewis University of Missouri-Kansas City. "A Randomized controlled trial comparing equine-assisted therapy and exercise education for adults and older adults with arthritis". And it is currently supported to start the pilot programme by the Norwegian Ann Kern-Godal Foundation.

Conditions
Arthritis
Being tested
Horse-assisted therapy, Physical exercise
Keywords
Therapeutic riding, Horse-assisted therapy, Arthritis treatments, Therapeutic exercise, Inertial Measurement Unit, Gait analysis, Sleep analysis, Pain analysis, Joints analysis
Medical subject headings
Arthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Horse-assisted therapyProcedure or surgery

    12 horse-assisted therapy sessions (45 mins each) for 6 weeks.

    Each session will comprise the next stages:

    Groundwork, Approachment and preparation of the horse, Warm up exercises

    Development of the main part (riding):

    Introduction - beginning: Breathing control and body awareness, maintain sitting (riding position) while walking on the horse, perceiving the movement Exercises for the postural and balance control: Variations in the walking of the horse, realize different figures in the arena (circles, serpentines, change direction…), Stopping and Walking, Arms situation combined with the movement of the horse All exercises are determined in the track design protocol Exercises for the acquisition of motion skills: Finished the riding with relaxation activities. Final part: Dismount the horse, Unsaddled and unbridle, feedback and goodbye procedure.

  • Physical exerciseProcedure or surgery

    12 physical exercise sessions (45 mins each) for 6 weeks. Each session Each session Lessons will be held by physical activity professionals. The proposed exercises are focussed on improving the articular movements, aerobic resistance and the proprioception, always on the premises of No Pain.

    Lessons will be divided in three parts :

    1. Warmup - 2. Main part - 3. Return to calm

    Lessons will be hold online

Study groups in NCT05068050
Study groupRoleWhat they receive
Experimental groupExperimentalThis arm will be provided by horse-assisted therapy interventions.
Receives: Procedure: Horse-assisted therapy
Control groupActive comparatorThis arm will be provided by the physical exercise interventions.
Receives: Procedure: Physical exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain in the main joints including at least back, waist, knees and shoulders

    Analogic visual scale McGill Pain Quetionnaire Functional Pain tests

    Measured: Change from baseline at Week 4 and Week 8

Secondary outcomes (7)

  1. Joint mobility: back, waist, knees and shoulders

    Joint goniometry. Digital goniometer

    Measured: Change from baseline at Week 4 and Week 8

  2. Dynamic balance

    Berg balance test

    Measured: Change from baseline at Week 4 and Week 8

  3. Static balance

    Romberg balance test on pressure platform. To stay standing up during 30 seconds, without moving, eyes open and closed.

    Measured: Change from baseline at Week 4 and Week 8

  4. Gait

    10 Meters moving test. Assesment by intertial sensors placed in Head, L3, Hip, Tibia and Arms

    Measured: Change from baseline at Week 4 and Week 8

  5. Exercise capacity

    Two minutes walk test on a 30 meter straight line. Measurement of daily activity with a smartwatch using a heart rate monitor and all watch sensors (subjects will keep watches on their wrist for the entire duration of study)

    Measured: Change from baseline at Week 4 and Week 8

  6. Sleep quality

    Measurements of the sleeping quality based on the times of the different phases with the tool TicSleep from MOVOI (Smartwatch data collection system)

    Measured: Each day from Week 1 at Week 8

  7. Sleep quality

    PittsBurg sleeping quality test

    Measured: Change from baseline at Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2021
  2. Study start15 Sep 2021
  3. Primary completion15 Feb 2022
  4. Study completion15 May 2022

Resources

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
Two groups of participants: i) experimental group, ii) active control group
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05068050
Sponsor's protocol ID
UdeExtremadura-2021-1
Acronym
ARTHER
Status last verified
May 2023
First submitted
15 Sep 2021
Last updated
10 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Araujo PA, Starling JMP, Oliveira VC, Gontijo APB, Mancini MC. Combining balance-training interventions with other active interventions may enhance effects on postural control in children and adolescents with cerebral palsy: a systematic review and meta-analysis. Braz J Phys Ther. 2020 Jul-Aug;24(4):295-305. doi: 10.1016/j.bjpt.2019.04.005. Epub 2019 May 3.

    PubMed 31076254

  • Caña-Pino, A., Apolo-Arenas, M. D., Moral-Blanco, J., Álvaro-de Diego, J., & Gutiérrez, C. F. (2015). Assessment by accelerometer of postural balance in standing-sitting position in healthy subjects-A pilot study. Fisioterapia, 37(6), 271-278. https://doi.org/10.1016/j.ft.2014.12.004

  • Charry-Sanchez JD, Pradilla I, Talero-Gutierrez C. Animal-assisted therapy in adults: A systematic review. Complement Ther Clin Pract. 2018 Aug;32:169-180. doi: 10.1016/j.ctcp.2018.06.011. Epub 2018 Jun 28.

    PubMed 30057046

  • Fernández-Gutiérrez, C., Apolo-Arenas, M. D., Martínez-García, Y., & Caña-Pino, A. (2015). Effects of hippotherapy on postural stability in cerebral palsy: report of a case. Fisioterapia, 37(3), 135-139.

  • Gutiérrez, C. F., Arenas, M. D. A., Moral-Blanco, J., Madrid-Moreno, M., & Pino, A. C. (2019). Valoración con acelerómetros del incremento en el control postural y equilibrio de una niña con parálisis cerebral que recibe hipoterapia. Cuestiones de fisioterapia: revista universitaria de información e investigación en Fisioterapia, 48(2), 127-132.

  • Hilliere C, Collado-Mateo D, Villafaina S, Duque-Fonseca P, Parraca JA. Benefits of Hippotherapy and Horse Riding Simulation Exercise on Healthy Older Adults: A Systematic Review. PM R. 2018 Oct;10(10):1062-1072. doi: 10.1016/j.pmrj.2018.03.019. Epub 2018 Apr 5.

    PubMed 29626616

  • Mamajón-Pámpano, L., López-Ortiz, L., Pino, A. C., Sánchez-Preciado, A. M., & Arenas, M. D. A. (2019). Study of the effect of sensory dynamic orthosis on postural control in a case of nemaline myopathy. Cuestiones de fisioterapia: revista universitaria de información e investigación en Fisioterapia, 48(3), 228-234.

  • Marquez J, Weerasekara I, Chambers L. Hippotherapy in adults with acquired brain injury: A systematic review. Physiother Theory Pract. 2020 Jul;36(7):779-790. doi: 10.1080/09593985.2018.1494233. Epub 2018 Jul 17.

    PubMed 30015542

  • Massy-Westropp, N. (2004). Measurement of hand joint range of motion in rheumatoid arthritis: Repeatability and variability. Journal of Hand Therapy, 17(4), 438. https://doi.org/10.1197/j.jht.2004.07.027

  • Schmidt J, Wartenberg-Demand A, Forstmeier S. Equine-assisted biographical work (EABW) with individuals in the second half of life: study protocol of a multicentre randomised controlled trial. Trials. 2020 Oct 15;21(1):857. doi: 10.1186/s13063-020-04784-3.

    PubMed 33059730

  • Stergiou A, Tzoufi M, Ntzani E, Varvarousis D, Beris A, Ploumis A. Therapeutic Effects of Horseback Riding Interventions: A Systematic Review and Meta-analysis. Am J Phys Med Rehabil. 2017 Oct;96(10):717-725. doi: 10.1097/PHM.0000000000000726.

    PubMed 28252520

  • Tseng SH, Chen HC, Tam KW. Systematic review and meta-analysis of the effect of equine assisted activities and therapies on gross motor outcome in children with cerebral palsy. Disabil Rehabil. 2013 Jan;35(2):89-99. doi: 10.3109/09638288.2012.687033. Epub 2012 May 26.

    PubMed 22630812

  • Villaverde, V., Hernández-García, C., Gonzalez-Alvaro, I., Vargas, E., Abasolo, L., Morado, I. C., & grupo de estudio emAR. (2005). Clinical evaluation of patients with rheumatoid arthritis in Spain. Rev Esp Reumatol, 32(3), 112-120. https://bit.ly/34Tc51z

  • White-Lewis, S. (2018). A Randomized Controlled Trial Comparing Equine-Assisted Therapy and Exercise Education for Adults and Older Adults with Arthritis. Doctoral dissertation, University of Missouri--Kansas City. https://bit.ly/2WOYKE5

  • Zhang L, Cao H, Zhang Q, Fu T, Yin R, Xia Y, Li L, Gu Z. Motion analysis of the wrist joints in Chinese rheumatoid arthritis patients: a cross-sectional study. BMC Musculoskelet Disord. 2018 Jul 28;19(1):270. doi: 10.1186/s12891-018-2146-z.

    PubMed 30055598

Questions about this trial

What is this clinical trial studying?

A study testing Horse-assisted therapy and Physical exercise in people with Arthritis, run by Universidad de Extremadura at 1 site in Spain.

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 43 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 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. 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. 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?

Pain in the main joints including at least back, waist, knees and shoulders (time frame: Change from baseline at Week 4 and Week 8). 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 NCT05068050, which also lists 15 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 10 May 2023.

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