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

NCT05068050 | Completed

• 1 other identifier: UdeExtremadura-2021-1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Arthritis

Keywords

Therapeutic riding; Horse-assisted therapy; Arthritis treatments; Therapeutic exercise; Inertial Measurement Unit; Gait analysis; Sleep analysis; Pain analysis; Joints analysis

Outcome Measures

Primary Outcomes (1)

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

  Analogic visual scale McGill Pain Quetionnaire Functional Pain tests

  Change from baseline at Week 4 and Week 8

Secondary Outcomes (7)

• Joint mobility: back, waist, knees and shoulders

  Change from baseline at Week 4 and Week 8

• Dynamic balance

  Change from baseline at Week 4 and Week 8

• Static balance

  Change from baseline at Week 4 and Week 8

• Gait

  Change from baseline at Week 4 and Week 8

• Exercise capacity

  Change from baseline at Week 4 and Week 8

Study Arms (2)

Experimental group

EXPERIMENTAL

This arm will be provided by horse-assisted therapy interventions.

Procedure: Horse-assisted therapy

Control group

ACTIVE COMPARATOR

This arm will be provided by the physical exercise interventions.

Procedure: Physical exercise

Interventions

Horse-assisted therapy PROCEDURE

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.

Experimental group

Physical exercise PROCEDURE

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

Control group

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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
• 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).

Sponsors & Collaborators

• Universidad de Extremadura: lead
• University of Évora: collaborator
• University of Oviedo: collaborator
• AINISE - Alianza Internacional por la Interacción Saludable con Equinos: collaborator
• Universidad Rey Juan Carlos: collaborator
• University of Burgos: collaborator
• National University of Rosario: collaborator

Study Sites (1)

María D Apolo Arenas

Badajoz, 06006, Spain

Location

Related Publications (15)

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• 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

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• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 29626616 BACKGROUND

• 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.

  BACKGROUND

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• 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

  BACKGROUND

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• 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.

  PMID: 28252520 BACKGROUND

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  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 30055598 BACKGROUND

MeSH Terms

Conditions

Arthritis

Interventions

Exercise

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Íñigo Hernández Rodríguez, Phd

  HCU of Vigo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants do not know the direction of the hypotheses The assessors are blinded to the assignment of the participants to the experimental group or the control group. The investigators treating the data are blinded to the allocation of participants to the experimental group or the control group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Two groups of participants: i) experimental group, ii) active control group

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: October 5, 2021
• Study Start: September 15, 2021
• Primary Completion: February 15, 2022
• Study Completion: May 15, 2022
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)