Clinical trial NCT05068050: Multicenter, Randomized Trial to Determine the Effect of Therapeutic Riding, on a Group of People With Arthritis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthritis
Keywords: Therapeutic riding
Horse-assisted therapy
Arthritis treatments
Therapeutic exercise
Inertial Measurement Unit
Gait analysis
Sleep analysis
Pain analysis
Joints analysis
Lead sponsor: Universidad de Extremadura
Sponsor class: OTHER
Collaborators: name: University of Évora
name: University of Oviedo
name: AINISE - Alianza Internacional por la Interacción Saludable con Equinos
name: Universidad Rey Juan Carlos
name: University of Burgos
name: National University of Rosario
First posted: 2021-10-05
Enrollment: 20
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups of participants: i) experimental group, ii) active control group
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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%

Exclusion Criteria:

* 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).
* 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-

Primary outcomes:
measure: Pain in the main joints including at least back, waist, knees and shoulders
timeFrame: Change from baseline at Week 4 and Week 8
Secondary outcomes:
measure: Joint mobility: back, waist, knees and shoulders
timeFrame: Change from baseline at Week 4 and Week 8
measure: Dynamic balance
timeFrame: Change from baseline at Week 4 and Week 8
measure: Static balance
timeFrame: Change from baseline at Week 4 and Week 8
measure: Gait
timeFrame: Change from baseline at Week 4 and Week 8
measure: Exercise capacity
timeFrame: Change from baseline at Week 4 and Week 8
measure: Sleep quality
timeFrame: Each day from Week 1 at Week 8
measure: Sleep quality
timeFrame: Change from baseline at Week 8
Other outcomes:
Locations:
city: Badajoz
country: Spain
facility: María D Apolo Arenas
Study officials:
affiliation: HCU of Vigo
name: Íñigo Hernández Rodríguez, Phd
role: STUDY_DIRECTOR
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