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

May 9, 2023 updated by: Mª Dolores Apolo Arenas, Universidad de Extremadura

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Badajoz, Spain, 06006
        • María D Apolo Arenas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
This arm will be provided by horse-assisted therapy interventions.
Procedure: Horse-assisted therapy

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.
Active Comparator: Control group
This arm will be provided by the physical exercise interventions.
Procedure: Physical exercise

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain in the main joints including at least back, waist, knees and shoulders
Time Frame: Change from baseline at Week 4 and Week 8
Analogic visual scale McGill Pain Quetionnaire Functional Pain tests
Change from baseline at Week 4 and Week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Joint mobility: back, waist, knees and shoulders
Time Frame: Change from baseline at Week 4 and Week 8
Joint goniometry. Digital goniometer
Change from baseline at Week 4 and Week 8
Dynamic balance
Time Frame: Change from baseline at Week 4 and Week 8
Berg balance test
Change from baseline at Week 4 and Week 8
Static balance
Time Frame: Change from baseline at Week 4 and Week 8
Romberg balance test on pressure platform. To stay standing up during 30 seconds, without moving, eyes open and closed.
Change from baseline at Week 4 and Week 8
Gait
Time Frame: Change from baseline at Week 4 and Week 8
10 Meters moving test. Assesment by intertial sensors placed in Head, L3, Hip, Tibia and Arms
Change from baseline at Week 4 and Week 8
Exercise capacity
Time Frame: Change from baseline at Week 4 and Week 8
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)
Change from baseline at Week 4 and Week 8
Sleep quality
Time Frame: Each day from Week 1 at Week 8
Measurements of the sleeping quality based on the times of the different phases with the tool TicSleep from MOVOI (Smartwatch data collection system)
Each day from Week 1 at Week 8
Sleep quality
Time Frame: Change from baseline at Week 8
PittsBurg sleeping quality test
Change from baseline at Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Extremadura

Collaborators

University of Oviedo
Universidad Rey Juan Carlos
University of Évora
AINISE - Alianza Internacional por la Interacción Saludable con Equinos
University of Burgos
National University of Rosario

Investigators

  • Study Director: Íñigo Hernández Rodríguez, Phd, HCU of Vigo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2021

Primary Completion (Actual)

February 15, 2022

Study Completion (Actual)

May 15, 2022

Study Registration Dates

First Submitted

September 15, 2021

First Submitted That Met QC Criteria

September 26, 2021

First Posted (Actual)

October 5, 2021

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 9, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UdeExtremadura-2021-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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