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Trial record 6 of 314 for:    Recruiting, Not yet recruiting, Available Studies | "Spinal Cord Injuries"

Kayak Ergometer Training in Individuals With Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT03531164
Recruitment Status : Recruiting
First Posted : May 21, 2018
Last Update Posted : May 21, 2018
Sponsor:
Collaborator:
Comisión Nacional de Investigación Científica y Tecnológica
Information provided by (Responsible Party):
Jimena Quinzaños, Instituto Nacional de Rehabilitacion

Brief Summary:

One of the main objectives in spinal cord injury rehabilitation programs is the improvement of trunk control in order to achieve independence, to prevent complications and, in specific cases to walk.

Research question: What is the effect of kayak ergometer training in trunk control, cardiovascular condition and independence in individuals with a spinal cord injury? Purpose: To determine the effect of kayak ergometer training in trunk control, cardiovascular condition and independence in individuals with a spinal cord injury.

Methods: Randomized clinical trial, blinded to evaluator and to the person that will analyze data.

Population: Spinal cord injured individuals treated at the National Institute of Rehabilitation, with a spinal cord injury of any ethiology, with a neurologic level of C8 and below, with time since injury from three months to one year.

Proceeding: The subjects will be randomly assigned to : a control group with neuro propioceptive facilitation exercises focused in trunk control or an experimental group with kayak ergometer training. Both groups will recieve 5 sessions a week during 6 weeks.


Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Other: kAYAK ERGOMETER GROUP Other: CONTROL GROUP Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Kayak Ergometer Training in Trunk Control, Independence and Cardiovascular Health in Individuals With Spinal Cord Injury
Actual Study Start Date : April 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Kayak ergometer group
Intervention: Training in kayak ergometer: 3 minutes of warming (pre-charge) , 3-5 intervals of training with moderate to high intensity and pauses of 2-4 minutes (charge) and 2 minutes of cooling down (post-charge) to complete 30 minutes.
Other: kAYAK ERGOMETER GROUP
Kayak ergometer training for 30 min 5 times a week for 6 weeks. The training includes a warming (pre charge) during 3 minutes, a training (charge) characterised by 3-5 intervals with medium to high intensity during 2-4 minutes and pauses of 1-2 minutes between active phases and 2 minutes of cooling down (post charge) to complete 30 minutes of training.

Active Comparator: Control group
Intervention: 30 minutes of proprioceptive neurofacilitation focused on trunk control
Other: CONTROL GROUP
Proprioceptive neurofacilitation exercises focused in trunk control during 30 minutes 5 times a week for 6 weeks.




Primary Outcome Measures :
  1. Trunk control [ Time Frame: 6 weeks ]
    Score between 0-24 The clinical trunk control test for individuals with spinal cord injury will be used


Secondary Outcome Measures :
  1. Spinal Cord Injury Independence Measure III [ Time Frame: Before training ]
    Validated specific independence measure for spinal cord injury. The main domains will be contemplated as secondary outcomes (Catz A, Spinal Cord 2007)

  2. Spinal Cord Injury Independence Measure III [ Time Frame: 6 weeks ]
    Validated specific independence measure for spinal cord injury. The main domains will be contemplated as secondary outcomes (Catz A, Spinal Cord 2007)

  3. Cardiac frequency [ Time Frame: Before training ]
    Registered with a polar

  4. Cardiac frequency [ Time Frame: 6 weeks ]
    Registered with a polar

  5. Arterial tension [ Time Frame: Before training ]
    Registered with a sphygmomanometer

  6. Arterial tension [ Time Frame: 6 weeks ]
    Registered with a sphygmomanometer

  7. Satisfaction with life [ Time Frame: Before training ]
    Life satisfaction questionnaire-9

  8. Satisfaction with life [ Time Frame: 6 weeks ]
    Life satisfaction questionnaire-9

  9. Metabolic Equivalent of Task [ Time Frame: Before training ]
    Exercise tolerance test

  10. Metabolic Equivalent of Task [ Time Frame: 6 weeks ]
    Exercise tolerance test

  11. Oxygen consumption [ Time Frame: Before training ]
    Exercise tolerance test

  12. Oxygen consumption [ Time Frame: 6 weeks ]
    Exercise tolerance test



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of spinal cord injury with any American Spinal Injury Association Impairment Scale (AIS) classification
  • Neurologic level below C8
  • Time since injury form 3 to 12 months
  • Any aetiology

Exclusion Criteria:

  • Another neurologic diagnosis
  • Sense organ alteration
  • Orthopaedic problem that interferes with training
  • Alteration in superior mental function
  • Cardiovascular or metabolic disease that interferes with trainig

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03531164


Contacts
Contact: Jimena Quinzaños, MD, MSc +525559991000 ext 13410 jquinzanos@inr.gob.mx
Contact: Ivett Quiñones, PhD

Locations
Mexico
Instituto Nacional de Rehabilitacion Recruiting
Mexico City, Mexico
Contact: Jimena Quinzaños, MD MSc    01525559991000 ext 13410    jimenaqf@hotmail.com   
Contact: Ivett Quiñones, PhD    01525559991000 ext 19606    iquinonesu@yahoo.com.mx   
Principal Investigator: Jimena Quinzaños, MSc         
Sub-Investigator: Ivett Quiñones, PhD         
Sub-Investigator: Cynthia Calderon, MD         
Sub-Investigator: Veronica Enriquez, PT         
Sub-Investigator: Isaac Perez-Sanpablo, MSc         
Sub-Investigator: Ramiro Perez, MD         
Sub-Investigator: Ana Aguirre, MD         
Sub-Investigator: Aida Barrera, MD         
Sponsors and Collaborators
Instituto Nacional de Rehabilitacion
Comisión Nacional de Investigación Científica y Tecnológica
Investigators
Principal Investigator: JImena Quinzaños, MD, MSc Instituto Nacional de Rehabilitacion

Responsible Party: Jimena Quinzaños, MD, MSc, Instituto Nacional de Rehabilitacion
ClinicalTrials.gov Identifier: NCT03531164     History of Changes
Other Study ID Numbers: 74/15
First Posted: May 21, 2018    Key Record Dates
Last Update Posted: May 21, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Jimena Quinzaños, Instituto Nacional de Rehabilitacion:
spinal cord injuries
kayak
trunk control

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System