Kayak Ergometer Training in Individuals With Spinal Cord Injury
Primary Purpose
Spinal Cord Injuries
Status
Recruiting
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
kAYAK ERGOMETER GROUP
CONTROL GROUP
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injuries focused on measuring spinal cord injuries, kayak, trunk control
Eligibility 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
Sites / Locations
- Instituto Nacional de RehabilitacionRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Kayak ergometer group
Control group
Arm Description
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.
Intervention: 30 minutes of proprioceptive neurofacilitation focused on trunk control
Outcomes
Primary Outcome Measures
Trunk control
Score between 0-24, cut-off point 13. Higher values represent better results. The clinical trunk control test for individuals with spinal cord injury will be used
Secondary Outcome Measures
Spinal Cord Injury Independence Measure III
Validated specific independence measure for spinal cord injury. The main domains will be contemplated as secondary outcomes (Catz A, Spinal Cord 2007). Score ranges between 0 and 100. Higher values represent better results.
Spinal Cord Injury Independence Measure III
Validated specific independence measure for spinal cord injury. The main domains will be contemplated as secondary outcomes (Catz A, Spinal Cord 2007). Score ranges between 0 and 100. Higher values represent better results.
Cardiac frequency
Registered with a polar
Cardiac frequency
Registered with a polar
Arterial tension
Registered with a sphygmomanometer
Arterial tension
Registered with a sphygmomanometer
Satisfaction with life
Life satisfaction questionnaire-9 is a validated questionnaire to assess life satisfaction in people with a spinal cord injury. It is composed of 9 questions that are rated by the patient between 1 (very dissatisfying) to 6 (very satisfying) and that explore perception in life as a hole, vocational, financial and leisure situations, contact with friends and acquaintances, sexual life and family life, partnership relation, physical and psychological health. Score ranges between 9 and 54. Higher values represent better results.
Satisfaction with life
Life satisfaction questionnaire-9 is a validated questionnaire to assess life satisfaction in people with a spinal cord injury. It is composed of 9 questions that are rated by the patient between 1 (very dissatisfying) to 6 (very satisfying) and that explore perception in life as a hole, vocational, financial and leisure situations, contact with friends and acquaintances, sexual life and family life, partnership relation, physical and psychological health. Score ranges between 9 and 54. Higher values represent better results.
Metabolic Equivalent of Task
Exercise tolerance test
Metabolic Equivalent of Task
Exercise tolerance test
Oxygen consumption
Exercise tolerance test
Oxygen consumption
Exercise tolerance test
Full Information
NCT ID
NCT03531164
First Posted
March 5, 2018
Last Updated
January 3, 2023
Sponsor
Instituto Nacional de Rehabilitacion
Collaborators
Comisión Nacional de Investigación Científica y Tecnológica
1. Study Identification
Unique Protocol Identification Number
NCT03531164
Brief Title
Kayak Ergometer Training in Individuals With Spinal Cord Injury
Official Title
Effect of Kayak Ergometer Training in Trunk Control, Independence and Cardiovascular Health in Individuals With Spinal Cord Injury
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 2016 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Nacional de Rehabilitacion
Collaborators
Comisión Nacional de Investigación Científica y Tecnológica
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Spinal Cord Injury (SCI) is an alteration of the spinal cord that modifies not only muscular strength and sensitivity, but that also generates a change in all of the systems of the organism. At the worldwide level, an incidence is calculated of between 13.1 and 52.2 per one million inhabitants.
Damage to the ascending and descending tracts of the spinal cord consequently gives rise to an alteration in the postural control system. It is known that effective postural control is of utmost importance forstanding and walking, as well as for providing support for voluntary movements. Alterations in posture depend on the grade and level of the injury; thus, persons with complete, thoracic, or cervical lesions have poor trunk control. Due to the latter, they are limited in many of the movements necessary for carrying out daily life activities (DALYS) Therefore, part of the objectives of rehabilitation in individuals with an SCI comprises improvement in trunk control.
On the other hand, patients with SCI tend to engage in a sedentary lifestyle that, added to the alterations in the autonomic nervous system proper to the lesion, exposes individuals with a SCI to a greater risk of developing chronic-degenerative conditions, such as metabolic syndrome and cardiovascular diseases, which are, at present, the main cause of death in these persons.
Thus, after the immediate rehabilitation, it is necessary to maintain and improve the functional capacity obtained during this process. Therefore, it is important to find training activities to challenge stabilization of the upper part of the body and sitting equilibrium without giving rise to symptoms caused by overuse.
Kayak training appears to comply with these criteria, in that it implicates the greater part of the upper musculature, presents high metabolic demands, and imposes strict requirements for the balance control system, due to continuous compensation of the disturbances of the upper part of the body caused by movement on the apparatus. It was previously demonstrated that open-sea training in kayaks could be implemented in a group of individuals in paraplegic condition and that this is accompanied by improvements in strength and equilibrium in sedestatIon.
Due to the difficulty in controlling and adjusting the time and challenge level of the equilibrium experienced by participants at sub-acute stages, it is necessary to utilize a kayak ergometer, in such a way that the demand for equilibrium can be adjusted individually and for this to increase progressively as the treatment advances. In this respect, Bjerkefors and Thorstensson demonstrated that kayak ergometer training in a group of persons with SCI is accompanied by improvement in shoulder muscular strength and in various functional wheelchair tests that demand trunk stabilization and balance control.
These studies achieved demonstrating the positive effect of kayak training in patients with SCI; however, in these studies, small populations were included (10 and 12 individuals), with chronic-stage lesions, and the effects on trunk control were not evaluated by means of a validated scale in this population, nor were the training's effects on cardiovascular function and functional independence.
To date, the effect of kayak ergometer training has not, to our knowledge, been studied in individuals with SCI in terms of trunk control with tools validated for persons with SCI, regarding the cardiovascular condition, functional independence, and quality of life, thus engendering the need to conduct this present study.
HYPOTHESIS
Kayak ergometer training will improve functional independence, trunk control, and cardiovascular condition in individuals with SCI.
The effect of training with the kayak ergometer on functional independence, trunk control, and the cardiovascular condition in individuals with SCI will be greater than that of conventional trunk-control training.
GENERAL OBJECTIVE
To determine the effect of kayak ergometer training in patients with SCI in functionality, trunk control, cardiovascular condition, and quality of life.
SPECIFIC OBJECTIVES
Establish the validity, reliability, error, and sensitivity of the measurement instrumented of trunk control in subjects with SCI.
Evaluate the existence of floor/ceiling effects in the instrumented assessment of trunk control.
Develop computerized tools for evaluation of trunk control that are easily applicable in daily clinical practice, with low-cost, practical, and simple technology for improving the exactness and reliability of the observational analysis, for rehabilitation centers that are not equipped with a movement-analysis laboratory, with sufficient information for evaluating the trunk control of the individual with SCI.
Proposal of a pilot program of trunk control rehabilitation in persons with SCI.
Broadcast preliminary results at a national scientific meeting.
Form human resources with knowledge of neurological rehabilitation, movement analysis, and biomedical engineering.
Foster multidisciplinary cooperation.
MATERIALS AND METHODS
Study type. Randomized controlled clinical trial blinded to the evaluator and to the person performing the data analysis.
Description of the work universe. Patients of out-patient consultations and hospitalization of the SCI Service of the National Institute of Rehabilitation), with a diagnosis of SCI of any etiology, with a neurological level of under C8, with a SCI of 3 months of evolution.
Definition of the control group Group A. Control group, management with conventional therapy for improvement of trunk control (proprioceptive neurofacilitation exercises focused on trunk control21) of 20 minutes five times weekly during 6 weeks.
Sample size We utilized the Epidat ver. 4 statistical software program to calculate sample size. For 80% study power and an alpha error probability of less than 0.05, and considering the work of Grigorenko and collaborators18 we found a frontal displacement speed difference of the Center of Pressure (CoP) of 0.1m/s with a Standard Deviation (SD) of 0.05 m/s between the experimental and the control group. Therefore, seven patients per group were required. Considering a possible loss of 20%, we will recruit nine patients per group.
Description of the study variables, units of measure, and measuring scales
Clinical and demographic variables
SCI severity: According to American Spinal Injury Association, with International standards for neurological classification of spinal cord injury modifications: complete, B: incomplete, preservation of only the sensitive function, C: incomplete, voluntary anal contraction or more than half of key muscles in <3, D: incomplete, more than half of the key muscles in >3, E: total recuperation A, B, C, D, E
Neurological level: More caudal segment of the SC with normal function
Time of evolution of the SCI:Time in days elapsed from when the SCI was produced until time of application of the questionnaire
Age:Years elapsed from date of birth to time of questionnaire application
Proposed statistical analysis
The investigators will utilize the Statistical Package for the Social Sciences ver. 17 statistical software program. The investigators will perform descriptive statistics with central-tendency measurements for quantitative variables and with proportions for qualitative variables. To determine differences between groups, analysis of covariance will be carried out. Results that are statistically significant with a p of <0.05 will be considered.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
spinal cord injuries, kayak, trunk control
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Kayak ergometer group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Intervention: 30 minutes of proprioceptive neurofacilitation focused on trunk control
Intervention Type
Other
Intervention Name(s)
kAYAK ERGOMETER GROUP
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
CONTROL GROUP
Intervention Description
Proprioceptive neurofacilitation exercises focused in trunk control during 30 minutes 5 times a week for 6 weeks.
Primary Outcome Measure Information:
Title
Trunk control
Description
Score between 0-24, cut-off point 13. Higher values represent better results. The clinical trunk control test for individuals with spinal cord injury will be used
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Spinal Cord Injury Independence Measure III
Description
Validated specific independence measure for spinal cord injury. The main domains will be contemplated as secondary outcomes (Catz A, Spinal Cord 2007). Score ranges between 0 and 100. Higher values represent better results.
Time Frame
Before training
Title
Spinal Cord Injury Independence Measure III
Description
Validated specific independence measure for spinal cord injury. The main domains will be contemplated as secondary outcomes (Catz A, Spinal Cord 2007). Score ranges between 0 and 100. Higher values represent better results.
Time Frame
6 weeks
Title
Cardiac frequency
Description
Registered with a polar
Time Frame
Before training
Title
Cardiac frequency
Description
Registered with a polar
Time Frame
6 weeks
Title
Arterial tension
Description
Registered with a sphygmomanometer
Time Frame
Before training
Title
Arterial tension
Description
Registered with a sphygmomanometer
Time Frame
6 weeks
Title
Satisfaction with life
Description
Life satisfaction questionnaire-9 is a validated questionnaire to assess life satisfaction in people with a spinal cord injury. It is composed of 9 questions that are rated by the patient between 1 (very dissatisfying) to 6 (very satisfying) and that explore perception in life as a hole, vocational, financial and leisure situations, contact with friends and acquaintances, sexual life and family life, partnership relation, physical and psychological health. Score ranges between 9 and 54. Higher values represent better results.
Time Frame
Before training
Title
Satisfaction with life
Description
Life satisfaction questionnaire-9 is a validated questionnaire to assess life satisfaction in people with a spinal cord injury. It is composed of 9 questions that are rated by the patient between 1 (very dissatisfying) to 6 (very satisfying) and that explore perception in life as a hole, vocational, financial and leisure situations, contact with friends and acquaintances, sexual life and family life, partnership relation, physical and psychological health. Score ranges between 9 and 54. Higher values represent better results.
Time Frame
6 weeks
Title
Metabolic Equivalent of Task
Description
Exercise tolerance test
Time Frame
Before training
Title
Metabolic Equivalent of Task
Description
Exercise tolerance test
Time Frame
6 weeks
Title
Oxygen consumption
Description
Exercise tolerance test
Time Frame
Before training
Title
Oxygen consumption
Description
Exercise tolerance test
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jimena Quinzaños, MD, MSc
Phone
+525559991000
Ext
13410
Email
jquinzanos@inr.gob.mx
First Name & Middle Initial & Last Name or Official Title & Degree
Ivett Quiñones, PhD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JImena Quinzaños, MD, MSc
Organizational Affiliation
Instituto Nacional de Rehabilitacion
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Nacional de Rehabilitacion
City
Mexico City
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jimena Quinzaños, MD MSc
Phone
01525559991000
Ext
13410
Email
jimenaqf@hotmail.com
First Name & Middle Initial & Last Name & Degree
Ivett Quiñones, PhD
Phone
01525559991000
Ext
19606
Email
iquinonesu@yahoo.com.mx
First Name & Middle Initial & Last Name & Degree
Jimena Quinzaños, MSc
First Name & Middle Initial & Last Name & Degree
Ivett Quiñones, PhD
First Name & Middle Initial & Last Name & Degree
Cynthia Calderon, MD
First Name & Middle Initial & Last Name & Degree
Veronica Enriquez, PT
First Name & Middle Initial & Last Name & Degree
Isaac Perez-Sanpablo, MSc
First Name & Middle Initial & Last Name & Degree
Ramiro Perez, MD
First Name & Middle Initial & Last Name & Degree
Ana Aguirre, MD
First Name & Middle Initial & Last Name & Degree
Aida Barrera, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data base whithout identificatiopns
IPD Sharing Time Frame
After january 2022 for 5 years
IPD Sharing Access Criteria
Ask the authors directly by mail
Learn more about this trial
Kayak Ergometer Training in Individuals With Spinal Cord Injury
We'll reach out to this number within 24 hrs