Cardiovascular Health/Outcomes: Improvements Created by Exercise and Eduction in SCI (CHOICES)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of British Columbia
Sponsor:
Collaborators:
McMaster University
Toronto Rehabilitation Institute
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01718977
First received: October 24, 2012
Last updated: April 28, 2014
Last verified: April 2014
  Purpose

This study aims to determine whether body weight-supported treadmill training (BWSTT) has beneficial effects, over and above arm-cycle ergometry training (ACET) on indicators of cardiovascular disease (CVD) risk in individuals with severe spinal cord injury (SCI).

After SCI, the primary cause of illness and death is CVD. Currently, preventative measures focus around increasing physical activity- especially through the use of ACET. However, ACET's capacity to improve cardiovascular health is questionable. Research has demonstrated that BWSTT, an alternative form of exercise, may be capable of improving cardiovascular health in individuals with SCI.

The studies primary outcome measure is aortic pulse wave velocity (aPWV) which has been shown to have prognostic value for CVD above and beyond that of other risk factors. It is hypothesised that through large muscle mass involvement and postural challenge, the physical stimuli of BWSTT will reduce aPWV and lower CVD risk in individuals with SCI.


Condition Intervention
Spinal Cord Injury
Other: Body Weight Supported Treadmill Training
Other: Arm Cycle Ergometry Training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Cardiovascular Health/Outcomes: Improvements Created by Exercise and Eduction in SCI (CHOICES)

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • The effect of Body Weight Support Treadmill Training (BWSTT) on Aortic Pulse Wave Velocity (aPWV) in people with Spinal Cord Injury (SCI) at 3- and 6-months of exercise and 6-months post intervention. [ Time Frame: aPWV assessed at baseline, 3- and 6-months and 6 months post intervention. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The effect of Body Weight Support Treadmill Training (BWSTT) on Cardiovascular parameters in people with Spinal Cord Injury (SCI) at 3- and 6-months of exercise and 6-months post intervention. [ Time Frame: Assessed at baseline, 3- and 6-months and 6-months post intervention ] [ Designated as safety issue: No ]

    Assessments of Blood Pressure & Heart Rate, Arterial Structure, Cardiac Structure & Function, Orthostatic Instability(Sit-Up Test) and 48-hr Blood Pressure Lability will be used to assess cardiovascular function.

    Parameters recorded from these tests include End Systolic Volume, End Diastolic Volume, Intraventricular Septum Systole (IVSs), Intraventricular Septum Diastole (IVSd), Left Ventricular Internal Diameter Systole (LVIDs), Left Ventricular Posterior Wall Systole (LVIDd), Left Ventricular Posterior Wall Diastole (LVPWd), Ejection Fraction, Cardiac Output, Fractional Shortening, Mitral Regurgitation (dP/dT), E/A, E/e' ratio, IVRT, DT, Lumen Diameter, Intima-Media Thickness, Wall/Lumen Ratio (Carotid, Brachial & Femoral), Systolic Blood Pressure, Diastolic Blood Pressure, Mean Arterial Blood Pressure and Heart Rate.


  • The effect of 6-months Body Weight Support Treadmill Training (BWSTT) on Autonomic function in people with Spinal Cord Injury (SCI). Diastolic Blood Pressure Mean Arterial Blood Pressure Heart Rate [ Time Frame: Assessed at baseline and 6-months. ] [ Designated as safety issue: No ]
    This outcome measure is to be assessed using the International Autonomic Standards Evaluation.

  • The effect of Body Weight Support Treadmill Training (BWSTT) on Body Composition in people with Spinal Cord Injury (SCI) at 6-months of exercise and 6-months post intervention. [ Time Frame: Assessed at baseline, 6-months and 6-months post-intervention ] [ Designated as safety issue: No ]

    Body composition will be assessed using Dual Energy X-Ray Absorbitrometry (DXA).

    DXA will assess Weight, Height, BMI, Total Body Fat (Kg), Body Fat Percentage, Waist Circumference, Hip Circumference.


  • The effect of Body Weight Support Treadmill Training (BWSTT) on Metabolic parameters in people with Spinal Cord Injury (SCI) at 6-months of exercise and 6-months post intervention. [ Time Frame: Assessed at baseline, 6-months and 6-months post-intervention ] [ Designated as safety issue: No ]
    Metabolic parameters will be assessed through blood analysis. Blood analysis will yield the following mteabolic parameters: White Blood Cell Count, Erythrocytes, Packed Cell Volume, Hematocrit, Platelets, Hemoglobin, Red Cell Indices, HbA1C, Fasting Glucose, Fasting Insulin, Triglycerides, Total Cholesterol, LDL-c, HDL-c, TC/HDL-c, PAI-1, FTAFI, IL6, TNF-a.

  • The effect of Body Weight Support Treadmill Training (BWSTT) on aerobic fitness in people with Spinal Cord Injury (SCI) at 6-months of exercise and 6-months post intervention. [ Time Frame: Assessed at baseline, 6-months and 6-months post-intervention. ] [ Designated as safety issue: No ]
    Aerobic fitness will be assessed via a VO2Peak tests completed on an arm cycle ergometer. We will record Resting ECG, Blood Pressure, RPE, Oxygen Consumption and VO2Peak as well as feedback from the Positive and Negative Affect Scale and Visual Analogue Pain Scale.

  • The effect of Body Weight Support Treadmill Training (BWSTT) on quality of life in people with Spinal Cord Injury (SCI) at 3- and 6-months of exercise and 6-months post intervention. [ Time Frame: Assessed at baseline, 3- and 6-months and 6-months post-intervention ] [ Designated as safety issue: No ]

    Quality of life (qoL) will be assessed through questionnaires administered centrally by Dr. Kathleen Martin-Ginis of McMaster University in Hamilton, Ontario.

    Questionnaires used to assess QoL are Leisure-Time Physical Activity, Questionnaire for People with SCI, MOS-36 Pain and Health Subscales, Autonomic Questionnaire, Satisfaction with Life Scale, Life Satisfaction Questionnaire, Self-Efficacy for Aerobic Exercise, Spinal Cord Independence Measure, Impact on Participation and Autonomy Questionnaire



Estimated Enrollment: 20
Study Start Date: January 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Body Weight Supported Treadmill Training
BWSTT protocol will consist of training of individuals with complete SCI on a treadmill with a body weight support system. BWSTT is assisted by three individuals who participate in training. One trainer provides support at the hip, and one trainer at each leg. The participant will be fitted with a harness while seated in their wheelchair and then wheeled up a ramp to the treadmill. Cables attached to the harness will be used to hoist the participant into a standing position. Appropriate body weight support will be set according to the suggested Hocoma locomotor training protocol, in which weight is added until the participant is in dynamic support as indicated by the dynamic gauge on the treadmill. Dynamic support is usually indicated at the weight where participants do not have knee-buckling during a static standing position; however, this may not be observed in all severe, motor-complete SCI participants.
Other: Body Weight Supported Treadmill Training
BWSTT protocol will consist of training of individuals with complete SCI on a treadmill with a body weight support system. BWSTT is assisted by three individuals who participate in training. One trainer provides support at the hip, and one trainer at each leg. The participant will be fitted with a harness while seated in their wheelchair and then wheeled up a ramp to the treadmill. Cables attached to the harness will be used to hoist the participant into a standing position. Appropriate body weight support will be set according to the suggested Hocoma locomotor training protocol, in which weight is added until the participant is in dynamic support as indicated by the dynamic gauge on the treadmill. Dynamic support is usually indicated at the weight where participants do not have knee-buckling during a static standing position; however, this may not be observed in all severe, motor-complete SCI participants.
Other Name: BWSTT
Active Comparator: Arm Cycle Ergometry Training

Arm Cycle Ergometry Training ACET will be performed on an arm-cycle ergometer against individually determined levels of resistance. Upright hand cuffs will be used so that the hand will be placed with the thumb pointing downward, and the ergometer will be positioned so that the arm never exceeded the height of the shoulder.

The end objective is for the individual to complete 30-minutes of exercise in 2, 15-minute bouts. For safety reasons, stop criteria for individual sessions will be set and participants will have a rest period of 5 minutes and afterwards asked if they want to stop exercise, or resume the session.

Other: Arm Cycle Ergometry Training

Arm Cycle Ergometry Training ACET will be performed on an arm-cycle ergometer against individually determined levels of resistance. Upright hand cuffs will be used so that the hand will be placed with the thumb pointing downward, and the ergometer will be positioned so that the arm never exceeded the height of the shoulder.

The end objective is for the individual to complete 30-minutes of exercise in 2, 15-minute bouts. For safety reasons, stop criteria for individual sessions will be set and participants will have a rest period of 5 minutes and afterwards asked if they want to stop exercise, or resume the session.

Other Name: ACET

Detailed Description:
  1. Purpose To determine whether body weight-supported treadmill training (BWSTT) has beneficial effects, over and above arm-cycle ergometry training (ACET), on arterial stiffness (aortic pulse wave velocity, aPWV) and secondary health outcomes (cardiovascular, autonomic and metabolic indices, fitness, body composition, and quality of life) in individuals with chronic (≥ 2 years post-injury) motor-complete cervical and high-thoracic SCI.
  2. Hypothesis Through large muscle mass involvement and postural challenge, the physical and metabolic stimuli of BWSTT will reduce aortic pulse wave velocity (aPWV) by 1 m/s in individuals with established risk (i.e. aPWV ≥ 13 m/s).
  3. Justification for the study Cardiovascular disease (CVD) is leading cause of morbidity and mortality in the SCI population. It is most commonly attributed to decreased physical activity levels; therefore strategies for decreasing CVD risk are centred on increasing physical activity. Unfortunately, the exercise-training literature in populations with SCI is limited, making it difficult to design evidence-based exercise prescriptions. ACET is widely used by individuals with SCI, but there is limited evidence on its ability to improve cardiovascular health. Given the evidence linking cardiovascular measures, specifically aPWV, and CVD risk, an exercise prescription, which is capable of eliciting both acute cardiovascular responses and chronic cardiovascular adaptations, is crucial. BWSTT has demonstrated favorable cardiovascular adaptations, but is primarily employed in individuals with incomplete SCI due to the nature of the exercise. While preliminary evidence in individuals with complete SCI suggest it may have favorable training effects, its effectiveness in a large sample of individuals with chronic, motor-complete, severe SCI has yet to be established.
  4. Objectives Cardiovascular adaptations in individuals with SCI predispose them to complex secondary health problems. This study will use a comprehensive assessment of cardiovascular risk factors and two different exercise interventions to assist in developing cardiovascular risk profiles and determining if BWSTT has greater efficacy than traditional exercise interventions (ACET) for decreasing cardiovascular risk in individuals with high, severe SCI.
  5. Research Method This study will employ a prospective, multi-centre, randomized, controlled, single-blinded clinical trial. A total of 60 participants (20 per site) between 18-60 years of age who have sustained a motor-complete (i.e., C4-T6, AIS A or B) traumatic SCI ≥ 2 years prior will be recruited. Only individuals with aPWV ≥ 13 m/s will be eligible to participate. The primary outcome measure (aPWV), and secondary cardiovascular and autonomic parameters will be assessed using a combination of electrocardiography, ultrasound, blood pressure, and applanation tonometry techniques. Fitness will be determined using a peak oxygen consumption test on a arm-cycle ergometer. Body composition will be determined using a dual energy x-ray absorbitrometry (DXA) scan. Metabolic indices will be determined from blood sampling. Lastly, quality of life and physical activity levels will be assessed using questionnaires. Measurements will take place at baseline (via participation in Study 1), and 3 and 6-months of exercise training, and following the completion of 6-months of exercise training. Training will involve 3, 60-minute exercise sessions per week, for 24 weeks. Both BWSTT and ACET sessions will take place at the Blusson Spinal Cord Centre at International Collaboration On Repair Discoveries (ICORD).
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-60 years of age
  • Motor-complete SCI (AIS A or B)
  • Severe SCI (C4-T6)
  • Individuals must be competent to give informed consent.
  • aPWV ≥ 13 m/s

Exclusion Criteria:

  • History and/or symptoms of CVD or cardiopulmonary problems/disease.
  • Major trauma or surgery within the last 6 months.
  • Active Stage 3 or 4 pressure ulcer (based on the National Pressure Ulcer Advisory Panel classification)
  • Recent (within 1 year) history of lower-extremity or non-union fracture
  • Any unstable medical/psychiatric condition or substance abuse disorder that is likely to affect their ability to complete this study.
  • Individuals with active medical issues such as pressure sores, urinary tract infections, hypertension, or heart disorders.
  • Any cognitive dysfunction or language barrier that would prevent subjects from following English instructions.
  • Subjects may be excluded at the discretion of the principal investigator due to other, unforeseen, safety issues.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01718977

Contacts
Contact: Andrei V Krassioukov, M.D., PhD 604-675-8819 andre.krassioukov@vch.ca

Locations
Canada, British Columbia
International Collaboration On Repair Discoveries Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Cameron M Gee, MExSc    6046758856    cgee@icord.org   
Principal Investigator: Andrei V Krassioukov, MD, PhD         
Canada, Ontario
McMaster University Recruiting
Hamilton, Ontario, Canada, L8S 4L8
Contact: Maureen McDonald, PhD    905 525 9140      
Principal Investigator: Maureen McDonald, PhD         
Sub-Investigator: Audrey Hicks, PhD         
Sub-Investigator: Kathleen Martin-Ginis, PhD         
Toronto Rehabilitation Institute Recruiting
Toronto, Ontario, Canada
Contact: Cathy Craven, MD    416-597-3422      
Principal Investigator: Cathy Craven, MD         
Sub-Investigator: Molly Verrier, MHSc         
Sponsors and Collaborators
University of British Columbia
McMaster University
Toronto Rehabilitation Institute
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Andrei V Krassiokov, M.D., PhD ICORD
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01718977     History of Changes
Other Study ID Numbers: H12-02945
Study First Received: October 24, 2012
Last Updated: April 28, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Intervention
Body Weight Supported Treadmill Training
Arm Cycle Ergometry Training
Aortic Pulse Wave Velocity

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

ClinicalTrials.gov processed this record on October 21, 2014