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

NCT01718977 | Completed DMC

• 1 other identifier: H12-02945
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 3

Brief Summary

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 carotid-to-femoral pulse wave velocity (cfPWV) 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 cfPWV and lower CVD risk in individuals with SCI.

Conditions

Spinal Cord Injury

Keywords

Intervention; Body Weight Supported Treadmill Training; Arm Cycle Ergometry Training; carotid-to-femoral pulse wave velocity

Outcome Measures

Primary Outcomes (1)

• The effect of Body Weight Support Treadmill Training (BWSTT) on carotid-to-femoral pulse wave velocity (cfPWV) in people with Spinal Cord Injury (SCI) at 3- and 6-months of exercise.

  cfPWV assessed at baseline, 3- and 6-months.

Secondary Outcomes (6)

• 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.

  Assessed at baseline, 3- and 6-months.

• The effect of 6-months Body Weight Support Treadmill Training (BWSTT) on Autonomic function in people with Spinal Cord Injury (SCI).

  Assessed at baseline and 6-months.

• The effect of Body Weight Support Treadmill Training (BWSTT) on Body Composition in people with Spinal Cord Injury (SCI) following 6-months of exercise.

  Assessed at baseline and 6-months.

• The effect of Body Weight Support Treadmill Training (BWSTT) on Metabolic and hematological parameters in people with Spinal Cord Injury (SCI) following 6-months of exercise.

  Assessed at baseline and 6-months.

• The effect of Body Weight Support Treadmill Training (BWSTT) on aerobic fitness in people with Spinal Cord Injury (SCI) following 6-months of exercise.

  Assessed at baseline and 6-months.

Study Arms (2)

Body Weight Supported Treadmill Training

EXPERIMENTAL

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

Arm Cycle Ergometry Training

ACTIVE COMPARATOR

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

Interventions

Body Weight Supported Treadmill Training OTHER

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.

Also known as: BWSTT

Body Weight Supported Treadmill Training

Arm Cycle Ergometry Training OTHER

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.

Also known as: ACET

Arm Cycle Ergometry Training

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years of age
• Motor-complete SCI (AIS A or B)
• Severe SCI (C4-T6)
• Individuals must be competent to give informed consent.
• cfPWV above median for age:
• \< 30 years = 6.1 m/s
• years = 6.4 m/s
• years = 6.9 m/s
• years = 8.1 m/s
• ≥ 60 years = 9.7 m/s

You may not qualify if:

• 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.
• Weighing \>135 kg (absolute weight capacity of the body weight-supported treadmill).

Sponsors & Collaborators

• University of British Columbia: lead
• McMaster University: collaborator
• Toronto Rehabilitation Institute: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (3)

International Collaboration On Repair Discoveries

Vancouver, British Columbia, V5Z 1M9, Canada

Location

McMaster University

Hamilton, Ontario, L8S 4L8, Canada

Location

Toronto Rehabilitation Institute

Toronto, Ontario, Canada

Location

Related Publications (3)

• Krassioukov AV, Currie KD, Hubli M, Nightingale TE, Alrashidi AA, Ramer L, Eng JJ, Ginis KAM, MacDonald MJ, Hicks A, Ditor D, Oh P, Verrier MC, Craven BC. Effects of exercise interventions on cardiovascular health in individuals with chronic, motor complete spinal cord injury: protocol for a randomised controlled trial [Cardiovascular Health/Outcomes: Improvements Created by Exercise and education in SCI (CHOICES) Study]. BMJ Open. 2019 Jan 4;9(1):e023540. doi: 10.1136/bmjopen-2018-023540.

  PMID: 30612110 BACKGROUND

• Dorey TW, Nightingale TE, Alrashidi AA, Thomas S, Currie KD, Hubli M, Balthazaar SJT, Krassioukov AV. Effects of exercise on autonomic cardiovascular control in individuals with chronic, motor-complete spinal cord injury: an exploratory randomised clinical trial. Spinal Cord. 2024 Oct;62(10):597-604. doi: 10.1038/s41393-024-01019-z. Epub 2024 Aug 31.

  PMID: 39217247 DERIVED

• Alrashidi AA, Nightingale TE, Currie KD, Hubli M, MacDonald MJ, Hicks AL, Oh P, Craven BC, Krassioukov AV. Exercise Improves Cardiorespiratory Fitness, but Not Arterial Health, after Spinal Cord Injury: The CHOICES Trial. J Neurotrauma. 2021 Nov 1;38(21):3020-3029. doi: 10.1089/neu.2021.0071. Epub 2021 Sep 3.

  PMID: 34314235 DERIVED

Related Links

• Trial Protocol

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Andrei V Krassiokov, M.D., PhD

  ICORD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 24, 2012
• First Posted: November 1, 2012
• Study Start: January 1, 2013
• Primary Completion: October 17, 2019
• Study Completion: October 17, 2019
• Last Updated: December 2, 2019

Record last verified: 2019-11

Locations

CA (3)