Effect of Three Training Programs on the Cardiovascular Condition of Individuals with Spinal Cord Injury

NCT06627881 | Unknown

• 1 other identifier: 01/24
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: Describe the effect of different aerobic training programs on the autonomic nervous system (ANS), cardiovascular condition, body composition, metabolic profile, movement and functional independence in patients with spinal cord injury (SCI). Design: Randomized clinical trial Participants: Individuals in the chronic phase of SCI. Interventions: Three training programs: continuous aerobic in kayak, aerobic resistance circuit, and high-intensity interval with rope. The main measures to be explored will be the potential effects of training on heart rate variability as an indicator of autonomic function; measurement of oxygen consumption (VO2max) and resting metabolic unit (METs) for cardiovascular fitness; bone density examination (DXA) for body composition, metabolic profile, functional independence and life satisfaction in individuals with SCI. Results: The 8-week training program will increase METs and VO2max, improve heart rate variability and anthropometric variables, body composition, and metabolic profile

Conditions

Spinal Cord Injuries; Cardiovascular Condition; Exercise

Outcome Measures

Primary Outcomes (3)

• Measured metabolic equivalents

  Metabolic unit of measurement that indicates the ml of oxygen consumed per kg/min

  Before training and 8 weeks

• Oxygen consumption (VO2máx)

  It is the largest amount of oxygen that the body can absorb, transport and consume in a given time.

  Before training and 8 weeks

• Low-high frequency ratio (LF/HF)

  Heart rate variability domain measurement

  Before training and 8 weeks

Secondary Outcomes (11)

• Satisfaction with life

  Before training and 8 weeks

• Spinal Cord Injury Independence Measure III

  Before training and 8 weeks

• Plasma glucose concentration.

  Before training and 8 weeks

• Plasma triglyceride concentration

  Before training and 8 weeks

• High-density lipoprotein cholesterol (HDL-C)

  Before training and 8 weeks

Study Arms (3)

Continuous aerobic kayak training program

EXPERIMENTAL

* Frequency: 5 days a week. * Intensity: moderate 40.59% RHR or Borg 12-13. Progressing 3rd week 60-70% FCR, Borg 14-17. * Time: 8 weeks * Volume: 5 min warm up upper body and center of the upper body 30 minutes of training Progression after 3 weeks: 35 min Total of 40 sessions.

Other: Continuous aerobic kayak training program

Aerobic Endurance Circuit Program

ACTIVE COMPARATOR

* Frequency: 5 days a week. * Intensity: Very light \<30% of 1 RM, Borg \<9 Progression in week 3: light 30-40% of 1 RM, Borg 9-11 * Time: 8 weeks * Volume: 30 min 5 min upper body and center warm-up 2 aerobic resistance circuits with 8 upper body and core exercises, 18-22 repetitions Week 3 progression: 3 circuits Week 4 progression: 4 circuits Recovery period between circuits: 3 min Total of 40 sessions.

Other: Aerobic Endurance Circuit Program

High intensity interval program with rope

ACTIVE COMPARATOR

* Frequency: 5 days a week. * Intensity: Vigorous \<30% of RHR, Borg 14-17 with recovery interval intensity of 30-39% of RHR Borg 9-11 * Time: 8 weeks * Volume: 30 min 5 min upper body and center warm-up Start: 1:3 ratio, intensive intervals lasting 1 min and recovery interval of 3 min, performing 7 intervals with a total duration of 28 min Progression week 3: Interval ratio will be modified 1:2, performing 10 intervals. Total of 40 sessions.

Other: High intensity interval program with rope

Interventions

Continuous aerobic kayak training program OTHER

Sitting in a special chair on the Kayak Pro® Speed Stroke PRO ergometer. 5-minute warm-up and continuous training, for 30 minutes on the ergometer at a moderate to vigorous intensity, 5 days a week.

Continuous aerobic kayak training program

Aerobic Endurance Circuit Program OTHER

Sitting with feet flat on the floor and shoulder-width apart, in each session with a 5-minute warm-up, light intensity training with upper body strengthening, 5 days a week.

Aerobic Endurance Circuit Program

High intensity interval program with rope OTHER

Sitting with feet flat on the floor and shoulder-width apart, in each session with a 5-minute warm-up, vigorous intensity undulating rope training using the interval method, 5 days a week.

High intensity interval program with rope

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of spinal cord injury with any American Spinal Injury Association Impairment Scale (AIS) classification
• Neurologic level below C8
• Time since injury greater than 6 months
• Any etiology
• Any type (complete and incomplete)
• Adequate trunk control (trunk control scale \>13 points)

You may not qualify if:

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

Sponsors & Collaborators

• Instituto Nacional de Rehabilitacion: lead

Study Sites (1)

Instituto Nacional de Rehabilitación "Luis Guillermo Ibarra Ibarra"

Mexico City, Mexico City, 14389, Mexico

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries; Motor Activity

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Marlene A. Rodríguez Barragán, MD, MSc

CONTACT

+525559991000; opus.mars@gmail.com

Jimena Quinzaños Fresnedo, MD, PhD

CONTACT

+525559991000; jquinzanos@inr.gob.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Those in charge of evaluating results and the person in charge of statistical analysis will be blinded and will not know the assignment of the intervention. The person in charge of carrying out the assigned exercise and the participant will know the assignment of the intervention.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc

Model Details: Randomized clinical trial

Study Record Dates

• First Submitted: October 3, 2024
• First Posted: October 4, 2024
• Study Start: January 25, 2023
• Primary Completion: January 25, 2023
• Study Completion: January 30, 2026
• Last Updated: October 4, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: After January 2026 for 5 years
• Access Criteria: Ask the authors directly by e-mail

Locations

ME (1)