NCT06391658

Brief Summary

The aim of this study is to understand the effect of adapted functional training on the physical fitness, functionality and quality of life of individuals with SCI after social distancing due to COVID-19. The main question\[s\] it aims to answer are:

  • Are the participants of the functional training program adapted for people with spinal cord injury show better results in functional capacity in post-test evaluations training period, when compared to your results in the functional training pré-period?
  • Is adapted functional training capable of improving cardiorespiratory fitness, muscular strength and body composition?
  • Can the perception of quality of life be influenced by functional training? Participants will be evaluated through questionnaires and field tests, such as:
  • Functional Capacity (battery of motor tests related to functional independence and Motor Assessment Scale),
  • Physical fitness (handgrip test; medicine ball throw; Illinois agility and 12-minute displacement) and Quality of Life (WHOQOL-DIS).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 14, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2022

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

April 23, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 30, 2024

Completed
Last Updated

April 30, 2024

Status Verified

April 1, 2024

Enrollment Period

10 months

First QC Date

April 23, 2024

Last Update Submit

April 25, 2024

Conditions

Keywords

RehabilitationSpinal Cord InjuryPhysical DisabilityPhysical Training.COVID-19

Outcome Measures

Primary Outcomes (6)

  • Functional capacity with Battery of Motor Tests related to Functional Independence

    The Motor Test Battery consisted of function and reach tests. After adding up the test scores, the individuals were classified as: "complete dependence" (0 to 6 points), "moderate autonomy" (7 to 13 points), "high autonomy" (14 to 20 points) and "total autonomy" (21 to 27 points).

    Eigth weeks

  • Functional capacity with Motor Assessment Scale

    The Motor Assessment Scale (Jorgensen et al., 2011) consists of six tests to assess static and proactive balance control, with the starting position being sitting on a bench, with hips and knees at 90º, without back support and feet on the floor. In each test, the testee can receive a score of 0 (does not perform the task and disqualifies the individual) or 1 (performs the task), with three possible attempts each.

    Eigth weeks

  • Isometric handgrip strength

    To assess physical fitness through musculoskeletal capacity, the Lafayette hand dynamometer hand grip test (kgf; Lafayette hand dynamometer; United States) was used in three attempts for both sides, where the highest number achieved was validated, with the measurements measured in KGF.

    Eigth weeks

  • Upper limb power

    A 3kg medicine ball throw test was carried out to assess the participant's muscle power. The participant had three attempts to throw the medicine ball as far as possible, with both hands at chest height. The distance, in meters (m), between the point where the ball touched the ground and the participant was measured and the lowest result of the three attempts was validated.

    Eigth weeks

  • Agility

    The Illinois Agility Test was carried out, which is used to measure multidirectional agility, both for disabled people in wheelchairs and for non-disabled people in clinical or athletic situations. To carry out the test, cones were used to mark out a pre-established route to be covered in the shortest time possible. The participant could make three attempts and the one with the shortest time, measured in seconds (s), was validated.

    Eigth weeks

  • Aerobic capacity

    Cardiorespiratory capacity was measured using the 12-minute walk test on a pre-defined course that was 25 meters long, 15 meters wide and marked off 2 meters at the corners, giving a total perimeter of 75.32 meters. The participants were asked to cover as much distance as possible, measured in miles (mi), during the 12 minutes.

    Eigth weeks

Secondary Outcomes (2)

  • Arm muscle circumference

    Eigth weeks

  • Perceived quality of life

    Eigth weeks

Other Outcomes (5)

  • Total body mass

    Eigth weeks

  • Height

    Eigth weeks

  • Body perimeters

    Eigth weeks

  • +2 more other outcomes

Study Arms (1)

FT group

EXPERIMENTAL

Functional Training group

Other: Functional Training

Interventions

Functional training was performed for eigth weeks. The group participated on the supervised training once a week and twice a week at home. The training was arranged in a circuit method, consisting of three to four blocks with two to three exercises each, with an execution time of two minutes and recovery of thirty seconds between exercises and one minute between each block. The exercises emphasized integrated, functional and multi-joint movements for mobility, flexibility, strength, power and muscular endurance with overload, as well as agility, speed and balance exercises.

FT group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women;
  • Aged 18 or over
  • Have had Spinal Cord Injury for at least two years
  • Wheelchair users

You may not qualify if:

  • Individuals who had clinical or physical conditions that prevented them from carrying out the proposed tests

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Universitário Augusto Motta

Rio de Janeiro, Brazil

Location

MeSH Terms

Conditions

Motor ActivitySpinal Cord Injuries

Condition Hierarchy (Ancestors)

BehaviorSpinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Larissa Barranco

    Centro Universitário Augusto Motta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2024

First Posted

April 30, 2024

Study Start

April 14, 2021

Primary Completion

February 14, 2022

Study Completion

October 24, 2022

Last Updated

April 30, 2024

Record last verified: 2024-04

Locations