Physical ExerciseNCT06391658
Functional Training Improves the Functional Capacity and Physical Fitness of People Whit Spinal Cord Injury
A study testing Functional Training in people with Physical Exercise and Disability Physical, run by Centro Universitário Augusto Motta at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Exercise, Disability Physical
- What is being tested?
- Functional Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteBrazil
- Study dates
- 14 Apr 2021to 24 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women;
- Aged 18 or over
- Have had Spinal Cord Injury for at least two years
- Wheelchair users
Who cannot join
- Individuals who had clinical or physical conditions that prevented them from carrying out the proposed tests
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Eight Weeks of Functional Training Improves the Functional Capacity and Physical Fitness of People Whit Spinal Cord Injury After Social Distancing Due to the Covid-19 Pandemic
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?
Read more
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).
Read the detailed description
The spinal cord is an important component of the central nervous system, whose function is to transmit motor nerve impulses from the brain to other parts of the body, and to transmit sensory impulses from other systems of the body to the brain. Among adults living with SCI, studies show that participation in physical exercise programs, such as functional training, is associated with numerous health-related benefits, including improvements in cardiorespiratory fitness, energy production, and muscle strength, reduced the risk of cardiometabolic diseases and osteoporosis, in addition to psychosocial and quality of life benefits. However, high rates of physical inactivity among people with SCI are still a reality and, therefore, a cause for medical and health concern. In the recent scenario, measures to prevent and contain COVID-19 further contributed to the increase in sedentary time and behavior among individuals with spinal cord injury. Considering that TF aims to enhance specific actions in activities of daily living, the hypothesis of the cohort study is that a positive effect will be observed on functional capacity, on elements of physical fitness of these individuals and on quality of life after 8 weeks of training functional. Participants will be recruited by convenience and will undergo assessments of body composition, functional capacity, physical fitness and quality of life pre and post eight weeks of functional training, three times a week.
- Conditions
- Physical Exercise, Disability Physical
- Being tested
- Functional Training
- Keywords
- Rehabilitation, Spinal Cord Injury, Physical Disability, Physical Training.COVID-19
- Medical subject headings
- Motor Activity, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional TrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| FT group | Experimental | Functional Training group Receives: Other: Functional Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Eigth weeks
Secondary outcomes (2)
Arm muscle circumference
Arm muscle circumference was calculated using the equations proposed by Gurney and Jelliffe (1973): CMB (cm) = [Arm circumference (cm) - (π x triceps skinfold (mm))]
Measured: Eigth weeks
Perceived quality of life
Quality of life was investigated by applying the World Health Organization Quality of Life Questionnaire for People with Disabilities module ((WHOQOL-DIS), in the version translated and validated for Portuguese (Bredemeier et al., 2014). The options for each item are described on a five-level Likert scale, where participants rate satisfaction from 1 to 5 (5 "totally agree" and 1 "totally disagree"). The results were presented on a scale of 0 to 100 (WHOQOL,1998), scaled in a positive direction. In other words, the higher the score, the greater the interviewee's perception of QoL in each domain (WHOQOL,1998).
Measured: Eigth weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start14 Apr 2021
- Primary completion14 Feb 2022
- Study completion24 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Universitário Augusto Motta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Larissa Barranco, Principal investigator, Centro Universitário Augusto Motta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06391658
- Sponsor's protocol ID
- 54458021.8.0000.5235
- Status last verified
- Apr 2024
- First submitted
- 23 Apr 2024
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eight Weeks of Functional Training Improves the Functional Capacity and Physical Fitness of People Whit Spinal Cord Injury After Social Distancing Due to the Covid-19 Pandemic
- ClinicalTrials.gov ID
- NCT06391658
- Acronym / sponsor ID
- 54458021.8.0000.5235
- Conditions
- Physical Exercise, Disability Physical
- Keywords
- Rehabilitation, Spinal Cord Injury, Physical Disability, Physical Training.COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Centro Universitário Augusto MottaUniversity, hospital or other
- Study start
- 14 Apr 2021 (actual)
- Primary completion
- 14 Feb 2022 (actual)
- Study completion
- 24 Oct 2022 (actual)
- First posted
- 30 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The spinal cord is an important component of the central nervous system, whose function is to transmit motor nerve impulses from the brain to other parts of the body, and to transmit sensory impulses from other systems of the body to the brain. Among adults living with SCI, studies show that participation in physical exercise programs, such as functional training, is associated with numerous health-related benefits, including improvements in cardiorespiratory fitness, energy production, and muscle strength, reduced the risk of cardiometabolic diseases and osteoporosis, in addition to psychosocial and quality of life benefits. However, high rates of physical inactivity among people with SCI are still a reality and, therefore, a cause for medical and health concern. In the recent scenario, measures to prevent and contain COVID-19 further contributed to the increase in sedentary time and behavior among individuals with spinal cord injury. Considering that TF aims to enhance specific actions in activities of daily living, the hypothesis of the cohort study is that a positive effect will be observed on functional capacity, on elements of physical fitness of these individuals and on quality of life after 8 weeks of training functional. Participants will be recruited by convenience and will undergo assessments of body composition, functional capacity, physical fitness and quality of life pre and post eight weeks of functional training, three times a week.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FT group | Experimental | Other: Functional TrainingFunctional Training group |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women;
- Aged 18 or over
- Have had Spinal Cord Injury for at least two years
- Wheelchair users
Key exclusion criteria (1 listed)
- Individuals who had clinical or physical conditions that prevented them from carrying out the proposed tests
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional TrainingFunctional 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. | Other | FT group |
Primary outcome
Functional capacity with Battery of Motor Tests related to Functional Independence
Time frame: Eigth weeks
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).
Functional capacity with Motor Assessment Scale
Time frame: Eigth weeks
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.
Isometric handgrip strength
Time frame: Eigth weeks
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.
Upper limb power
Time frame: Eigth weeks
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.
Agility
Time frame: Eigth weeks
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.
Aerobic capacity
Time frame: Eigth weeks
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.
2 secondary outcomes
Arm muscle circumference
Time frame: Eigth weeks
Perceived quality of life
Time frame: Eigth weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
Related trials for Physical Exercise
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Larissa Barranco principal investigator
Centro Universitário Augusto Motta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Training in people with Physical Exercise and Disability Physical, run by Centro Universitário Augusto Motta at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional capacity with Battery of Motor Tests related to Functional Independence (time frame: Eigth weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2024.