Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06624566
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-11
Brief Title:
EINTER PROGRAM in Spinal Cord Injury Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
EINTER PROGRAM Intensive Therapeutic Exercise in Patients with Spinal Cord Injury
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study consists of the implementation of a therapeutic physical exercise program in a group setting in patients with spinal cord injury admitted to the Miguel Servet University Hospital in Zaragoza This program consists of performing strength and endurance exercises from Monday to Friday with a duration of approximately 45 minutes each session
The groups are created in such a way that the subjects in each group are homogeneous This homogeneity is classified according to whether or not trunk control in seated or standing position is maintained in an autonomous manner as measured by the Berg scale Each group consists of a maximum of 4 subjects and there are a maximum of 2 groups and 1 physiotherapist per group Group A is for those subjects who do not maintain independent standing but maintain trunk control while seated and group B is for those patients who do maintain independent standing
Prior to the start of the program subjects are informed of the study and evaluated with a series of health indicators scales to measure the impact of the program at the beginning of the program and at hospital discharge These scales are as follows
To measure muscular strength the investigators use the Medical Research Council and to measure aerobic endurance the investigators use the 6 Minute Walking Test for patients who can ambulate autonomously and the 6 Minutes Pushing Test for those patients who do not ambulate and move around in a wheelchair In addition the investigators pass a satisfaction
The groups are created in such a way that the subjects in each group are homogeneous This homogeneity is classified according to whether or not trunk control in seated or standing position is maintained in an autonomous manner as measured by the Berg scale Each group consists of a maximum of 4 subjects and there are a maximum of 2 groups and 1 physiotherapist per group Group A is for those subjects who do not maintain independent standing but maintain trunk control while seated and group B is for those patients who do maintain independent standing
Prior to the start of the program subjects are informed of the study and evaluated with a series of health indicators scales to measure the impact of the program at the beginning of the program and at hospital discharge These scales are as follows
To measure muscular strength the investigators use the Medical Research Council and to measure aerobic endurance the investigators use the 6 Minute Walking Test for patients who can ambulate autonomously and the 6 Minutes Pushing Test for those patients who do not ambulate and move around in a wheelchair In addition the investigators pass a satisfaction
Detailed Description:
Metabolic alterations in patients with spinal cord injury are associated among others with arterial hypertension lipid alterations hyperinsulinemia and glucose transport disorders which can lead to diabetes This may favor the appearance of obesity phenomena in this type of patients The decrease in physical exercise can increase these complications With an increase in the level of physical activity caloric expenditure is increased thus improving the transport of glucose in the blood and decreasing the processes of diabetes In addition movement components such as strength and endurance are improved which provides an improvement in balance Therefore with this increase in physical activity the investigators facilitate the patients greater participation in their environment once they are discharged from the hospital Within the hospital setting time away from scheduled therapy in patients with spinal cord injury on the Neurorehabilitation ward ULME constitutes the majority of their waking time when they are admitted to this ward Studies from other hospitals show that as a rule this time is approximately 4 hours a day of which only 7-10 minutes a day are devoted to moderate and vigorous physical activity For these reasons the investigators consider it very important to implement therapeutic exercise programs in people with neurological pathology in this case with a diagnosis of spinal cord injury and to verify the impact it has on strength and endurance in this population
The main hypothesis is that training through a designed program of therapeutic physical exercise optimizes the results referred to the improvement of strength and endurance in patients with spinal cord injury admitted to the Neurorehabilitation ward ULME of the Miguel Servet Hospital in Zaragoza
The secondary hypotheses are that training based on a designed program of therapeutic physical exercise is satisfactory for patients with spinal cord injury admitted to the Neurorehabilitation ward of the Miguel Servet Hospital of Zaragoza
The objectives of this study are
1 To improve the strength of patients with spinal cord injury at the ULME
2 To improve the aerobic endurance of the patient with spinal cord injury in the ULME
3 To increase the patients adherence to physiotherapy treatments
4 To assess patient satisfaction with their participation in therapeutic physical exercise programs
Sources of information Data regarding age sex and metabolic variables are extracted from the electronic medical record The strength and endurance variables are extracted from the assessment performed by the evaluating physiotherapists and saved in paper format and an Excel sheet These variables are collected before starting the EINTER program and at hospital discharge Likewise at hospital discharge a satisfaction survey and a personalized exercise sheet are provided The variables collected are o Muscular strength measured by the Medical Research Council o Aerobic endurance measured by the 6 Minute Walking Test for patients who can walk independently and the 6 Minutes Pushing Test for those patients who do not walk and move around in a wheelchair o Adherence measured by the number of sessions in which the patient has participated o Satisfaction survey
Before the patient starts the program heshe is classified in group A -patients who have seated trunk control for at least 2 minutes with supervision and no standing control Item 33 Berg scale- or in group B -patients who have standing trunk control for 2 minutes with supervision Item 23 on the Berg scale- There is a maximum of 4 patients per group with 1 physiotherapist per group
Statistical analysis For statistical analysis the program R Ver 413 R Foundation for Statistical Computing Institute for Statistics and Mathematics Welthandelsplatz 1 1020 Vienna Austria will be used The significance level will be set at pampampampampamplt005 The Kolmogorov-Smirnov test with Lilliefors correction will be used to test the distribution of quantitative variables Quantitative variables will be described with meanstandard deviation or median interquartile range according to their distribution and qualitative variables with absolute and relative values Pre-treatment differences will be analyzed with a t-test for related data or with the Wilcoxon signed-rank test for quantitative variables according to their distribution and with Fishers exact text for qualitative variables Limitations of the study One of the main limitations of the study is not being able to have a control group to be able to perform a Randomized Clinical Trial Another limitation is the few variables incorporated in the study For future studies it would be interesting to introduce variables related to the social participation of the patient in his environment once discharged from hospital
This study is based on an intervention based on therapeutic exercise a tool that is within the scope of competence of physical therapists therefore it is considered to be covered by the Civil Liability Insurance policy as professional members
The project is planned to be carried out in the multifunctional room of the Neurorehabilitation Department of the Miguel Servet University Hospital of Zaragoza The material to be used is the usual one for the professional practice of the physiotherapist and it is detailed below
4 SETS OF DUMBBELLS OF DIFFERENT WEIGHTS
3 PULSE OXIMETERS
3 MEDICINE BALLS OF DIFFERENT WEIGHTS
3 PAIRS OF DIFFERENT WEIGHTS
1 STRETCHER
1 MOTOMED
1 PARALLEL BARS
The main hypothesis is that training through a designed program of therapeutic physical exercise optimizes the results referred to the improvement of strength and endurance in patients with spinal cord injury admitted to the Neurorehabilitation ward ULME of the Miguel Servet Hospital in Zaragoza
The secondary hypotheses are that training based on a designed program of therapeutic physical exercise is satisfactory for patients with spinal cord injury admitted to the Neurorehabilitation ward of the Miguel Servet Hospital of Zaragoza
The objectives of this study are
1 To improve the strength of patients with spinal cord injury at the ULME
2 To improve the aerobic endurance of the patient with spinal cord injury in the ULME
3 To increase the patients adherence to physiotherapy treatments
4 To assess patient satisfaction with their participation in therapeutic physical exercise programs
Sources of information Data regarding age sex and metabolic variables are extracted from the electronic medical record The strength and endurance variables are extracted from the assessment performed by the evaluating physiotherapists and saved in paper format and an Excel sheet These variables are collected before starting the EINTER program and at hospital discharge Likewise at hospital discharge a satisfaction survey and a personalized exercise sheet are provided The variables collected are o Muscular strength measured by the Medical Research Council o Aerobic endurance measured by the 6 Minute Walking Test for patients who can walk independently and the 6 Minutes Pushing Test for those patients who do not walk and move around in a wheelchair o Adherence measured by the number of sessions in which the patient has participated o Satisfaction survey
Before the patient starts the program heshe is classified in group A -patients who have seated trunk control for at least 2 minutes with supervision and no standing control Item 33 Berg scale- or in group B -patients who have standing trunk control for 2 minutes with supervision Item 23 on the Berg scale- There is a maximum of 4 patients per group with 1 physiotherapist per group
Statistical analysis For statistical analysis the program R Ver 413 R Foundation for Statistical Computing Institute for Statistics and Mathematics Welthandelsplatz 1 1020 Vienna Austria will be used The significance level will be set at pampampampampamplt005 The Kolmogorov-Smirnov test with Lilliefors correction will be used to test the distribution of quantitative variables Quantitative variables will be described with meanstandard deviation or median interquartile range according to their distribution and qualitative variables with absolute and relative values Pre-treatment differences will be analyzed with a t-test for related data or with the Wilcoxon signed-rank test for quantitative variables according to their distribution and with Fishers exact text for qualitative variables Limitations of the study One of the main limitations of the study is not being able to have a control group to be able to perform a Randomized Clinical Trial Another limitation is the few variables incorporated in the study For future studies it would be interesting to introduce variables related to the social participation of the patient in his environment once discharged from hospital
This study is based on an intervention based on therapeutic exercise a tool that is within the scope of competence of physical therapists therefore it is considered to be covered by the Civil Liability Insurance policy as professional members
The project is planned to be carried out in the multifunctional room of the Neurorehabilitation Department of the Miguel Servet University Hospital of Zaragoza The material to be used is the usual one for the professional practice of the physiotherapist and it is detailed below
4 SETS OF DUMBBELLS OF DIFFERENT WEIGHTS
3 PULSE OXIMETERS
3 MEDICINE BALLS OF DIFFERENT WEIGHTS
3 PAIRS OF DIFFERENT WEIGHTS
1 STRETCHER
1 MOTOMED
1 PARALLEL BARS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None