Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06321172
Status:
COMPLETED
Last Update Posted:
2024-03-22
First Post:
2024-03-14
Brief Title:
Muscle and Bone Changes After 6 Months of FES Cycling
Sponsor:
IRCCS Eugenio Medea
Organization:
IRCCS Eugenio Medea
Study Overview
Official Title:
Preliminary Evaluation of the Effectiveness of FES Cycling in Terms of Training Performance Morpho-functional Characteristics of the Leg Muscles and Bone Trophism After 6 Months of Training in Spinal Cord Injury Subjects
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FES-Bike
Brief Summary:
The goal of this clinical trial is to assess the effectiveness of FES cycling in terms of changes morpho-functional characteristics of the leg muscles training performance and bone trophism in 5 subjects with Spinal Cord Injury after 6 months of training The main questions it aims to answer are
Do the morpho-functional characteristics of the leg muscles improve after 3 and 6 months of training with FES cycling If any the morpho-functional improvements are maintained one month after the end of the training
Does the quality of the leg bones improve after 3 and 6 months of training with FES cycling
Does the training performance improve during the training with FES cycling
Do the data referred to the vegetative nervous system change after 3 and 6 months of training with FES cycling If yes the changes in the vegetative nervous system are maintained one month after the end of the training
Does the intestinal function change after 3 and 6 months of training with FES cycling If yes the changes are maintained one month after the end of the training
Does the level of spasticity of the lower limbs change after 3 and 6 months of training with FES cycling If yes the changes are maintained one month after the end of the training
Does the level of pain perceived by pilots change after 3 and 6 months of training with FES cycling If yes the changes are maintained one month after the end of the training
Does the Psychological General Well-Being of the pilots change after 3 and 6 months of training with FES cycling If yes the changes are maintained one month after the end of the training
Does the pilots motivation in carrying out a sporting activity change between T1 3 months after starting the training and T26 months after starting the training
Participants will train for 6 months with FES-cycling twice a week Each session includes at most 30 minutes of stimulation
Do the morpho-functional characteristics of the leg muscles improve after 3 and 6 months of training with FES cycling If any the morpho-functional improvements are maintained one month after the end of the training
Does the quality of the leg bones improve after 3 and 6 months of training with FES cycling
Does the training performance improve during the training with FES cycling
Do the data referred to the vegetative nervous system change after 3 and 6 months of training with FES cycling If yes the changes in the vegetative nervous system are maintained one month after the end of the training
Does the intestinal function change after 3 and 6 months of training with FES cycling If yes the changes are maintained one month after the end of the training
Does the level of spasticity of the lower limbs change after 3 and 6 months of training with FES cycling If yes the changes are maintained one month after the end of the training
Does the level of pain perceived by pilots change after 3 and 6 months of training with FES cycling If yes the changes are maintained one month after the end of the training
Does the Psychological General Well-Being of the pilots change after 3 and 6 months of training with FES cycling If yes the changes are maintained one month after the end of the training
Does the pilots motivation in carrying out a sporting activity change between T1 3 months after starting the training and T26 months after starting the training
Participants will train for 6 months with FES-cycling twice a week Each session includes at most 30 minutes of stimulation
Detailed Description:
Six months of FES-cycling trainings twice a week is performed for each pilot Each session includes at most 30 minutes of stimulation
At the beginning of training period a conditioning phase is performed until the pilot reaches pedalling autonomy This period is also used to define the stimulation parameters minimum and maximum values of current intensity and pulse width reference cadence and gear specific for the ability of each pilot Then the training period start and is performed indoor setting the resistance of the smart trainer at 10 for all the participants The sessions are organized as follows a 3-minute warmup followed by four sets of 6 minutes of pedalling and a 3-minute cool down
At the beginning of training period a conditioning phase is performed until the pilot reaches pedalling autonomy This period is also used to define the stimulation parameters minimum and maximum values of current intensity and pulse width reference cadence and gear specific for the ability of each pilot Then the training period start and is performed indoor setting the resistance of the smart trainer at 10 for all the participants The sessions are organized as follows a 3-minute warmup followed by four sets of 6 minutes of pedalling and a 3-minute cool down
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None