NCT06321172

Muscle and Bone Changes After 6 Months of FES Cycling

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: IRCCS Eugenio Medea · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 question\[s\] 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 T2(6 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.

Conditions

• Spinal Cord Injuries

Interventions

Type	Name	Description
DEVICE	FES Bike	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 the 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 starts 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.

Timeline

• Start date: 2022-09-09
• Primary completion: 2024-01-22
• Completion: 2024-04-29
• First posted: 2024-03-20
• Last updated: 2024-10-08

Locations

1 site across 1 country: Italy