跳至主要内容
临床试验/NCT07763002
NCT07763002招募中不适用

Acute Effects of Functional Inspiratory Muscle Training on Exercise Capacity, Muscle Oxygenation, Balance, and Agility in Elite Male Volleyball Players

Gazi University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
Change in Quadriceps Total Hemoglobin During the Incremental Shuttle Walk Test

研究概览

简要总结

This randomized controlled trial evaluates the acute effects of a single session of functional inspiratory muscle training on muscle oxygenation, exercise capacity, dynamic balance, and agility in elite male volleyball players aged 18 to 25 years. Thirty participants will be randomly assigned in a 1:1 ratio to an intervention group or a no-intervention control group. The intervention group will perform 60 resisted breaths at 50% of maximal inspiratory pressure using a POWERbreathe device during a sport-specific fixed-ball throwing drill. Both groups will complete assessments before and immediately after the intervention period on the same day. Quadriceps muscle oxygen saturation and total hemoglobin will be measured using a Moxy near-infrared spectroscopy monitor during the Incremental Shuttle Walk Test. Exercise capacity, dynamic balance, and agility will be assessed using the Incremental Shuttle Walk Test, Star Excursion Balance Test, and T-Test, respectively.

详细描述

This prospective, randomized, controlled, parallel-group interventional study is designed to investigate the acute effects of a single session of functional inspiratory muscle training on muscle oxygenation, functional exercise capacity, dynamic balance, and agility in elite male volleyball players aged 18 to 25 years. The study is conducted at the Cardiopulmonary Rehabilitation Unit, Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Gazi University. A total of 30 participants are planned, with 15 participants allocated to the functional inspiratory muscle training group and 15 participants allocated to the no-intervention control group.

After eligibility screening and written informed consent, participants are randomly assigned to the study groups in a 1:1 ratio. The computer-generated allocation sequence is created using the Sealed Envelope online randomization service. Outcome assessments are performed by physiotherapists who are not informed of group allocation. Participants and the personnel administering the training cannot be masked because participants in the intervention group use a POWERbreathe inspiratory muscle training device, whereas participants in the control group receive no sham inspiratory muscle training. Therefore, the study uses single masking at the level of the outcome assessor. When feasible, the statistician will receive the dataset with the treatment groups coded.

Before the training session, maximal inspiratory pressure is measured in the intervention group using a mouth pressure meter to determine the individual training resistance. Participants are assessed in a seated position while wearing a nose clip and maintaining a complete seal around the mouthpiece. After a complete expiration to residual volume, participants are instructed to perform a maximal inspiratory effort. At least three acceptable maneuvers are performed, with a 30-second rest period between maneuvers. When the difference between repeated measurements is less than 10%, the highest value is recorded as maximal inspiratory pressure in cmH2O. The training resistance is set at 50% of the individual maximal inspiratory pressure. Because maximal inspiratory pressure is measured only to determine the intervention dose and is not assessed before and after the study period in both groups, it will not be treated as a comparative study outcome.

Following warm-up, participants in the intervention group perform functional inspiratory muscle training using a POWERbreathe pressure-threshold device while completing a sport-specific fixed-ball throwing drill. The session consists of two sets of 30 resisted inspirations, corresponding to a total of 60 breaths. The session lasts approximately 10 to 12 minutes. Inspiration is performed against a resistance equivalent to 50% of the participant's maximal inspiratory pressure, whereas expiration is unrestricted. The training is integrated into the throwing drill without intentionally interrupting the participant's sport-specific movement pattern. Participants in the control group receive no inspiratory muscle training or sham respiratory intervention and undergo the same pre-intervention and post-intervention outcome assessments.

All outcome assessments are conducted before and immediately after the single-session intervention or corresponding control period on the same day. The post-intervention assessments are intended to determine the immediate acute response to the training session. The main muscle oxygenation outcomes are quadriceps muscle oxygen saturation and total hemoglobin. Functional exercise capacity, dynamic balance, and agility are evaluated as additional outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

盲法说明

Outcome assessments are performed by physiotherapists who are not informed of participant allocation. The intervention is not masked to participants or personnel administering the training because the intervention group uses a POWERbreathe device and the control group receives no sham intervention. Group labels will be coded for statistical analysis when feasible.

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
Male
接受健康志愿者
否

入选标准

  • •Male, aged 18 to 25 years
  • •Regular participation in volleyball training
  • •University student actively playing on an elite-level volleyball team
  • •Regular training during the previous 3 months
  • •Willing and able to provide written informed consent

排除标准

  • •Current smoking or regular alcohol use
  • •Regular use of medication or vitamin supplements
  • •History of upper respiratory tract infection or COVID-19 within the previous 3 months
  • •Lower-extremity or shoulder surgery within the previous 6 months
  • •An acute respiratory or musculoskeletal condition that prevents safe completion of the protocol
  • •Inability to complete the assessment or training procedures

研究组 & 干预措施

Functional Inspiratory Muscle Training

Experimental

Fifteen participants are planned for this arm. After warm-up, participants perform a sport-specific fixed-ball throwing drill while completing a single session of functional inspiratory muscle training using a POWERbreathe device. The resistance is set at 50% of the individual's maximal inspiratory pressure. Training consists of two sets of 30 resisted breaths, for a total of 60 breaths over approximately 10 to 12 minutes.

干预措施: Functional Inspiratory Muscle Training With POWERbreathe (Device)

No-Intervention Control

No Intervention

Fifteen participants are planned for this arm. Participants receive no inspiratory muscle training and complete the same pre-intervention and post-intervention outcome assessments as the intervention group on the same day.

结局指标

主要结局

Change in Quadriceps Total Hemoglobin During the Incremental Shuttle Walk Test

时间窗: Baseline and immediately after the single-session intervention or control period, within the same day

Total hemoglobin (THb, g/dL) will be recorded continuously using a Moxy near-infrared spectroscopy monitor positioned over the midpoint of the right quadriceps femoris. Mean THb will be summarized separately for the pre-exercise rest, exercise, and recovery phases of the Incremental Shuttle Walk Test. For each phase, change will be calculated as the post-intervention value minus the pre-intervention value. The primary comparison will be the difference in pre-to-post change between the intervention and control groups.

Change in Quadriceps Muscle Oxygen Saturation During the Incremental Shuttle Walk Test

时间窗: Baseline and immediately after the single-session intervention or control period, within the same day

Muscle oxygen saturation (SmO2, %) will be recorded continuously using a Moxy near-infrared spectroscopy monitor positioned over the midpoint of the right quadriceps femoris. Mean SmO2 will be summarized separately for the pre-exercise rest, exercise, and recovery phases of the Incremental Shuttle Walk Test. For each phase, change will be calculated as the post-intervention value minus the pre-intervention value. The primary comparison will be the difference in pre-to-post change between the intervention and control groups.

次要结局

  • Change in Incremental Shuttle Walk Test Distance(Baseline and immediately after the single-session intervention or control period, within the same day)
  • Change in Normalized Star Excursion Balance Test Reach Distance(Baseline and immediately after the single-session intervention or control period, within the same day)
  • Change in T-Test Agility Completion Time(Baseline and immediately after the single-session intervention or control period, within the same day)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Meral Boşnak Güçlü

Prof. Dr.

Gazi University

研究点 (1)

Loading locations...

相似试验