跳至主要内容
临床试验/CTRI/2025/04/085805
CTRI/2025/04/085805尚未招募不适用

Additive Effect Of Inspiratory Muscle Training On Respiratory Muscle Strength, Single Breath Count And Kinesiophobia In Patients With Open Abdominal Surgery- An Experimental Study.

Achal Lathi1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年10月5日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Respiratory Muscle Strength , Single Breath Count and Kinesiophobia

研究概览

简要总结

  • Approval will be taken from Principal, the Institutional Ethical committee and respective unit head of surgery department and HOD of surgery department. Participants will be screened as per the inclusion and exclusion criteria. Aim, objectives & treatment procedure will be explained to the participants in there best possible language and consent will be taken. Participants will be selected by means of purposive sampling and allocation will be done by chit method in Group A (Intervention group) and Group B (Control group). Pre & post data will be collected on prior day of operation, POD 2nd,and  6th day , Respiratory strength will be measure by maximum inspiratory pressure by pressure manometer, Single breath count test & Kinesiophobia will be assessed. ·     MIP will be determined by measuring the upper airway pressure during maximum voluntary inspiration using Micro RPM.·     The MicroRPM is a small, portable, lightweight, noninvasive, mouth-pressure manometer with a rubber-flanged mouthpiece. The MicroRPM displays the test results in a device monitor, uses software and calculates the MIP values, in cmH2O, from the one-second average maximum pressure

·     According to the guidelines of the American Thoracic Society (ATS)/European Respiratory Society (ERS).

·     During the MIP measurement the participant will be asked to hold the gauge with both hands and to close his or her lips firmly around the flanged mouthpiece.

·     We applied a nose clip to avoid nasal air leak.

·     For the MIP maneuver the participant will be asked to exhale as much as possible (to residual volume) and then to inhale maximally for more than one second against the resistance of the gauge.

·     The measurements are repeated 3 times, taking the maximum value as a record.

 1)      Single Breath Count (ICC=0.976)

·     The participants will be asked to take a deep breath and count as far as possible in their normal speaking voice in a single inspiration without taking another breath while exhaling.

·     The participant will start counting from number 1 till the next inhalation.

·     Three attempts will be performed & recorded.

·     The best performance will be considered for final data analysis.

·     One minute rest will be provided between the consecutive performances.

 2)      Tampa scale of Kinesiophobia -11 (TSK-11) (ICC=0.93)

 •    A study by Woby for properties of the TSK-11 stated to evaluate movement/reinjury-related pain-related fear, the TSK-11 scale has been used.[13]

•    Response items are related to physical feelings (for example, “pain always means I’ve injured my body”) and activity avoidance (for example, “I’m afraid I’ll injure myself if I exercise”).

•    TSK-11 scores range from 11 to 44, with higher scores indicating greater pain-related fear of movement/reinjury.

•    On the TSK-11, the kinesiophobia categories are as follows:

•    11–22 (minimum),

•    23–28 (low),

•    29–35 (moderate), and

•    36–44 (high).  Intervention will be started on Post operative day 2nd.Group A (interventional group) will receive Inspiratory Muscle Training with 30% of initial Pimax preoperative, 5repetation of 3set with 2min rest between the set for 6 days per week, twice a day for 1 weeks, along with Conventional physiotherapy.1) Breathing Exercise 5-7 repetations will be given:

a) Diaphragmatic Breathing Exercise

b) Thoracic Expansion Exercise

c) lateral costal expansion technique

  1. Upper Limb (UL) & Lower Limb (LL) mobility exercise – 10 reps 1set

  2. Ambulation

4)Incentive spirometer 10 rep

6 days per week , 1 week , twice a day

**Group B (Control group):**Willreceive only conventional physiotherapy which includes

  1. Breathing Exercise 5-7 repetations will be given:

a) Diaphragmatic Breathing Exercise

b) Thoracic Expansion Exercise

c) lateral costal expansion technique

  1. Upper Limb (UL) & Lower Limb (LL) mobility exercise – 10 reps 1set

  2.  Ambulation

  • 4)Incentive spirometer 10 rep
  • 6 days per week , 1 week , twice a day.

 Inspiratory muscle training will be given as below:

1)The participants will be in sitting position.

2)The participants will be instructed to close their lips over the mouthpiece and inhale deeply, then continue to inhale and exhale without taking the device out of their mouth.

3)The participants will begin training with a light load, The training load is increased to 30% of the initial PImax.

4)The Intensity will be increased by 5–10% per week. The duration of the training will be 25–30min each time, 3set of 5repetation with 2min rest, twice a day, for Six days per week for at least one weeks.

研究设计

研究类型
Interventional

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Age 20-60 years.
  • Males and female who have undergone open abdominal surgery.
  • Patients vitally stable.
  • Able to follow command.
  • Pain less than 5 on Numerical pain rating scale.

排除标准

  • 1.Any cognitive impairment.
  • 2.History of prior abdominal surgery.
  • 3.Patients with underlying pulmonary condition (Tuberculosis, rib fracture) cardiac conditions (Recent MI, ejection fraction less than 30%).
  • 4.Patients on mechanical ventilator.
  • Patient with Pfannenstiel, lanz incisions.
  • Laproscopic surgery.

结局指标

主要结局

Respiratory Muscle Strength , Single Breath Count and Kinesiophobia

时间窗: Respiratory Muscle Strength 1 day before surgery and post operation day 2nd and 6th , Single Breath Count and Kinesiophobia will be asses on post operative day 2nd and 6th.

次要结局

未报告次要终点

研究者

发起方
Achal Lathi
申办方类型
Other [Charitable hospital]

研究点 (1)

Loading locations...

相似试验