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临床试验/NCT06975397
NCT06975397已完成不适用

The Effect of Kinesio Taping on Reducing Diastasis Recti Abdominis Size in Postpartum Women

Proskura Patrycja1 个研究点 分布在 1 个国家目标入组 161 人开始时间: 2020年6月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
161
试验地点
1
主要终点
Diastasis Recti Index (DRI)

研究概览

简要总结

A three-arm parallel-group randomized controlled trial was conducted with 90 women aged 23-42 years, 6-8 weeks postpartum. Participants were randomly assigned to one of three groups: no kinesiotaping (control), placebo kinesiotaping (no tension), and kinesiotaping with 50% tension. All participants followed the same exercise program. The primary outcome measure was the Diastasis Recti Index (DRI), assessed via ultrasound at baseline, 4 weeks, and 8 weeks.

详细描述

This was a three-arm, parallel-group, randomised controlled trial with concealed allocation. The allocation of subjects to the experiment was arranged chronologically. Each woman meeting the inclusion criteria was consecutively qualified. None of the participants were aware of group allocations or the interventions used in each group according to CONSORT's diagram. Each subject was given the same exercises (instructor-led) and tested individually to maintain study blinding.

The clinical rationale for reducing DRA using Kinesio taping was evaluated in 90 females in the late postpartum period, defined as 6 - 8 weeks after childbirth.

The eligibility criteria for the study were:

  • aged between 25 and 45 years
  • first singleton pregnancy
  • natural childbirth
  • no medical contraindications for exercising and taping.

The exclusion criteria were:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Factorial
主要目的
Treatment
盲法
Single (Participant)

盲法说明

None of the participants were aware of group allocations or the interventions used in each group according to CONSORT's diagram. Each subject was given the same exercises (instructor-led) and tested individually to maintain study blinding.

入排标准

年龄范围
25 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •- aged between 25 and 45 years
  • •first singleton pregnancy
  • •natural childbirth
  • •no medical contraindications for exercising and taping.

排除标准

  • •- childbirth through cesarean section
  • •more than eight weeks from natural childbirth
  • •body mass index (BMI) over 35 kg/m2

研究组 & 干预措施

Group 1 - no taping - control group

Sham Comparator

The eligibility criteria for the study were:

  • aged between 25 and 45 years
  • first singleton pregnancy
  • natural childbirth
  • no medical contraindications for exercising and taping.

The exclusion criteria were:

  • childbirth through cesarean section
  • more than eight weeks from natural childbirth
  • body mass index (BMI) over 35 kg/m2

干预措施: EXERCISE TRAINING WITH OR WITHOUT MEDICATION (Other)

Group 2 - taping without tension - placebo group

Sham Comparator

The eligibility criteria for the study were:

  • aged between 25 and 45 years
  • first singleton pregnancy
  • natural childbirth
  • no medical contraindications for exercising and taping.

The exclusion criteria were:

  • childbirth through cesarean section
  • more than eight weeks from natural childbirth
  • body mass index (BMI) over 35 kg/m2

干预措施: EXERCISE TRAINING WITH OR WITHOUT MEDICATION (Other)

Group 2 - taping without tension - placebo group

Sham Comparator

The eligibility criteria for the study were:

  • aged between 25 and 45 years
  • first singleton pregnancy
  • natural childbirth
  • no medical contraindications for exercising and taping.

The exclusion criteria were:

  • childbirth through cesarean section
  • more than eight weeks from natural childbirth
  • body mass index (BMI) over 35 kg/m2

干预措施: kinesio taping (Other)

Group 3 - taping at 50 % tension - tape group

Active Comparator

The eligibility criteria for the study were:

  • aged between 25 and 45 years
  • first singleton pregnancy
  • natural childbirth
  • no medical contraindications for exercising and taping.

The exclusion criteria were:

  • childbirth through cesarean section
  • more than eight weeks from natural childbirth
  • body mass index (BMI) over 35 kg/m2

干预措施: EXERCISE TRAINING WITH OR WITHOUT MEDICATION (Other)

Group 3 - taping at 50 % tension - tape group

Active Comparator

The eligibility criteria for the study were:

  • aged between 25 and 45 years
  • first singleton pregnancy
  • natural childbirth
  • no medical contraindications for exercising and taping.

The exclusion criteria were:

  • childbirth through cesarean section
  • more than eight weeks from natural childbirth
  • body mass index (BMI) over 35 kg/m2

干预措施: kinesio taping (Other)

结局指标

主要结局

Diastasis Recti Index (DRI)

时间窗: The effectiveness of Kinesio taping was assessed based on intergroup differences in the initial measurement values (DRI1) taken before the start of the project, the second measurement after 4 weeks (DRI2), and the third measurement after 8 weeks (DRI3).

outcome: Diastasis Recti Index (DRI) was computed in order to normalize the ultrasound examination results. The DRA width was divided by waist circumference and multiplied by 100% to determine the changes in diastasis width at the navel line (DRIn), above the navel (DRIan), and under the navel (DRIun): DRI \[%\]=DRAw\[cm\]/(waist circumference \[cm\] )\*100% where * DRAw is the diastasis recti abdominis width at a given measurement line: at the navel, above the navel, and under the navel (respectively) * waist circumference was measured at the navel line in a given session.

次要结局

未报告次要终点

研究者

发起方
Proskura Patrycja
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Proskura Patrycja

dr

Wroclaw University of Health and Sport Sciences

研究点 (1)

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