search
Back to results

Effect of Kinesiotaping Augmented By Resistive Exercise on Fatigue, Physical Strength, Quality of Life in Breast Cancer Survivors

Primary Purpose

Breast Cancer, Fatigue, Quality of Life

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
resistive training
kinesiotaping
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

40 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Patient's age will range from 40- 55 years. Their body mass index (BMI) will be from 25 to 29,9 Kg/m2. They suffer from breast cancer. They will receive chemotherapy within previous 3 months. They complain from fatigue, deterioration in their daily living activity (ADL) and feeling of weakness in their muscles. Exclusion Criteria: Respiratory or heart problems affecting mobility Marked skeletal deformity. Visual system affection. Cognition problems. Previous surgeries at their back and/or lower limbs.

Sites / Locations

  • Outpatient clinic faculty of physica therapy cairo university

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

resistive training group

kinesotaping group

Arm Description

consists of 20 patients who will receive resistive training for 2times per week for 12 weeks

consists of 20 patients who will receive resistive training program augmented by kinesotaping, 2 times /week for 12 weeks.

Outcomes

Primary Outcome Measures

Assessing the change in fatigue
The Fatigue Severity Scale is a 14-item will be used to measure the severity, frequency and diurnal variation of fatigue, as well as its perceived interference with quality of life.
Assessing the change in quality of life
By using 36-Item Short Form (SF-36) health survey will be used to assess QoL. The SF-36 questionnaire includes eight multiple-item subscales that evaluate physical function, social functioning, role limitations due to physical problems and role limitations due to emotional problems, mental health, vitality, pain and general health perception. Total score on each SF-36 subscale ranges between 0 and 100. Greater score indicates better QoL
Assessing the change in muscle strength
Muscle strength will be assessed using dynamometer at starting and after 12 weeks of the treatment course.

Secondary Outcome Measures

Full Information

First Posted
February 3, 2023
Last Updated
February 3, 2023
Sponsor
Cairo University
search

1. Study Identification

Unique Protocol Identification Number
NCT05726643
Brief Title
Effect of Kinesiotaping Augmented By Resistive Exercise on Fatigue, Physical Strength, Quality of Life in Breast Cancer Survivors
Official Title
Effect of Kinesiotaping Augmented By Resistive Exercise on Fatigue, Physical Strength, Quality of Life in Breast Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 20, 2023 (Anticipated)
Primary Completion Date
May 20, 2023 (Anticipated)
Study Completion Date
June 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of the study will be to investigate the effect of kinesotaping augmented by resistive exercise on fatigue, muscle strength, and QoL in breast cancer survivors.
Detailed Description
The present study will provide an evidence base to women's health care providers about the effect of strength training augmented by kinesotaping on fatigue, QoL and muscle strength in breast cancer women compared to strength training alone

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Fatigue, Quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
resistive training group
Arm Type
Active Comparator
Arm Description
consists of 20 patients who will receive resistive training for 2times per week for 12 weeks
Arm Title
kinesotaping group
Arm Type
Experimental
Arm Description
consists of 20 patients who will receive resistive training program augmented by kinesotaping, 2 times /week for 12 weeks.
Intervention Type
Other
Intervention Name(s)
resistive training
Intervention Description
5 minutes warming up exercise for various parts of the body as moderately energetic walking. 5 to 10 minutes stretching exercise for (pectorals major, hamstring, hip flexors, and calf muscles) with each static stretch held for at least 20 seconds in first week and then 30 seconds for the remaining 5 weeks and this will be repeated about four times. 10 to 15 minutes strengthening exercise by using weights for lower limbs (knee extensors, hip abductors, and hip extensors) at first session for each patient. Ten repetitions maximum (10 RM) will be determined, which is the maximal weight can be lifted through the entire range of motion 10 times.
Intervention Type
Other
Intervention Name(s)
kinesiotaping
Intervention Description
Tape will be applied to each participant in the treatment group for the sartorius, rectus femoris, hamstrings, tibialis anterior, fibularis brevis, and the patella bilaterally using strips of the standard 2-inch Kinesio Tex Tape. The first and last inch of each strip will be applied without tension. The length of the strip will be applied with a 20%- 25% stretch and downward pressure to the insertion. Each of the sartorius, rectus femoris, hamstrings, tibialis anterior and fibularis brevis tapings used an I-strip. AY strip will be utilized for the patellar taping.
Primary Outcome Measure Information:
Title
Assessing the change in fatigue
Description
The Fatigue Severity Scale is a 14-item will be used to measure the severity, frequency and diurnal variation of fatigue, as well as its perceived interference with quality of life.
Time Frame
at baseline and after 12 weeks of intervention
Title
Assessing the change in quality of life
Description
By using 36-Item Short Form (SF-36) health survey will be used to assess QoL. The SF-36 questionnaire includes eight multiple-item subscales that evaluate physical function, social functioning, role limitations due to physical problems and role limitations due to emotional problems, mental health, vitality, pain and general health perception. Total score on each SF-36 subscale ranges between 0 and 100. Greater score indicates better QoL
Time Frame
at baseline and after 12 weeks of intervention
Title
Assessing the change in muscle strength
Description
Muscle strength will be assessed using dynamometer at starting and after 12 weeks of the treatment course.
Time Frame
at baseline and after 12 weeks of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patient's age will range from 40- 55 years. Their body mass index (BMI) will be from 25 to 29,9 Kg/m2. They suffer from breast cancer. They will receive chemotherapy within previous 3 months. They complain from fatigue, deterioration in their daily living activity (ADL) and feeling of weakness in their muscles. Exclusion Criteria: Respiratory or heart problems affecting mobility Marked skeletal deformity. Visual system affection. Cognition problems. Previous surgeries at their back and/or lower limbs.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alaa Negm
Phone
+201050366830
Email
ptrservices2022@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alaa Negm
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Outpatient clinic faculty of physica therapy cairo university
City
Dokki
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Effect of Kinesiotaping Augmented By Resistive Exercise on Fatigue, Physical Strength, Quality of Life in Breast Cancer Survivors

We'll reach out to this number within 24 hrs