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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Quality of Life; Breast Cancer; Fatigue
• Intervention / Treatment: Other: resistive training; Other: kinesiotaping

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

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alaa Negm; Phone Number: +201050366830; Email: ptrservices2022@gmail.com

Study Locations

• Egypt
  • Dokki, Egypt
    • Outpatient clinic faculty of physica therapy cairo university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: resistive training group; consists of 20 patients who will receive resistive training for 2times per week for 12 weeks	Other: resistive training; 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.
EXPERIMENTAL: kinesotaping group; consists of 20 patients who will receive resistive training program augmented by kinesotaping, 2 times /week for 12 weeks.	Other: resistive training; 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.; Other: kinesiotaping; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at baseline and after 12 weeks of intervention
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	at baseline and after 12 weeks of intervention
Assessing the change in muscle strength	Muscle strength will be assessed using dynamometer at starting and after 12 weeks of the treatment course.	at baseline and after 12 weeks of intervention

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Alaa Negm, Cairo University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 20, 2023
• Primary Completion (ANTICIPATED): May 20, 2023
• Study Completion (ANTICIPATED): June 20, 2023

Study Registration Dates

• First Submitted: February 3, 2023
• First Submitted That Met QC Criteria: February 3, 2023
• First Posted (ESTIMATE): February 14, 2023

Study Record Updates

• Last Update Posted (ESTIMATE): February 14, 2023
• Last Update Submitted That Met QC Criteria: February 3, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Fatigue
• Other Study ID Numbers: Alaa_Negm_MSc_2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No