NCT05726643

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 14, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

February 20, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2023

Completed
Last Updated

February 14, 2023

Status Verified

February 1, 2023

Enrollment Period

3 months

First QC Date

February 3, 2023

Last Update Submit

February 3, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

resistive training group

ACTIVE COMPARATOR

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

Other: resistive training

kinesotaping group

EXPERIMENTAL

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

Other: resistive trainingOther: kinesiotaping

Interventions

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.

kinesotaping groupresistive training group

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.

kinesotaping group

Eligibility Criteria

Age40 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Respiratory or heart problems affecting mobility
  • Marked skeletal deformity.
  • Visual system affection.
  • Cognition problems.
  • Previous surgeries at their back and/or lower limbs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Outpatient clinic faculty of physica therapy cairo university

Dokki, Egypt

Location

MeSH Terms

Conditions

Breast NeoplasmsFatigue

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Alaa Negm

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 3, 2023

First Posted

February 14, 2023

Study Start

February 20, 2023

Primary Completion

May 20, 2023

Study Completion

June 20, 2023

Last Updated

February 14, 2023

Record last verified: 2023-02

Locations