Breast CancerNCT05726643
Effect of Kinesiotaping Augmented By Resistive Exercise on Fatigue, Physical Strength, Quality of Life in Breast Cancer Survivors
A study testing resistive training and kinesiotaping in people with Breast Cancer and Fatigue, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Fatigue, Quality of Life
- What is being tested?
- resistive training and kinesiotaping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2023to 20 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Respiratory or heart problems affecting mobility
- Marked skeletal deformity.
- Visual system affection.
- Cognition problems.
- Previous surgeries at their back and/or lower limbs.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Breast Cancer, Fatigue, Quality of Life
- Being tested
- resistive training, kinesiotaping
- Medical subject headings
- Breast Neoplasms, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resistive trainingOther
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.
kinesiotapingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| resistive training group | Active comparator | consists of 20 patients who will receive resistive training for 2times per week for 12 weeks Receives: 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. Receives: Other: resistive training; Other: kinesiotaping |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: at baseline and after 12 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2023
- Study start20 Feb 2023 (estimated)
- Primary completion20 May 2023 (estimated)
- Study completion20 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Mos'ad Ebrahim Rmdan, Cairo University
- Investigators
- Alaa Negm, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05726643
- Sponsor's protocol ID
- Alaa_Negm_MSc_2023
- Status last verified
- Feb 2023
- First submitted
- 3 Feb 2023
- Last updated
- 14 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Kinesiotaping Augmented By Resistive Exercise on Fatigue, Physical Strength, Quality of Life in Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT05726643
- Acronym / sponsor ID
- Alaa_Negm_MSc_2023
- Conditions
- Breast Cancer, Fatigue, Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Feb 2023 (estimated)
- Primary completion
- 20 May 2023 (estimated)
- Study completion
- 20 Jun 2023 (estimated)
- First posted
- 14 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| resistive training group | Active comparator | Other: resistive trainingconsists of 20 patients who will receive resistive training for 2times per week for 12 weeks |
| kinesotaping group | Experimental | Other: resistive training, Other: kinesiotapingconsists of 20 patients who will receive resistive training program augmented by kinesotaping, 2 times /week for 12 weeks. |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- Respiratory or heart problems affecting mobility
- Marked skeletal deformity.
- Visual system affection.
- Cognition problems.
- Previous surgeries at their back and/or lower limbs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| resistive training5 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 | kinesotaping group, resistive training group |
| kinesiotapingTape 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. | Other | kinesotaping group |
Primary outcome
Assessing the change in fatigue
Time frame: at baseline and after 12 weeks of intervention
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
Time frame: at baseline and after 12 weeks of intervention
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
Time frame: at baseline and after 12 weeks of intervention
Muscle strength will be assessed using dynamometer at starting and after 12 weeks of the treatment course.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alaa Negm principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing resistive training and kinesiotaping in people with Breast Cancer and Fatigue, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alaa Negm (+201050366830, ptrservices2022@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing the change in fatigue (time frame: at baseline and after 12 weeks of intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2023.