Physical PerformanceNCT05399823
The Effect of Taping in Addition to Self-stretching Exercise in the Elderly People With Hyperkyphosis
A study testing Exercise in people with Physical Performance, run by Eastern Mediterranean University at 1 site in Cyprus.
Trial summary
Aim: The aim of the study is to investigate the effectiveness of kinesio taping and sham taping in addition to self-stretching exercise on hyperkyphosis angle, neck pain and quality of life in elderly individuals with hyperkyphosis. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Performance
- What is being tested?
- Exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteCyprus
- Study dates
- 14 Jan 2022to 30 Aug 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 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteer female and male individuals between the aged of 60-85 years,
- Kyphosis angle is greater than 56 degrees in women and 62 degrees in men,
- Individuals who have not physiotherapy in the last 6 months,
- Individuals who have not phsical activity in the last 6 months.
Who cannot join
- Individuals with any thoracic scoliosis and Scheuermann's disease,
- Individuals who having a kinesio tape allergy or developing an allergy while working.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Taping in Addition to Self-stretching Exercise on Thoracic Kyphosis Angle, Neck Pain and Quality of Life in Elderly People With Hyperkyphosis
Aim: The aim of the study is to investigate the effectiveness of kinesio taping and sham taping in addition to self-stretching exercise on hyperkyphosis angle, neck pain and quality of life in elderly individuals with hyperkyphosis.
Method: 60 elderly individuals with hyperkyphosis aged 60-85 years will be included in the study. Subjects will be divided inti three groups. Kinesio taping, sham taping and self-stretching exercise. The kinesio taping group will be given kinesio taping in addition to self stretching exercises. The second sham taping group will be given sham kinesio taping in addition to self stretching exercises. The third self-stretching group will be given a program consisting of stretching exercises for pectoral, erector spinae, latismus dorsi, multifidus, rhomboid and trapezius muscles. Individuals will be asked to do these exercises on their own for 15-20 minutes at home or in the office every day for four weeks. Before and after the study, the subjects will be test for the kyphosis angle will be evaluated with a flexible ruler and Scoliosis Research Society Outcome questionnaire (SRS22) will be used to evaluate spinal curvatures.The Neck Disability Questionnaire will be used to evaluate neck pain. The occiput-neck distance and mini mental test will be used in this srudy.
- Conditions
- Physical Performance
- Being tested
- Exercise
- Keywords
- Exercise, Kinesiotape, Kyphosis, Elderly
- Medical subject headings
- Motor Activity, Kyphosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Strecthing exercises will given for 15-20 minutes everyday for four weeks
| Study group | Role | What they receive |
|---|---|---|
| Self Stretching and Kinesio Taping Group | Experimental | Kinesio taping in addition to self stretching exercises will be given for 15-20 minutes at home or in the office every day for four weeks. Receives: Other: Exercise |
| Self Stretching and Sham Taping Group | Sham comparator | Sham kinesio taping in addition to self stretching exercises will be given for 15-20 minutes at home or in the office every day for four weeks. Receives: Other: Exercise |
| Self Stretching Group | Active comparator | A program consisting of stretching exercises for pectoral, erector spinae, latismus dorsi, multifidus, rhomboid and trapezius muscles will be given for 15-20 minutes at home or in the office every day for four weeks. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the kyphosis angle to be evaluated by a flexible ruler
C7 and T12 vertebrae will be taken as reference in the measurement of the kyphosis angle. The Q angle is calculated by measuring the distances between the points taken as criteria.
Measured: Baseline and at the end of 4 weeks
Secondary outcomes (1)
Chane in the spinal curvature to be evaluated by Scoliosis Research Society Outcome Questionnaire (SRS22)
The SRS-22 scale is a scale developed by the Scoliosis Research Society to evaluate all spinal curvatures. The scale consists of 22 questions and five subgroups. Subgroups; pain, body image, spine functions, mental health and satisfaction with treatment. Scores are calculated by assigning an answer value to all 22 questions within a five-point indicator chart.
Measured: Baseline and at the end of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start14 Jan 2022
- Primary completion28 Aug 2023 (estimated)
- Study completion30 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical PerformanceStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özge Gökalp, Eastern Mediterranean University
- Investigators
- Inci Yuksek, Study chair, Eastern Mediterranean University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05399823
- Sponsor's protocol ID
- 2020/0111
- Status last verified
- Aug 2023
- First submitted
- 27 May 2022
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Taping in Addition to Self-stretching Exercise on Thoracic Kyphosis Angle, Neck Pain and Quality of Life in Elderly People With Hyperkyphosis
- ClinicalTrials.gov ID
- NCT05399823
- Acronym / sponsor ID
- 2020/0111
- Conditions
- Physical Performance
- Keywords
- Exercise, Kinesiotape, Kyphosis, Elderly
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- 14 Jan 2022 (actual)
- Primary completion
- 28 Aug 2023 (estimated)
- Study completion
- 30 Aug 2023 (estimated)
- First posted
- 1 Jun 2022 (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.
Aim: The aim of the study is to investigate the effectiveness of kinesio taping and sham taping in addition to self-stretching exercise on hyperkyphosis angle, neck pain and quality of life in elderly individuals with hyperkyphosis.
Method: 60 elderly individuals with hyperkyphosis aged 60-85 years will be included in the study. Subjects will be divided inti three groups. Kinesio taping, sham taping and self-stretching exercise. The kinesio taping group will be given kinesio taping in addition to self stretching exercises. The second sham taping group will be given sham kinesio taping in addition to self stretching exercises. The third self-stretching group will be given a program consisting of stretching exercises for pectoral, erector spinae, latismus dorsi, multifidus, rhomboid and trapezius muscles. Individuals will be asked to do these exercises on their own for 15-20 minutes at home or in the office every day for four weeks. Before and after the study, the subjects will be test for the kyphosis angle will be evaluated with a flexible ruler and Scoliosis Research Society Outcome questionnaire (SRS22) will be used to evaluate spinal curvatures.The Neck Disability Questionnaire will be used to evaluate neck pain. The occiput-neck distance and mini mental test will be used in this srudy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Self Stretching and Kinesio Taping Group | Experimental | Other: ExerciseKinesio taping in addition to self stretching exercises will be given for 15-20 minutes at home or in the office every day for four weeks. |
| Self Stretching and Sham Taping Group | Sham comparator | Other: ExerciseSham kinesio taping in addition to self stretching exercises will be given for 15-20 minutes at home or in the office every day for four weeks. |
| Self Stretching Group | Active comparator | Other: ExerciseA program consisting of stretching exercises for pectoral, erector spinae, latismus dorsi, multifidus, rhomboid and trapezius muscles will be given for 15-20 minutes at home or in the office every day for four weeks. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Volunteer female and male individuals between the aged of 60-85 years,
- Kyphosis angle is greater than 56 degrees in women and 62 degrees in men,
- Individuals who have not physiotherapy in the last 6 months,
- Individuals who have not phsical activity in the last 6 months.
Key exclusion criteria (2 listed)
- Individuals with any thoracic scoliosis and Scheuermann's disease,
- Individuals who having a kinesio tape allergy or developing an allergy while working.
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 |
|---|---|---|
| ExerciseStrecthing exercises will given for 15-20 minutes everyday for four weeks | Other | Self Stretching Group, Self Stretching and Kinesio Taping Group, Self Stretching and Sham Taping Group |
Primary outcome
Change in the kyphosis angle to be evaluated by a flexible ruler
Time frame: Baseline and at the end of 4 weeks
C7 and T12 vertebrae will be taken as reference in the measurement of the kyphosis angle. The Q angle is calculated by measuring the distances between the points taken as criteria.
1 secondary outcome
Chane in the spinal curvature to be evaluated by Scoliosis Research Society Outcome Questionnaire (SRS22)
Time frame: Baseline and at the end of 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
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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.
Inci Yuksek study chair
Eastern Mediterranean 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 Exercise in people with Physical Performance, run by Eastern Mediterranean University at 1 site in Cyprus.
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 4 inclusion and 2 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 29 Aug 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 Cyprus. 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the kyphosis angle to be evaluated by a flexible ruler (time frame: Baseline and at the end of 4 weeks). 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 29 Aug 2023.