ReflexologyNCT04416503
Effect of Reflexology on Diabetic Foot and Glycemic Control in Elderly Diabetic Individuals
A study testing Foot reflexology in people with Reflexology and Type 2 Diabetes, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
Background: Glycemic control can be difficult in the elderly with diabetes.Diabetic foot problems characterized by vascular and neuropathy are serious complications. The effectiveness of reflexology has been demonstrated to achieve glycemic control and manage diabetic foot problems. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Reflexology, Type 2 Diabetes, Older People
- What is being tested?
- Foot reflexology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2018to 1 Jul 2019
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Older than 65 years with type 2 diabetes
- No fractures or open wounds on both lower limbs
- No single or double sided amputation on the lower limbs.
Who cannot join
- Uncontrolled high blood pressure
- Acute infection with fever
- Acute surgical conditions
- Receiving dialysis treatment
- Being a verbal communication problem related to Alzheimer's or dementia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Reflexology on Ankle Brachial Index, Diabetic Peripheral Neuropathy, and Glycemic Control in Elderly Diabetic Individuals
Background: Glycemic control can be difficult in the elderly with diabetes.Diabetic foot problems characterized by vascular and neuropathy are serious complications. The effectiveness of reflexology has been demonstrated to achieve glycemic control and manage diabetic foot problems.
Objectives: To determine the effect of foot reflexology on ankle brachial index (ABI), diabetic peripheral neuropathy (DPN) and glycemic control in elderly diabetic individuals.
Read more
Design: A randomized clinical trial. Settings: An outpatient elderly health center in Turkey. Participants: 48 individuals aged 65 and over enrolled in the elderly health center were included.
Methods: The elderly were randomized into two groups (study, n=24; control,n=24). Foot reflexology was performed for 12 week in the study group, whereas the control group continued their routine treatment and follow-up. Both groups underwent a comprehensive foot examination for evaluating ABI and DPN at baseline and after 12 weeks; furthermore, glycemic control (glycated hemoglobin-HbA1c) was evaluated. An independent two-sample t-test was performed for pre- and post-test between-group comparisons; an effect size analysis was performed to determine the effect of intervention.
Read the detailed description
Background: Elderly individuals often refer to the health facility with the complications of diabetes as the first reason. Glycemic control can be quite difficult in elderly diabetic individuals compared to other age groups. Diabetic foot problems, leading to progressive problems from circulatory disorders and nervous loss to organ loss, constitute the most serious complications. Foot reflexology has been shown as a useful practice in the management of glycemic control and foot problems in diabetic individuals. Reflexology has been shown to have a positive effect on glycemic control and the management of diabetic foot problems. There are clinical trials of reflexology in Turkey for use in a variety of diseases or conditions, but there are no studies about diabetes or diabetes complications. Therefore, current research is a first in this regard. In this context, this study has been performed to determine the effect of foot reflexology on ABI, DPN, and glycemic control in elderly diabetic individuals.
Design: A randomized clinical trial. Settings: An outpatient elderly health center in Turkey. Participants: 48 individuals aged 65 and over enrolled in the elderly health center were included.
Measures: At baseline, subjective area was collected by participant information form. Glycemic control was evaluated with HbA1c. DPN and ABI assessment were performed by physical examination of the foot at baseline and three months later.
Methods: The elderly were randomized into two groups (study, n=24; control, n=24). Foot reflexology was performed for 12 week in the study group, whereas the control group continued their routine treatment and follow-up. Both groups underwent a comprehensive foot examination for evaluating ABI and DPN at baseline and after 12 weeks; furthermore, HbA1c was evaluated. An independent two-sample t-test was performed for pre- and post-test between-group comparisons; an effect size analysis was performed to determine the effect of intervention.
- Conditions
- Reflexology, Type 2 Diabetes, Older People
- Being tested
- Foot reflexology
- Keywords
- Aged, Ankle brachial index, Diabetic neuropathies, Glycated hemoglobin A, Musculoskeletal manipulations
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foot reflexologyOther
Foot reflexology was performed for 12 week in the study group,whereas the control group continued their routine treatment and follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Foot reflexology was performed for 12 week in the intervention group, whereas the control group continued their routine treatment and follow-up. Receives: Other: Foot reflexology |
| Control group | No intervention | Usual follow-up was done to the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Means of Ankle Brachial Index score
Vascular assessment test to assess peripheral circulation in the lower limbs. The measurement, obtained by dividing the highest ankle arterial pressure (posterior tibial or dorsalis pedis) on the same side by brachial pressure, was evaluated using a 5-10-MHz handheld Doppler device and a blood pressure cuff.
Measured: 3-month change
Means of Diabetic peripheral neuropathy score
Measurement parameter testing whether there is nerve damage due to diabetes by physical examination of the foot. The examination was determined using symptom and disability scores. Symptom scores included questions related to complaints experienced by patients, the location of the complaints, the presence of night or day symptoms, and how the symptoms relieved/subsided. Disability scores were determined with four parameters: vibration sensation (128 Hz tuning fork), pinprick sensation, achilles reflex and sensitivity to touch (Semmes-Weinstein nylon monofilaments 10 g).Participant responses and examination findings were scored according to a guideline and a neuropathy score was obtained for each participant.
Measured: 3-month change
HbA1c levels (%)
Blood test to evaluate glycemic control. Blood sample was collected in EDTA-coated tubes (2 mL of whole) from the participants.
Measured: 3-month change
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start1 Jul 2018
- Primary completion22 Apr 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ReflexologyStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Sponsor
- Investigators
- Süleyman ÖZSARI, PhD, DR, Study director, Bolu Provincial Health Directorate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04416503
- Sponsor's protocol ID
- AIBU-HSF-SCC-01
- Status last verified
- Jun 2020
- First submitted
- 26 May 2020
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cicek SC, Demir S, Yilmaz D, Yildiz S. Effect of reflexology on ankle brachial index, diabetic peripheral neuropathy, and glycemic control in older adults with diabetes: A randomized controlled trial. Complement Ther Clin Pract. 2021 Aug;44:101437. doi: 10.1016/j.ctcp.2021.101437. Epub 2021 Jul 4.
PubMed 34237668
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Reflexology on Ankle Brachial Index, Diabetic Peripheral Neuropathy, and Glycemic Control in Elderly Diabetic Individuals
- ClinicalTrials.gov ID
- NCT04416503
- Acronym / sponsor ID
- AIBU-HSF-SCC-01
- Conditions
- Reflexology, Type 2 Diabetes, Older People
- Keywords
- Aged, Ankle brachial index, Diabetic neuropathies, Glycated hemoglobin A, Musculoskeletal manipulations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 22 Apr 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 4 Jun 2020 (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.
Background: Glycemic control can be difficult in the elderly with diabetes.Diabetic foot problems characterized by vascular and neuropathy are serious complications. The effectiveness of reflexology has been demonstrated to achieve glycemic control and manage diabetic foot problems.
Objectives: To determine the effect of foot reflexology on ankle brachial index (ABI), diabetic peripheral neuropathy (DPN) and glycemic control in elderly diabetic individuals.
Design: A randomized clinical trial. Settings: An outpatient elderly health center in Turkey. Participants: 48 individuals aged 65 and over enrolled in the elderly health center were included.
Methods: The elderly were randomized into two groups (study, n=24; control,n=24). Foot reflexology was performed for 12 week in the study group, whereas the control group continued their routine treatment and follow-up. Both groups underwent a comprehensive foot examination for evaluating ABI and DPN at baseline and after 12 weeks; furthermore, glycemic control (glycated hemoglobin-HbA1c) was evaluated. An independent two-sample t-test was performed for pre- and post-test between-group comparisons; an effect size analysis was performed to determine the effect of intervention.
Detailed description
Background: Elderly individuals often refer to the health facility with the complications of diabetes as the first reason. Glycemic control can be quite difficult in elderly diabetic individuals compared to other age groups. Diabetic foot problems, leading to progressive problems from circulatory disorders and nervous loss to organ loss, constitute the most serious complications. Foot reflexology has been shown as a useful practice in the management of glycemic control and foot problems in diabetic individuals. Reflexology has been shown to have a positive effect on glycemic control and the management of diabetic foot problems. There are clinical trials of reflexology in Turkey for use in a variety of diseases or conditions, but there are no studies about diabetes or diabetes complications. Therefore, current research is a first in this regard. In this context, this study has been performed to determine the effect of foot reflexology on ABI, DPN, and glycemic control in elderly diabetic individuals.
Design: A randomized clinical trial. Settings: An outpatient elderly health center in Turkey. Participants: 48 individuals aged 65 and over enrolled in the elderly health center were included.
Measures: At baseline, subjective area was collected by participant information form. Glycemic control was evaluated with HbA1c. DPN and ABI assessment were performed by physical examination of the foot at baseline and three months later.
Methods: The elderly were randomized into two groups (study, n=24; control, n=24). Foot reflexology was performed for 12 week in the study group, whereas the control group continued their routine treatment and follow-up. Both groups underwent a comprehensive foot examination for evaluating ABI and DPN at baseline and after 12 weeks; furthermore, HbA1c was evaluated. An independent two-sample t-test was performed for pre- and post-test between-group comparisons; an effect size analysis was performed to determine the effect of intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Foot reflexologyFoot reflexology was performed for 12 week in the intervention group, whereas the control group continued their routine treatment and follow-up. |
| Control group | No intervention | –Usual follow-up was done to the control group. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Older than 65 years with type 2 diabetes
- No fractures or open wounds on both lower limbs
- No single or double sided amputation on the lower limbs.
Key exclusion criteria (5 listed)
- Uncontrolled high blood pressure
- Acute infection with fever
- Acute surgical conditions
- Receiving dialysis treatment
- Being a verbal communication problem related to Alzheimer's or dementia
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 |
|---|---|---|
| Foot reflexologyFoot reflexology was performed for 12 week in the study group,whereas the control group continued their routine treatment and follow-up. | Other | Intervention group |
Primary outcome
Means of Ankle Brachial Index score
Time frame: 3-month change
Vascular assessment test to assess peripheral circulation in the lower limbs. The measurement, obtained by dividing the highest ankle arterial pressure (posterior tibial or dorsalis pedis) on the same side by brachial pressure, was evaluated using a 5-10-MHz handheld Doppler device and a blood pressure cuff.
Means of Diabetic peripheral neuropathy score
Time frame: 3-month change
Measurement parameter testing whether there is nerve damage due to diabetes by physical examination of the foot. The examination was determined using symptom and disability scores. Symptom scores included questions related to complaints experienced by patients, the location of the complaints, the presence of night or day symptoms, and how the symptoms relieved/subsided. Disability scores were determined with four parameters: vibration sensation (128 Hz tuning fork), pinprick sensation, achilles reflex and sensitivity to touch (Semmes-Weinstein nylon monofilaments 10 g).Participant responses and examination findings were scored according to a guideline and a neuropathy score was obtained for each participant.
HbA1c levels (%)
Time frame: 3-month change
Blood test to evaluate glycemic control. Blood sample was collected in EDTA-coated tubes (2 mL of whole) from the participants.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Derived from this study: PubMed 34237668Cicek SC, Demir S, Yilmaz D, Yildiz S. Effect of reflexology on ankle brachial index, diabetic peripheral neuropathy, and glycemic control in older adults with diabetes: A randomized controlled trial. Complement Ther Clin Pract. 2021 Aug;44:101437. doi: 10.1016/j.ctcp.2021.101437. Epub 2021 Jul 4.
- Individual participant dataSharing planned: No
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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.
Süleyman ÖZSARI, PhD, DR study director
Bolu Provincial Health Directorate
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foot reflexology in people with Reflexology and Type 2 Diabetes, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
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 3 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: finished, as of the sponsor's last update on 4 Jun 2020. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Means of Ankle Brachial Index score (time frame: 3-month change). 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?
On the ClinicalTrials.gov record for NCT04416503, which also lists 1 linked publication.
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 4 Jun 2020.