Effect of Reflexology on Diabetic Foot and Glycemic Control in Elderly Diabetic Individuals
NCT ID: NCT04416503
Last Updated: 2020-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
48 participants
INTERVENTIONAL
2018-07-01
2019-07-01
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Intervention group
Foot reflexology was performed for 12 week in the intervention group, whereas the control group continued their routine treatment and follow-up.
Foot reflexology
Foot reflexology was performed for 12 week in the study group,whereas the control group continued their routine treatment and follow-up.
Control group
Usual follow-up was done to the control group.
No interventions assigned to this group
Interventions
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Foot reflexology
Foot reflexology was performed for 12 week in the study group,whereas the control group continued their routine treatment and follow-up.
Eligibility Criteria
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Inclusion Criteria
* No fractures or open wounds on both lower limbs
* No single or double sided amputation on the lower limbs.
Exclusion Criteria
* Acute infection with fever
* Acute surgical conditions
* Receiving dialysis treatment
* Being a verbal communication problem related to Alzheimer's or dementia
65 Years
ALL
No
Sponsors
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The Scientific and Technological Research Council of Turkey
OTHER
Abant Izzet Baysal University
OTHER
Responsible Party
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Principal Investigators
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Süleyman ÖZSARI, PhD, DR
Role: STUDY_DIRECTOR
Bolu Provincial Health Directorate
Locations
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Bolu Elderly Health Center
Bolu, , Turkey (Türkiye)
Countries
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References
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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.
Other Identifiers
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AIBU-HSF-SCC-01
Identifier Type: -
Identifier Source: org_study_id
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