Reflexology and Quality of Life | NCT03280524

Studies
Reflexology and Quality of Life

NCT03280524

Sponsor

Universidade do Vale do Sapucai

Status

Completed

Last Update Posted

Feb 28, 2018Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Diabetic Foot

Interventions

reflexology
self-care guidelines with feet

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2016Actual

Primary Completion Date

Mar 2017Actual

Completion Date

May 2017Actual

First Submitted Date

Sep 7, 2017

First Submission Date that Met QC Criteria

Sep 11, 2017

First Posted Date

Sep 12, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 27, 2018

Last Update Posted Date

Feb 28, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Beatriz Bertolaccini Martínez, Professor, Universidade do Vale do SapucaiPrincipal Investigator

Lead Sponsor

Universidade do Vale do SapucaiOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a randomized, controlled and blind clinical trial with 60 type 2 diabetes patients divided into 2 groups of 30 patients each, Control Group (CG) and Treatment Group (TG). The TG will receive self-care guidelines with feet and 12 sessions of foot reflexology, while the CG will only receive the guideline.

Detailed Description

The purpose of this study is to evaluate the effects of reflexology on the quality of life and functional capacity of patients at risk for diabetic neuropathy. This is a randomized, controlled and blind clinical trial with type 2 diabetes patients. The eligibility criteria are 10 years or more of diagnosis of diabetes mellitus, between the ages of 50 to 75 years, both sexes, and registered in the Primary Health Care Unit of São João or in the Diabetes Education Center in Minas Gerais state, Brazil. As exclusion criteria, it will be considered the presence of ulcers in the feet, amputations of the lower limbs, deficits in cognitive abilities, and previous treatment using reflexology. For the calculation of the sample size, a pilot test will be conducted with 8 diabetic patients. It will be used the statistical software Biostat® 5.3. The sample found was of 60 patients who were divided into 2 groups of 30 patients each, Control Group (CG) and Treatment Group (TG). The TG will receive self-care guidelines with feet and 12 sessions of foot reflexology, while the CG will only receive the guideline. For the evaluations, it will be applied the instrument for quality of life (SF-36) and for functional capacity, the Stanford Health Assessment Questionnaire. This research will follow the standards set by resolution 466/12 of the National Health Council, for research with human beings and will be conducted in accordance with the ethical recommendations of the Declaration of Helsinki.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control Group	Placebo Comparator	Control Group will receive self-care guidelines with feet	Other: self-care guidelines with feet
Treatment Group	Experimental	Treatment will receive self-care guidelines with feet and 12 sessions of foot reflexology	Other: reflexology Other: self-care guidelines with feet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
reflexology	Other		Treatment Group	massage
self-care guidelines with feet

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Quality of Life Questionnaire SF-36	measure of quality of life	An average of 1 year

Secondary Outcomes

Not provided

Other Outcomes

Measure	Description	Time Frame
Stanford Health Assessment Questionnaire	measure of functional capacity	An average of 1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

10 years or more of diagnosis of diabetes mellitus, between the ages of 50 to 75 years, both sexes, and registered in the Primary Health Care Unit of São João or in the Diabetes Education Center in Minas Gerais state, Brazil.

Exclusion Criteria:

presence of ulcers in the feet, amputations of the lower limbs, deficits in cognitive abilities, and previous treatment using reflexology

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Beatriz Ms Martínez, doctor	Universidade do Vale do Sapucai	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Diabetes Education Center		Pouso Alegre	Minas Gerais	37550000	Brazil

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18820804	Background	Aguiar CC, Vieira AP, Carvalho AF, Montenegro-Junior RM. [Assessment instruments for a Health-Related Quality of Life in diabetes mellitus]. Arq Bras Endocrinol Metabol. 2008 Aug;52(6):931-9. doi: 10.1590/s0004-27302008000600004. Portuguese.
23393665	Background	Kaul K, Tarr JM, Ahmad SI, Kohner EM, Chibber R. Introduction to diabetes mellitus. Adv Exp Med Biol. 2012;771:1-11. doi: 10.1007/978-1-4614-5441-0_1.

ID	Term
D017719	Diabetic Foot
D003920	Diabetes Mellitus

ID	Term
D003925	Diabetic Angiopathies
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D016523	Foot Ulcer

ID	Term
D026201	Musculoskeletal Manipulations
D008405	Massage
D004522	Educational Status

ID	Term
D000529	Complementary Therapies
D013812	Therapeutics
D026741	Physical Therapy Modalities
D012046	Rehabilitation