The Impact of the Social Factors and Rehabilitation Progr... | NCT05383261

Studies
The Impact of the Social Factors and Rehabilitation Program to Address the Implications on Kidney Failure in Hail

NCT05383261

Sponsor

University of Hail

Status

Completed

Last Update Posted

May 10, 2023Actual

Enrollment

75Actual

Phase

Not provided

Conditions

Chronic Renal Disease

Interventions

exercise

Countries

Saudi Arabia

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

May 2023

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

Jul 5, 2022Actual

Primary Completion Date

Dec 2, 2022Actual

Completion Date

Dec 5, 2022Actual

First Submitted Date

May 16, 2022

First Submission Date that Met QC Criteria

May 16, 2022

First Posted Date

May 20, 2022Actual

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

May 8, 2023

Last Update Posted Date

May 10, 2023Actual

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

The aims of our study to evaluate the effect of social factors and medical rehabilitation program on kidney function and quality of life among chronic kidney disease patients.

Detailed Description

This study aims to evaluate the effect of social factors and medical rehabilitation program on kidney function and quality of life among chronic kidney disease patients.
Identify the health problems facing patients with kidney failure in Hail region.
Detect the reality of the problems facing patients with kidney failure in Hail region and ways to reduce them.
Identify the family, psychological, economic and social problems facing patients with kidney failure in Hail region.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

75Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
control		patients will take medical treatment only patients will receive medical treatment in addition to aerobic exercises	Other: exercise

Interventions

Name	Type	Description	Arm Group Labels	Other Names
exercise	Other	aerobic and resisted ex	control

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
6-minute walk test (6MWT). And Kidney Disease and Quality of Life (KDQOL™-36)	6-minute walk test (6MWT). And Kidney Disease and Quality of Life (KDQOL™-36)	after 6 week

Secondary Outcomes

Measure	Description	Time Frame
muscle power of lower limb	functional muscle test	after 6 week

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

participants with CKD stages (3 and 4) will be participated in this study, their ages ranged from 40 to 60 years. Both sexes will be included.

Participants should be: Saudi persons living in Hail City, married, both genders,

Exclusion Criteria:

(1) Severe chronic cardiac problems. (2) Chronic chest disease. (3) Chronic inflammatory orthopedic disorders and rheumatoid arthritis. (4) Mental impairments.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

participants with CKD stages (3 and 4) will be participated in this study, their ages ranged from 40 to 60 years. Both sexes will be included.

Participants should be: Saudi persons living in Hail City, married, both genders,

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Hail		Ha'il		2442	Saudi Arabia

Label	URL
hhhhhh	View source
hhhhh	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D051436	Renal Insufficiency, Chronic

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015444	Exercise

Ancestor Terms

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided