Physical Exercise and Diet Management in Vitamin D Deficient Females

NCT ID: NCT06114381

Last Updated: 2023-11-02

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2023-06-30

Brief Summary

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The purpose of this study was to determine if home based physical exercises protocol and Diet management has an effect on functional performance and depression level related to vitamin D deficiency in females.

Detailed Description

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This is a randomized controlled trial to study the effect of home based physical exercises in comparison to Diet management, sun exposure and vitamin D supplements on functional performance and depression level in females with vitamin D deficiency.

Conditions

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Vitamin D Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Home Based Physical Exercise

This group composed of 30 participants who will receive full body physical exercise 6 days per week in addition to sun exposure as well as their vitamin D supplement for 6 weeks.

Group Type EXPERIMENTAL

Home Based Physical Exercise

Intervention Type OTHER

Home Exercise protocol consists of one hour divided to 3 minutes warm up",9 minutes' full body (lower limbs, abdomen, back and upper limbs) exercise composed of (aerobic and strengthening) and 3 minutes cool down 4 times per day and 15 minutes for each session 6 days with one day recovery and, with every day follow up with each patient to ensure they did the whole sets and instructed them the ways to each exercise, The total duration was 36 sessions (6 weeks) for each patient. Daily communication with all subjects through sending mobile messages 3 times every day. The message was to remind the participants and confirmation of their response.

Vitamin D3 Supplements

Intervention Type DIETARY_SUPPLEMENT

Vitamin D3 supplement (400mg) once daily.

Sun Exposure

Intervention Type BEHAVIORAL

Patients regular exposure to sun once a day 30 minutes of sun exposure, between 10 a.m. and 4 p.m. daily. Exposure to the face, arms, hands, and legs without sunscreen

Diet management group

This group composed of 30 participants who will receive dietary management and sun exposure as well as their vitamin D supplement for 6 weeks.

Group Type EXPERIMENTAL

Vitamin D3 Supplements

Intervention Type DIETARY_SUPPLEMENT

Vitamin D3 supplement (400mg) once daily.

Diet Management

Intervention Type OTHER

Patients receive weekly diet program contains dietary sources of Vitamin D such as yolk eggs, tuna and milk.

Sun Exposure

Intervention Type BEHAVIORAL

Patients regular exposure to sun once a day 30 minutes of sun exposure, between 10 a.m. and 4 p.m. daily. Exposure to the face, arms, hands, and legs without sunscreen

Sun Exposure and supplements

This group composed of 30 participants who will receive only sun exposure as well as their vitamin D supplement for 6 weeks.

Group Type EXPERIMENTAL

Vitamin D3 Supplements

Intervention Type DIETARY_SUPPLEMENT

Vitamin D3 supplement (400mg) once daily.

Sun Exposure

Intervention Type BEHAVIORAL

Patients regular exposure to sun once a day 30 minutes of sun exposure, between 10 a.m. and 4 p.m. daily. Exposure to the face, arms, hands, and legs without sunscreen

Control group

This group composed of 30 participants who didn't receive any intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Home Based Physical Exercise

Home Exercise protocol consists of one hour divided to 3 minutes warm up",9 minutes' full body (lower limbs, abdomen, back and upper limbs) exercise composed of (aerobic and strengthening) and 3 minutes cool down 4 times per day and 15 minutes for each session 6 days with one day recovery and, with every day follow up with each patient to ensure they did the whole sets and instructed them the ways to each exercise, The total duration was 36 sessions (6 weeks) for each patient. Daily communication with all subjects through sending mobile messages 3 times every day. The message was to remind the participants and confirmation of their response.

Intervention Type OTHER

Vitamin D3 Supplements

Vitamin D3 supplement (400mg) once daily.

Intervention Type DIETARY_SUPPLEMENT

Diet Management

Patients receive weekly diet program contains dietary sources of Vitamin D such as yolk eggs, tuna and milk.

Intervention Type OTHER

Sun Exposure

Patients regular exposure to sun once a day 30 minutes of sun exposure, between 10 a.m. and 4 p.m. daily. Exposure to the face, arms, hands, and legs without sunscreen

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Subjects whose age ranged from 19-25 years.
* All participants have pre laboratory results with vitamin D deficiency less than 25 nmol/L and have been lasted for 6 months
* All participated subjects were female studying at Al-Jouf university, Al- Qurrayyat-Female Branch.

Exclusion Criteria

* Chronic illness, liver, renal endocrine or autoimmune diseases.
* Patients who suffered from any cardiopulmonary diseases.
* History of fractures or any neuro-musculoskeletal disorders.
Minimum Eligible Age

19 Years

Maximum Eligible Age

25 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Badr University

OTHER

Sponsor Role lead

Responsible Party

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Mina Atef Georgui Elias

Lecturer, Department of Physical Therapy for Internal Medicine and Geriatrics, Faculty of Physical Therapy, Badr University in Cairo, Egypt.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wael OA Abd El-Khalek, Dr.

Role: STUDY_CHAIR

Dept of Basic Sciences, Faculty of PT, BUC, Cairo, Egypt.

Doaa Saeed, Dr.

Role: STUDY_CHAIR

Dept of PT for women's health, Faculty of PT, BUC, Cairo, Egypt.

Mina AG Elias, Dr.

Role: STUDY_CHAIR

Dept of PT for Internal Medicine & Geriatrics, Faculty of PT, BUC, Cairo, Egypt.

Heba A Bahey El-Deen, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Dept of PT & Health Rehabilitation, College of Applied Medical Sciences, Jouf University, KSA.

Locations

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College of Applied Medical Sciences, Jouf University, Kingdom of Saudi Arabia

Jazan, Al Jawf Region, Saudi Arabia

Site Status

Countries

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Saudi Arabia

Other Identifiers

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BUC-IACUC-231015-43

Identifier Type: -

Identifier Source: org_study_id

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