Physical Exercise and Diet Management in Vitamin D Deficient Females

Study Overview
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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.

Official Title
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Impact of Home Based Physical Exercise and Diet Management on Functional Performance and Depression Among Vitamin D Deficient Females

Conditions
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Vitamin D Deficiency

Intervention / Treatment
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* Other: Home Based Physical Exercise
* Dietary Supplement: Vitamin D3 Supplements
* Other: Diet Management
* Behavioral: Sun Exposure


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home Based Physical Exercise<br>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. | Other: Home Based Physical Exercise<br>* 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.<br>Dietary Supplement: Vitamin D3 Supplements<br>* Vitamin D3 supplement (400mg) once daily.<br>Behavioral: Sun Exposure<br>* 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<br>|
| Experimental: Diet management group<br>This group composed of 30 participants who will receive dietary management and sun exposure as well as their vitamin D supplement for 6 weeks. | Dietary Supplement: Vitamin D3 Supplements<br>* Vitamin D3 supplement (400mg) once daily.<br>Other: Diet Management<br>* Patients receive weekly diet program contains dietary sources of Vitamin D such as yolk eggs, tuna and milk.<br>Behavioral: Sun Exposure<br>* 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<br>|
| Experimental: Sun Exposure and supplements<br>This group composed of 30 participants who will receive only sun exposure as well as their vitamin D supplement for 6 weeks. | Dietary Supplement: Vitamin D3 Supplements<br>* Vitamin D3 supplement (400mg) once daily.<br>Behavioral: Sun Exposure<br>* 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<br>|
| No Intervention: Control group<br>This group composed of 30 participants who didn't receive any intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vitamin D3 blood test | Measuring of Vitamin D3 in Blood through lab test | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Depression Rating Scale (HAMD) | Depression questionnaire The HDRS (also known as the Ham-D) is the most widely used clinician-administered depression assessment scale. The original version contains 17 items (HDRS 17) pertaining to symptoms of depression experienced. The patients were brought and explained to them the method of the questionnaire, and then they answered all 17 questions and the numbers for each patient were collected and written down. | 6 weeks | 
| 6 Minutes Walk Test | Measuring the distance patient walked in 6 minutes (6 Minute walk distance) | 6 weeks | 
| Dyspnea Borg scale | t uses a scale from 0 to 10, where 0 represents no dyspnea and 10 represents maximal dyspnea. Scores are obtained at the end of the 6MWD test and reflect the maximum degree of dyspnea at any time during the walk. | 6 weeks |