Physical Exercise and Diet Management in Vitamin D Deficient Females

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

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.

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency
• Intervention / Treatment: Other: Home Based Physical Exercise; Dietary supplement: Vitamin D3 Supplements; Behavioral: Sun Exposure; Other: Diet Management

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Al Jouf
    • Jazan, Al Jouf, Saudi Arabia, 85846
      • College of Applied Medical Sciences, Jouf University, Kingdom of Saudi Arabia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.; Dietary supplement: Vitamin D3 Supplements; Vitamin D3 supplement (400mg) once daily.; Behavioral: 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
Experimental: 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.	Dietary supplement: Vitamin D3 Supplements; Vitamin D3 supplement (400mg) once daily.; Behavioral: 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; Other: Diet Management; Patients receive weekly diet program contains dietary sources of Vitamin D such as yolk eggs, tuna and milk.
Experimental: 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.	Dietary supplement: Vitamin D3 Supplements; Vitamin D3 supplement (400mg) once daily.; Behavioral: 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
No Intervention: Control group; This group composed of 30 participants who didn't receive any intervention

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Badr University
• Investigators: Study Chair: Wael OA Abd El-Khalek, Dr., Dept of Basic Sciences, Faculty of PT, BUC, Cairo, Egypt.; Study Chair: Doaa Saeed, Dr., Dept of PT for women's health, Faculty of PT, BUC, Cairo, Egypt.; Study Chair: Mina AG Elias, Dr., Dept of PT for Internal Medicine & Geriatrics, Faculty of PT, BUC, Cairo, Egypt.; Principal Investigator: Heba A Bahey El-Deen, Prof. Dr., Dept of PT & Health Rehabilitation, College of Applied Medical Sciences, Jouf University, KSA.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: October 28, 2023
• First Submitted That Met QC Criteria: October 28, 2023
• First Posted (Actual): November 2, 2023

Study Record Updates

• Last Update Posted (Actual): November 2, 2023
• Last Update Submitted That Met QC Criteria: October 28, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin D Deficiency; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: BUC-IACUC-231015-43

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No