Physical Exercise and Diet Management in Vitamin D Deficient Females

Sponsor

Badr University (Other)

Overall Status

Completed

CT.gov ID

NCT06114381

Collaborator

(none)

120

Enrollment

Location

Arms

5.9

Actual Duration (Months)

20.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Vitamin D Deficiency	Other: Home Based Physical Exercise Dietary Supplement: Vitamin D3 Supplements Other: Diet Management Behavioral: Sun Exposure	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2023

Actual Primary Completion Date :

Jun 30, 2023

Actual Study Completion Date :

Jun 30, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Vitamin D3 blood test [6 weeks]
Measuring of Vitamin D3 in Blood through lab test

Secondary Outcome Measures

Hamilton Depression Rating Scale (HAMD) [6 weeks]
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 Minutes Walk Test [6 weeks]
Measuring the distance patient walked in 6 minutes (6 Minute walk distance)
Dyspnea Borg scale [6 weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 25 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	College of Applied Medical Sciences, Jouf University, Kingdom of Saudi Arabia	Jazan	Al Jouf	Saudi Arabia	85846

Sponsors and Collaborators

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

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

ClinicalTrials.gov Identifier:

NCT06114381

Other Study ID Numbers: