Effect of Aerobic Interval Training With Vitamin D Supplement on Functional Capacity and Perceived Myalgia

Vitamin D Deficiency Clinical Trial

Official title:

Effect of Aerobic Interval Training Combined With Vitamin D Supplement on Functional Capacity and Perceived Myalgia in Middle Aged Obese Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04319289
• Other study ID #: 2020HAAE
• Status: Completed
• Phase: N/A
• Start date: January 12, 2020
• Est. completion date: May 20, 2020

Study information

• Verified date: May 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aimed to investigate whether there will be an effect of adding a program of aerobic interval training in managing patients suffering from myalgia associated with vitamin D deficiency.

Description:

Forty five women complaining from myalgia with vitamin D deficiency participating in this study. Their ages are ranged from 30 to 40 years.

They are assigned randomly into three groups:

• Group (A): included 15 patients who are participating in an aerobic interval training exercise program with vitamin D supplementation (cholecalciferol 400 IU/day).

• Group (B): included 15 patients who are receiving vitamin D supplementation only (cholecalciferol 400 IU/day).

• Group (C): included 15 patients who are participating in an interval training exercise program only.

The intervention will last for 12 weeks

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: May 20, 2020
• Est. primary completion date: May 15, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 40 Years

Eligibility

Inclusion Criteria:

• Forty five sedentry women with non specific myalgia pain.

• The patients' ages ranged from 30 -40 years.

• All patients have non specific muscle pain for more than 2 months.

• They have vitamin D deficiency.

• All patients have BMI from 25 to 34.9 kg/m2.

• All patients were clinically and medically stable when attending the study.

Exclusion Criteria:

• Unstable cardiovascular and chest problems.

• Patients with diseases which affect vitamin D level as a history of rheumatic or metabolic bone diseases and diabetes.

• Patients taking drugs which affect vitamin D level as steroids and anticonvulsants drugs .

• Musculoskeletal disorders which may affect their physical ability to do the exercises.

Related Conditions & MeSH terms

• Myalgia
• Vitamin D Deficiency

Intervention

Other:
• aerobic interval training and Vitamin D supplementation,
The participants in both groups A will be instructed to perform aerobic interval exercises at 70% maxHR for 5 minutes and then decrease activity to 50% for 5 minutes and repeat for the length of the activity (the training will be done by using bicycle ergometer(Biodex LBC, Biodex Inc., New York).• Before starting training ; Maximum heart rate calculated from the following equation: maxHR= 220-age . Duration: the first five to ten minutes of each session were dedicated to warming up exercise on the bicycle in the form of slow progression exercise (to decrease the risk of hypotension, musculoskeletal injury and cardiovascular complications), followed by the active phase of exercise for 40 min., and finally cooling down phase for ten minutes. with intensity and speed decreased gradually until reaching the resting HR Frequency: 3 days/week., for 12 weeks Also all participants in this group are taking gne capsule containing (cholecalciferol 400 IU) every day .

Drug:
• Vitamin D supplementation only
One capsule containing (cholecalciferol 400 IU) was taken every day .

Other:
• aerobic interval training only
The participants in group C will be instructed to perform aerobic interval exercises at 70% maxHR for 5 minutes and then decrease activity to 50% for 5 minutes and repeat for the length of the activity (the training will be done by using bicycle ergometer(Biodex LBC, Biodex Inc., New York).• Before starting training ; Maximum heart rate calculated from the following equation: maxHR= 220-age (Gellish ,2007). Duration: the first five to ten minutes of each session were dedicated to warming up exercise on the bicycle in the form of slow progression exercise (to decrease the risk of hypotension, musculoskeletal injury and cardiovascular complications), followed by the active phase of exercise for 40 min., and finally cooling down phase for ten minutes. with intensity and speed decreased gradually until reaching the resting heart rate (Broderick et al.,2014). Frequency: 3 days/week. The whole training lasting for 12 weeks

Locations

Country	Name	City	State
Egypt	Faculty of Physical Therapy	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of Plasma Serum vitamin D level (25OHD)	It is performed by Laboratory BioPlex® 2200 System	It is performed before and after the study(12 weeks interval) for all groups
Primary	Description of Functional capacity efficiency	Cooper 12-Minute Walk Test (12MWT)	It is performed before and after the study(12 weeks interval) for all groups
Primary	Intensity of non specific muscle pain (myalgia)	A 10-cm Visual Analogue Scale (VAS) was used to evaluate the patients' pain , with 0 representing no pain and 10 representing the worst pain imaginable	It is performed before and after the study(12 weeks interval) for all groups
Primary	Description of the improvement in Quality of life	The Short form health survey (SF-12)is often used to compare health status between groups of patients, to indentify predictors of health status	It is performed before and after the study(12 weeks interval) for all groups