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

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

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.

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency
• Intervention / Treatment: Other: aerobic interval training and Vitamin D supplementation,; Drug: Vitamin D supplementation only; Other: aerobic interval training only

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 12316
    • Faculty of Physical Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

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

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group (A); Included 15 patients who are participating in an aerobic interval training exercise program with vitamin D supplementation (cholecalciferol 400 IU/day). The aerobic interval training is conducted for one hour, three days per week on a total period of 12 weeks.	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 .
Experimental: Group (B); Included 15 patients who are receiving vitamin D supplementation only . One capsule containing (cholecalciferol 400 IU) was taken every day for 12 weeks	Drug: Vitamin D supplementation only; One capsule containing (cholecalciferol 400 IU) was taken every day .
Experimental: Group (c); Included 15 patients who are participating in an aerobic interval training exercise program only. The aerobic interval training is conducted for one hour, three days per week on a total period of 12 weeks.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2020
• Primary Completion (Actual): May 15, 2020
• Study Completion (Actual): May 20, 2020

Study Registration Dates

• First Submitted: March 22, 2020
• First Submitted That Met QC Criteria: March 22, 2020
• First Posted (Actual): March 24, 2020

Study Record Updates

• Last Update Posted (Actual): June 2, 2020
• Last Update Submitted That Met QC Criteria: May 29, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Nutrition Disorders; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Musculoskeletal Pain; Avitaminosis; Deficiency Diseases; Malnutrition; Myalgia; Vitamin D Deficiency; Physiological Effects of Drugs; Micronutrients; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Vitamins; Ergocalciferols
• Other Study ID Numbers: 2020HAAE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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