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

NCT ID: NCT04319289

Last Updated: 2020-06-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-12
• Study Completion Date: 2020-05-20

Brief 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.

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

Conditions

Vitamin D Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

aerobic interval training and Vitamin D supplementation,

Intervention Type: OTHER

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 .

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

Group Type: EXPERIMENTAL

Vitamin D supplementation only

Intervention Type: DRUG

One capsule containing (cholecalciferol 400 IU) was taken every day .

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.

Group Type: EXPERIMENTAL

aerobic interval training only

Intervention Type: OTHER

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

Interventions

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 .

Intervention Type: OTHER

Vitamin D supplementation only

One capsule containing (cholecalciferol 400 IU) was taken every day .

Intervention Type: DRUG

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Heba Ahmed Ali Abdeen

Assistant professor, Faculty of Physical Therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Physical Therapy

Cairo, , Egypt

Countries

Egypt

Other Identifiers

2020HAAE

Identifier Type: -

Identifier Source: org_study_id