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

NCT04319289 | Completed

• 1 other identifier: 2020HAAE
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin D Deficiency

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (3)

Group (A)

EXPERIMENTAL

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,

Group (B)

EXPERIMENTAL

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

Group (c)

EXPERIMENTAL

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

Interventions

aerobic interval training and Vitamin D supplementation, 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 (A)

Vitamin D supplementation only DRUG

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

Group (B)

aerobic interval training only 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

Group (c)

Eligibility Criteria

• Age: 30 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy

Cairo, 12316, Egypt

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor, Faculty of Physical Therapy

Study Record Dates

• First Submitted: March 22, 2020
• First Posted: March 24, 2020
• Study Start: January 12, 2020
• Primary Completion: May 15, 2020
• Study Completion: May 20, 2020
• Last Updated: June 2, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)