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

Primary Purpose

Vitamin D Deficiency

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
aerobic interval training and Vitamin D supplementation,
Vitamin D supplementation only
aerobic interval training only
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitamin D Deficiency

Eligibility Criteria

30 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of Physical Therapy

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group (A)

Group (B)

Group (c)

Arm Description

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.

Included 15 patients who are receiving vitamin D supplementation only . One capsule containing (cholecalciferol 400 IU) was taken every day for 12 weeks

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.

Outcomes

Primary Outcome Measures

Concentration of Plasma Serum vitamin D level (25OHD)
It is performed by Laboratory BioPlex® 2200 System
Description of Functional capacity efficiency
Cooper 12-Minute Walk Test (12MWT)
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
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

Secondary Outcome Measures

Full Information

First Posted
March 22, 2020
Last Updated
May 29, 2020
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04319289
Brief Title
Effect of Aerobic Interval Training With Vitamin D Supplement on Functional Capacity and Perceived Myalgia
Official Title
Effect of Aerobic Interval Training Combined With Vitamin D Supplement on Functional Capacity and Perceived Myalgia in Middle Aged Obese Women
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
January 12, 2020 (Actual)
Primary Completion Date
May 15, 2020 (Actual)
Study Completion Date
May 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group (A)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group (B)
Arm Type
Experimental
Arm Description
Included 15 patients who are receiving vitamin D supplementation only . One capsule containing (cholecalciferol 400 IU) was taken every day for 12 weeks
Arm Title
Group (c)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
aerobic interval training and Vitamin D supplementation,
Intervention Description
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
Drug
Intervention Name(s)
Vitamin D supplementation only
Intervention Description
One capsule containing (cholecalciferol 400 IU) was taken every day .
Intervention Type
Other
Intervention Name(s)
aerobic interval training only
Intervention Description
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
Primary Outcome Measure Information:
Title
Concentration of Plasma Serum vitamin D level (25OHD)
Description
It is performed by Laboratory BioPlex® 2200 System
Time Frame
It is performed before and after the study(12 weeks interval) for all groups
Title
Description of Functional capacity efficiency
Description
Cooper 12-Minute Walk Test (12MWT)
Time Frame
It is performed before and after the study(12 weeks interval) for all groups
Title
Intensity of non specific muscle pain (myalgia)
Description
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
Time Frame
It is performed before and after the study(12 weeks interval) for all groups
Title
Description of the improvement in Quality of life
Description
The Short form health survey (SF-12)is often used to compare health status between groups of patients, to indentify predictors of health status
Time Frame
It is performed before and after the study(12 weeks interval) for all groups

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Faculty of Physical Therapy
City
Cairo
ZIP/Postal Code
12316
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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

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