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Clinical Trials/NCT04319289
NCT04319289CompletedNot Applicable

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

Cairo University1 site in 1 country45 target enrollmentStarted: January 12, 2020Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
45
Locations
1
Primary Endpoint
Description of Functional capacity efficiency

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
30 Years to 40 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

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/m
  • 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.

Arms & Interventions

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.

Intervention: aerobic interval training and Vitamin D supplementation, (Other)

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

Intervention: Vitamin D supplementation only (Drug)

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.

Intervention: aerobic interval training only (Other)

Outcomes

Primary Outcomes

Description of Functional capacity efficiency

Time Frame: It is performed before and after the study(12 weeks interval) for all groups

Cooper 12-Minute Walk Test (12MWT)

Intensity of non specific muscle pain (myalgia)

Time Frame: It is performed before and after the study(12 weeks interval) for all groups

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

Time Frame: It is performed before and after the study(12 weeks interval) for all groups

The Short form health survey (SF-12)is often used to compare health status between groups of patients, to indentify predictors of health status

Concentration of Plasma Serum vitamin D level (25OHD)

Time Frame: It is performed before and after the study(12 weeks interval) for all groups

It is performed by Laboratory BioPlex® 2200 System

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Heba Ahmed Ali Abdeen

Assistant professor, Faculty of Physical Therapy

Cairo University

Study Sites (1)

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