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Completed

NCT Number: NCT04319289

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

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.

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Key information

Conditions

Vitamin D Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

30 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Physical Therapy

Cairo, 12316, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 .

Vitamin D supplementation only

Drug

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

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

Primary outcomes

  1. 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

  2. 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)

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 24, 2020
Registry last updated
Jun 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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