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Completed

NCT Number: NCT04676074

Effect of Upper Limb Ergometer on the AIP in Post Menopausal Obese Women.

Participants had randomly divided into two equal groups. Group (A) which is the control group receive normal routine medication. Group (B) will receive normal routine medication with the treatment program of moderate intensity upper limb ergometer for 15 minute with frequency three times per week for four weeks.

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Key information

Age range

45 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Outpatient clinic faculty of physical therapy at Cairo University

Giza, 12613, Egypt

About this study

Control group (A):

  • Each participant will sign a consent form after receiving a detailed explanation about the procedure.
  • A blood sample will been taken by a nurse in a heparinized tube and delivered to lab within six hours.
  • BMI will been measured body weight(Kg) and height (m2)

a. BMI= body weight (Kg)/ height (m2).

  • Waist circumference will be measured.
  • After one month blood analysis evaluation will be done to record the response to the routine medication.

Training Procedure for group (B):

  • Each participant will sign a consent form after receiving a detailed explanation about the procedure.
  • A blood sample will been taken by a nurse in a heparinized tube and delivered to lab within six hours.
  • BMI will been measured body weight(Kg) and height (m2)

a. BMI= body weight (Kg)/ height (m2).

  • Waist circumference will be measured.
  • The maximum heart rate will be determined from Tanaka formula (208- 0.7 *age of the participant)
  • Then the exercise load will be determined according heart rate reserve of the participants ( maximum heart rate - resting heart rate).
  • Start with sitting resting without any effort for 5 min then Start at a low speed and intensity for 5 minutes to warm up the body.
  • Increase the speed and intensity for 10-30 seconds before dropping it back for 2-5 minutes and Repeat according to the intensity.
  • Finally, a five minutes of cooling down with no resistance had performed.
  • After one month blood analysis evaluation will be done to record the response to the routine medication.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • female aged 45-60 years old.
  • class 1 and 2 obesity.
  • post menopausal.
  • diagnosed as controlled diabetic.
  • diagnosed as controlled hypertensive.

Exclusion criteria

  • uncontrolled diabetic.
  • uncontrolled hypertensive.
  • class 3 and morbid obesity.
  • mentally unstable person.
  • Any shoulder, hand and elbow orthopedic or neural disorders.

Treatment and study plan

Electronic Upper limb( body) ergometer

Device

Electronic pedal for the upper limb using for training the upper body. Intensity, speed and resistance can be adjusted.

Primary outcomes

  1. Effect of the upper body ergometer on arthrogenic index ( triglyceride/ high density lipoprotein)

    Time frame: after one month of the trial application

    Effect of the upper body ergometer on arthrogenic index ( triglyceride/ high density lipoprotein)

Secondary outcomes

  1. Effect of the upper body ergometer on total body weight kg.

    Time frame: after one month of the trial application

    Effect of the upper body ergometer on total body weight kg.

  2. Effect of the upper body ergometer on estimated maximum heart rate(beat/min).

    Time frame: after one month of the trial application

    Effect of the upper body ergometer on estimated maximum heart rate(beat/min).

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Effect of Upper Limb Ergometer on the Arthrogenic Index of Plasma in Post Menopausal Obese Women.

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 19, 2020
Registry last updated
Jun 8, 2021

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.