Clinical trial NCT04676074: Effect of Upper Limb Ergometer on the AIP in Post Menopausal Obese Women.
Official title: Effect of Upper Limb Ergometer on the Arthrogenic Index of Plasma in Post Menopausal Obese Women.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Menopausal Obese Women
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-12-19
Enrollment: 40
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Control group (A):

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

   a. BMI= body weight (Kg)/ height (m2).
4. Waist circumference will be measured.
5. After one month blood analysis evaluation will be done to record the response to the routine medication.

Training Procedure for group (B):

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

   a. BMI= body weight (Kg)/ height (m2).
4. Waist circumference will be measured.
5. 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).
6. 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.
7. Increase the speed and intensity for 10-30 seconds before dropping it back for 2-5 minutes and Repeat according to the intensity.
8. Finally, a five minutes of cooling down with no resistance had performed.
9. After one month blood analysis evaluation will be done to record the response to the routine medication.

Eligibility criteria: 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.

Primary outcomes:
measure: Effect of the upper body ergometer on arthrogenic index ( triglyceride/ high density lipoprotein)
timeFrame: after one month of the trial application
Secondary outcomes:
measure: Effect of the upper body ergometer on total body weight kg.
timeFrame: after one month of the trial application
measure: Effect of the upper body ergometer on estimated maximum heart rate(beat/min).
timeFrame: after one month of the trial application
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Outpatient clinic faculty of physical therapy at Cairo University
Study officials:
affiliation: Faculty of physical therapy at Cairo University
name: Rana H El Banna, PHD
role: PRINCIPAL_INVESTIGATOR
References: