Clinical trial NCT06077552: Effect of Pyramidal Training on Selected Risk Factors of Atherosclerosis
Official title: Effect of Pyramidal Training on Selected Risk Factors of Atherosclerosis in Women With Central Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Atherosclerosis
Keywords: obesity
risk factor
lipid profile
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-10-11
Enrollment: 60
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will be conducted on fifty women with central obesity. Their ages will be from 30-40 years old. They will be selected from Al Hayat specialized Hospital in Cairo, Egypt and The participants will be randomly assigned into two equal groups:

Group (A): study group, 25 participants will receive pyramidal training by treadmill for 40 minutes per session three sessions per week for eight weeks in addition to the diet health advices.

Group (B): Control group, 25 participants will receive diet health advices. The subjects will be selected from El Haya specialized Hospital, Cairo.

Detailed description: The study will be conducted on fifty women with central obesity. Their ages will be from 30-40 years old. They will be selected from Al Hayat specialized Hospital in Cairo, Egypt and The participants will be randomly assigned into two equal groups:

Group (A): study group, 25 participants will receive pyramidal training by treadmill for 40 minutes per session three sessions per week for eight weeks in addition to the diet health advices.

Group (B): Control group, 25 participants will receive diet health advices. The subjects will be selected from El Haya specialized Hospital, Cairo. Before starting the procedure the participants target heart rate (THR) will be calculated from Karvonen formula as follow: target heart rate (THR) = maximum heart rate (HRmax) - resting heart rate × intensity + resting heart rate(RHR)(Yabe et al.,2021).

The formula 208-0.7•age yield more precise estimates of HRmax over a wide age range (Nes et al., 2013).

After calculating THR, the study group participants will be on a pyramidal training program of incremental and decremental levels as follow:

The course of the program will be 2 sets of pyramidal training with 10 minutes for rest between them. each set will be 5 levels of incremental and 5 levels of decremental aerobic exercise and each level 2 minutes on a treadmill. All these levels will be ranked according to a percentage from the THR; the ranking will be as follow:

1. Level one: will be set as a 20% walking of Karvonen formula.
2. Level two: will be set as a 30% running of Karvonen formula.
3. Level three: will be set as a 50%running of Karvonen formula.
4. Level four: will be set as a 70% running of Karvonen formula.
5. Level five: will be set as a 80% running of Karvonen formula The whole program will be 40 minutes with warm up and cool down 5 minutes of stretch exercise for each. Participants will be asked to get on the treadmill and start the program, the therapist is monitoring the heart rate by using a pulse oximeter, and when the participants reach targeted percent of Karvonen formula, the therapist set the treadmill by increasing the speed to enter or start the up next level till reaching the highest level then start the decremental phase of the pyramidal training. The therapist shifts between the level by time or targeted percent of Karvonen formula which comes first.

Eligibility criteria: Inclusion Criteria:

* 1) Fifty women with central obesity. 2) Waist circumference \> 88 cm. 3) Their age will be ranged from 30-40years old. 4) Body mass index (BMI) from 30 to 34.9 kg/m2. 5) High normal or abnormal lipid profile (total cholesterol \> 200 mg/dl, HDL\< 35 mg/dl, or triglycerides \>150 mg/dl) and atherogenic index of plasma (AIP) ranges 0.11-0.21 6) HOMA-IR \> 2.9 7) They are clinically and medically stable. 8) All participants are sedentary activity level according to physical activity index.

Exclusion Criteria:

* 1) Participants with musculoskeletal problems (e.g., Sever osteoarthritis or difficulties in ambulation).

  2) Participants with uncontrolled pulmonary disease. (e.g., Exaggerated chronic obstructive pulmonary disease, acute asthma).

  3) Any participants who missed more than two weeks of the program or want to terminate the program.

  4) Participants with unstable angina, uncontrolled cardiac arrhythmia, decompensated heart failure.

  5) The participants have hearing impairment or mental disorders. 6) Implanted pacemaker. 7) Diabetes and hypertension.

Primary outcomes:
measure: atherogenic index of plasma
timeFrame: 8 weeks
Secondary outcomes:
measure: Waist circumference
timeFrame: 8 weeks
measure: Body mass index
timeFrame: 8 weeks
measure: lipid profile
timeFrame: 8 weeks
measure: insulin resistance
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Physical Therapy
state: Dokki
Study officials:
affiliation: Cairo University
name: Marwa elsayed, PhD
role: PRINCIPAL_INVESTIGATOR
References: