Study to evaluate the efficacy of belt on abdominal endurance in healthy males and females.
- Registration Number
- CTRI/2014/05/004611
- Lead Sponsor
- Spectrum Clinical Research Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 90
1.Subjects between the ages of 25 -50 years old,
2.To have a Body Mass Index (BMI) between 24 - 31,
3.Not involved in any type of formal abdominal training program within the previous 6 months.
4.No plans to engage in formal training or new sports that would be expected to affect body weight or abdominal muscles.
5.Pinch test to measure the thickness of subcutaneous fat.
6.Waist Circumference measurements.
7. Subjects willing to continue their routine diet and not to undertake a diet plan for the entire duration of the study.
8.Subjects with muscle power grade 3 to 5.Defined as Medical Research Council. London: HMSO, 1975 (Annexure II).
1.Subjects with a cardiac pacemaker.
2.Any abdominal implants.
3.Subjects who are unable to reach the second tape in supine position during the sit-ups exercise.
4.No history of recent injury to the low back,
5.No spine surgery or instrumentations done,
6.Gravid uterus
7.Non compliance with the diet instruction (Diet Control for calorie and fluid intake).
8.Menstrual cycle complications like frequent change in abdominal shape, fluid retention and general well being.
9.Pregnant and lactating for the past 12 months.
10.Treatment for any type of cancer within the last six months.
11.Individuals who have any implanted medical devices (pacemaker, pump, catheter, etc.).
12.Current or history of a medical condition that would contraindicate treatment with the product, such as epilepsy, hernia, abdominal ulcer, diabetes, or other conditions which, in the opinion of the Investigator, would place the participant at risk.
13.A current skin disease of any type at the test site (e.g. acne, eczema, psoriasis, burns, abrasions, etc.)
14.Heavy alcohol consumption in the opinion of the investigator.
15.A fever in the last 12 hours prior to the first application of the test device.
16.History of heart disease.
17.History of stroke.
18.History of malignant disease.
19.Insulin dependent diabetes.
20.Concurrent medication likely to affect the response to the test article or confuse the results of the study (e.g. routine high dose use of any drugs that may artificially affect skin tone).
21.Individuals who are currently participating in any other clinical. Investigation, or who have participated in a study with the same indication within 1 year.
22.Participants with skin conditions such as obvious sun damage, increased pigmentation and / or telangectasia.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate Abdomen muscle strength and endurance improvementTimepoint: From baseline visit to Day 75
- Secondary Outcome Measures
Name Time Method To evaluate Abdominal and waist girth reduction, Changes in skin fold thickness, Improvement in abdominal shape and toning by vivo and pictures, Improvement in skin tightness and elasticity by expert graders and Quality of lifeTimepoint: From baseline visit to Day 75