Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06119737 |
| Other study ID # |
Batool_H |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 2, 2021 |
| Est. completion date |
October 2, 2023 |
Study information
| Verified date |
November 2023 |
| Source |
Ziauddin University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Obesity is characterized by an excessive accumulation of body fat that gives rise to
significant comorbidities, such as diabetes, hypertension, dyslipidemia, cardiovascular
disease, and many cancers. According to WHO, Obesity is a worldwide epidemic, with an
estimated 57.8% of adults worldwide expected to be classified as obese by 2030. Therefore,
obesity is invariably referred to as a crucial public health problem that requires urgent
attention to prevent obesity-related health outcomes. Thyroid dysfunction is often
accompanied by changes in body weight and body composition, leading to obesity.
The rising risk of obesity has created susceptibility for every individual irrespective of
age, gender and demography. Hence, the focus of researchers is now shifting to devising
preventive strategies from the treatment approaches for obesity. To guide healthcare
professionals in treating obesity, several guidelines from The Obesity Society (TOS) have
been prepared that outline multiple therapies like lifestyle modifications, increased
physical activities, dietary modifications, use of medications and in some cases, even
surgeries are recommended. However, poor receptivity of exercise among the general population
required healthcare professionals to design an exercise program that could be cost and
time-effective for the patient. Hence, the present study aims to determine the effect of
exercise and the documentation of the best possible exercise regime that could increase TSH
among the class I obese population.
Description:
The study is a randomized controlled trial. The participants were recruited via the envelop
method of simple random sampling technique into four groups: Moderate Intensity Continuous
Training (MICT), Resistance Training (RT), High-Intensity Interval Training (HIIT) and ½
HIIT.
The training was based on a warm-up session of 5 to 10 minutes followed by conditioning and a
cool-down phase of 5 to 10 minutes. The detailed description of each phase is as follows:
Warmup Warm-up exercises, including High Knee and Jumping Jack Exercises, were performed 5 to
10 minutes using the Lindstrom protocol to increase core body temperature and improve blood.
Conditioning Conditioning includes exercises that were performed by the participants under
the supervision of a Qualified senior Physical Therapist for varied duration of time
depending on the protocol of training.
Moderate Intensity Continuous Training Moderate-intensity endurance exercises were performed
by the participants under the supervision of a Qualified senior Physical Therapist by using
either a treadmill or cycle ergometer. Exercise frequency was 3 days per week for 16 weeks,
each session lasting for 30 minutes. The intensity was calculated using the Karovonean
method10, in which a targeted heart rate of 60-85% was maintained for the purpose of
conditioning.
THR= (MHR-RHR x Training %) + RHR
Resistance Exercise Conditioning using resistance exercises involves training of 11 major
muscle groups of the body that include i) biceps, ii) triceps, iii) deltoid, iv) trapezius,
v) latisimus dorsi, vi) pectoralis major vii) abdominals, viii) back extensors, ix)
hamstrings, x) quadriceps, and xi) calf (WLC). The protocol included strengthening exercise
with an intensity calculated by 1 Repetition maximum method technique11. Exercises were
performed three days/ week (every alternate day), and the time required for single-day
training is the time needed to complete 3 sets of 10 repetitions of each major muscle group.
High-Intensity Interval Training The HIIT protocol consisted of 10 s of the sprint, working
at 85%- 90% of HRmax and 10 s of the recovery phase, during which participants cycled as
slowly as possible for a total duration of 20 minutes. Participants were instructed when to
start and stop in each phase. The duration of the exercise session was calculated for each
participant individually.
1/2- High-Intensity Interval Training Participants in the 1/2-HIIT group followed the same
protocol as the HIIT group, but only for the duration of 10 minutes working at 85%- 90% of
HRmax of 12 s of sprint and 8 s of recovery phase.
Cool Down The cool-down session lasted for 5-10 minutes. During the period, full-body
stretches were performed with low-intensity, long-hold stretching.
Exercise Termination Criteria
The exercise session was prematurely terminated on the occurrence of one of the following:
- Modified Borg dyspnea scale (RPP) at level 8 or above.
- Decrease in oxygen saturation<90%.
- Any complaints of chest pain, leg cramps, palpitation or tiredness by the patient.
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