NCT06119737

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started May 2021

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 2, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 1, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 7, 2023

Completed
Last Updated

November 7, 2023

Status Verified

November 1, 2023

Enrollment Period

2.2 years

First QC Date

November 1, 2023

Last Update Submit

November 1, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Thyroid Stimulating Hormone

    The levels of TSH were measured using blood sample (Biodata Diagnostic brand RIA kit)12. The samples were taken twice once before the start of the training protocol and second after the completion of 16 weeks of training. The difference in the values between the groups was used to evaluate the impact of exercises thyroid hormone levels in the body.

    16 weeks

Study Arms (4)

Moderate Intensity Continuous Training

EXPERIMENTAL
Other: Exercise

Resistance Training

ACTIVE COMPARATOR
Other: Exercise

High-Intensity Interval Training

ACTIVE COMPARATOR
Other: Exercise

1/2- High-Intensity Interval Training

ACTIVE COMPARATOR
Other: Exercise

Interventions

Effects of exercises on TSH levels

1/2- High-Intensity Interval TrainingHigh-Intensity Interval TrainingModerate Intensity Continuous TrainingResistance Training

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Class I obese population BMI ≥25.0 -30.0
  • Young adults aged 20-40 years
  • Diagnosed patients with DM and dyslipidemia.

You may not qualify if:

  • Patients diagnosed with pre-existing heart conditions, major illness (acute or chronic), beta-blockers, pregnant or lactating women, and smokers, including any that would limit the ability to perform the necessary exercises, will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ziauddin University

Karachi, Sindh, Pakistan

Location

MeSH Terms

Conditions

Obesity

Interventions

Exercise

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 1, 2023

First Posted

November 7, 2023

Study Start

May 2, 2021

Primary Completion

July 15, 2023

Study Completion

October 2, 2023

Last Updated

November 7, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations