ObesityNCT06119737
Effects of Exercise on Thyroid Stimulating Hormone Among Class-I Obese Patients With Diabetes Mellitus and Lipid Disorders
A study testing Exercise in people with Obesity, run by Ziauddin University at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Obesity
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 sitePakistan
- Study dates
- 2 May 2021to 2 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Class I obese population BMI ≥25.0 -30.0
- Young adults aged 20-40 years
- Diagnosed patients with DM and dyslipidemia.
Who cannot join
- -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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Obesity
- Being tested
- Exercise
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Effects of exercises on TSH levels
| Study group | Role | What they receive |
|---|---|---|
| Moderate Intensity Continuous Training | Experimental | Not described Receives: Other: Exercise |
| Resistance Training | Active comparator | Not described Receives: Other: Exercise |
| High-Intensity Interval Training | Active comparator | Not described Receives: Other: Exercise |
| 1/2- High-Intensity Interval Training | Active comparator | Not described Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start2 May 2021
- Primary completion15 Jul 2023
- Study completion2 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ziauddin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Batool Hassan, Ziauddin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06119737
- Sponsor's protocol ID
- Batool_H
- Status last verified
- Nov 2023
- First submitted
- 1 Nov 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exercise on Thyroid Stimulating Hormone Among Class-I Obese Patients With Diabetes Mellitus and Lipid Disorders
- ClinicalTrials.gov ID
- NCT06119737
- Acronym / sponsor ID
- Batool_H
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Ziauddin UniversityUniversity, hospital or other
- Study start
- 2 May 2021 (actual)
- Primary completion
- 15 Jul 2023 (actual)
- Study completion
- 2 Oct 2023 (actual)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Class I obese population BMI ≥25.0 -30.0
- Young adults aged 20-40 years
- Diagnosed patients with DM and dyslipidemia.
Key exclusion criteria (1 listed)
- -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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseEffects of exercises on TSH levels | Other | 1/2- High-Intensity Interval Training, High-Intensity Interval Training, Moderate Intensity Continuous Training, Resistance Training |
Primary outcome
Thyroid Stimulating Hormone
Time frame: 16 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Obesity, run by Ziauddin University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thyroid Stimulating Hormone (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.