Comparison of Aerobic Exercise and Resistance TrainingNCT06377826
Comparison of Aerobic and Resistance Training on Exercise Capacity, Depression and Quality of Life in Hypothyroidism.
A study testing aerobic exercises, resistance training and medication in people with Comparison of Aerobic Exercise and Resistance Training, run by Riphah International University at 1 site in Pakistan.
Trial summary
the study will show the effects of aerobic and resistance training on exercise capacity, depression and quality of life in patients with hypothyroidism. The evaluation of TSH level before and after the exercise sessions will provide valuable data. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Comparison of Aerobic Exercise and Resistance Training
- What is being tested?
- aerobic exercises, resistance training and medication
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2024to 1 Jun 2024
- 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both males and females Age between 40 to 60 years Diagnosed cases of hypothyroidism Duration: 2 years being diagnosed Patients who easily perform exercises
Who cannot join
- Patients with serious comorbidities like cancer Uncontrolled hypertension Vitally unstable patients Red flags for physiotherapy
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Abbottabad medical complex
Abbottābād, Khyber Pakhtunkhwa, 21300
saira jahan, MS, 031591289095, saira.jahan@riphah.edu.pk
Usama Iqbal
About this study
Official title: To Compare the Effects of Aerobic and Resistance Training on Exercise Capacity, Depression and Quality of Life in Hypothyroidism.
the study will show the effects of aerobic and resistance training on exercise capacity, depression and quality of life in patients with hypothyroidism. The evaluation of TSH level before and after the exercise sessions will provide valuable data.
Read the detailed description
The study aims to investigate the effects of aerobic exercise and resistance training by comparing the two types of exercises, the finding of this study gain insights into the most effective approach for patients with hypothyroidism particularly in relation to exercise capacity, depression and quality of life. The study design is Randomized Controlled Trial. Sample size is calculated using G power program. the study duration is 6 months after the approval of research board. Non probability Purposive sampling is used for this study. Data will be analyzed by using SPSS version 20.
- Being tested
- aerobic exercises, resistance training, medication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic exercisesOther
group A will receive aerobic training like walking and cycling for 03 times per week approximately each exercise 5 to 10 minutes for 8 weeks.
resistance trainingOther
this group will receive resistance training like gluteal bridge, calf raise, squats, seated shoulder press for 03 times per week approximately each exercise 5 to 10 minutes for 8 weeks.
medicationDrug
This group will be just on medication and no exercise will be given to this group
| Study group | Role | What they receive |
|---|---|---|
| aerobic exercises | Active comparator | Aerobic exercises i-e treadmill walking, bicycle ergometer, Treadmill Receives: Other: aerobic exercises |
| resistance training | Experimental | resistance exercise training gluteal bridge, calf raises, squats, seated shoulder press, Receives: Other: resistance training |
| medication | Placebo comparator | only on drugs no exercise is given Receives: Drug: medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 Minute Walk Test
The six minute walk test 96 The six minute walking test (6MWT) was developed by the American Thoracic Society and it was officially introduced in 2002, coming along with a comprehensive guideline. The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. The 6-minute walk test (6MWT) is commonly used to measure the functional exercise capacity in chronic patients with cardiovascular disease.
Measured: 8 weeks
The Beck Depression Inventory Scale
The Beck Depression Inventory (BDI, BDI-1A, BDI-II), created by Aaron T. Beck, is a 21-question multiple-choice self-report inventory, one of the most widely used psychometric tests for measuring the severity of depression. Its development marked a shift among mental health professionals, who had until then, viewed depression from a psychodynamic perspective, instead of it being rooted in the patient's own thoughts. Each question had a set of at least four possible responses, ranging in intensity. Higher total scores indicate more severe depressive symptom.
Measured: 8 weeks
SF- 36 SF-36
SF- 36-Item Short Form Survey (SF-36) is an outcome measure instrument that is often used, well-researched, self-reported measure of health. It stems from a study called the Medical Outcomes Study for the objective measure of the quality of life.
It comprises 36 questions that cover eight domains of health. The SF-36 is often used as a measure of a person or population's quality of life (QOL).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start1 Apr 2024
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Comparison of Aerobic Exercise and Resistance TrainingStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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, Investigator
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- saira jahan, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06377826
- Sponsor's protocol ID
- RCRAHS-ISB/REC/MS-PT/01813
- Status last verified
- Apr 2024
- First submitted
- 18 Apr 2024
- Last updated
- 22 Apr 2024
- 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 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Compare the Effects of Aerobic and Resistance Training on Exercise Capacity, Depression and Quality of Life in Hypothyroidism.
- ClinicalTrials.gov ID
- NCT06377826
- Acronym / sponsor ID
- RCRAHS-ISB/REC/MS-PT/01813
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 22 Apr 2024 (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.
the study will show the effects of aerobic and resistance training on exercise capacity, depression and quality of life in patients with hypothyroidism. The evaluation of TSH level before and after the exercise sessions will provide valuable data.
Detailed description
The study aims to investigate the effects of aerobic exercise and resistance training by comparing the two types of exercises, the finding of this study gain insights into the most effective approach for patients with hypothyroidism particularly in relation to exercise capacity, depression and quality of life. The study design is Randomized Controlled Trial. Sample size is calculated using G power program. the study duration is 6 months after the approval of research board. Non probability Purposive sampling is used for this study. Data will be analyzed by using SPSS version 20.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| aerobic exercises | Active comparator | Other: aerobic exercisesAerobic exercises i-e treadmill walking, bicycle ergometer, Treadmill |
| resistance training | Experimental | Other: resistance trainingresistance exercise training gluteal bridge, calf raises, squats, seated shoulder press, |
| medication | Placebo comparator | Drug: medicationonly on drugs no exercise is given |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Both males and females Age between 40 to 60 years Diagnosed cases of hypothyroidism Duration: 2 years being diagnosed Patients who easily perform exercises
Key exclusion criteria (1 listed)
- Patients with serious comorbidities like cancer Uncontrolled hypertension Vitally unstable patients Red flags for physiotherapy
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 |
|---|---|---|
| aerobic exercisesgroup A will receive aerobic training like walking and cycling for 03 times per week approximately each exercise 5 to 10 minutes for 8 weeks. | Other | aerobic exercises |
| resistance trainingthis group will receive resistance training like gluteal bridge, calf raise, squats, seated shoulder press for 03 times per week approximately each exercise 5 to 10 minutes for 8 weeks. | Other | resistance training |
| medicationThis group will be just on medication and no exercise will be given to this group | Drug | medication |
Primary outcome
6 Minute Walk Test
Time frame: 8 weeks
The six minute walk test 96 The six minute walking test (6MWT) was developed by the American Thoracic Society and it was officially introduced in 2002, coming along with a comprehensive guideline. The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. The 6-minute walk test (6MWT) is commonly used to measure the functional exercise capacity in chronic patients with cardiovascular disease.
The Beck Depression Inventory Scale
Time frame: 8 weeks
The Beck Depression Inventory (BDI, BDI-1A, BDI-II), created by Aaron T. Beck, is a 21-question multiple-choice self-report inventory, one of the most widely used psychometric tests for measuring the severity of depression. Its development marked a shift among mental health professionals, who had until then, viewed depression from a psychodynamic perspective, instead of it being rooted in the patient's own thoughts. Each question had a set of at least four possible responses, ranging in intensity. Higher total scores indicate more severe depressive symptom.
SF- 36 SF-36
Time frame: 8 weeks
SF- 36-Item Short Form Survey (SF-36) is an outcome measure instrument that is often used, well-researched, self-reported measure of health. It stems from a study called the Medical Outcomes Study for the objective measure of the quality of life. It comprises 36 questions that cover eight domains of health. The SF-36 is often used as a measure of a person or population's quality of life (QOL).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
- 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.
saira jahan principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aerobic exercises, resistance training and medication in people with Comparison of Aerobic Exercise and Resistance Training, run by Riphah International 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 1 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: status not confirmed, as of the sponsor's last update on 22 Apr 2024. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad, Phd (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 Minute Walk Test (time frame: 8 weeks). The study lists 3 primary outcomes in all. 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 22 Apr 2024.