SmokingNCT06674174
Effect of Lower Limb Resistance Versus Endurance Training in Smokers
A study testing lower limb strength training and endurance training in people with Smoking, run by Riphah International University at 1 site in Pakistan.
Trial summary
Patients was selected based on inclusion and exclusion criteria. Experimental group was treated with Resistance training while control group received endurance training. Data was collected by spirometry and International Physical activity questionnaire readings was recorded in every session for baseline, 3rd week and… Read more about this study
- Who is it for?
- Ages 25 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- lower limb strength training and endurance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jul 2023to 18 Jul 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 25 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Young cigarette smokers (10 cigarette/day for at least 10 years)
- Male
- Age 25-45 years
- Sedentary lifestyle
- Body mass: less than 80kg
- BMI:22-30
Who cannot join
- Heart or pulmonary disease
- MSK disorder
- incapable of realizing the protocol of exercises,
- Recent surgery
- Recent Trauma.
- Any infective respiratory illness.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Lower Limb Resistance Versus Endurance Training on Pulmonary Function in Smokers With Shortness of Breath
Patients was selected based on inclusion and exclusion criteria. Experimental group was treated with Resistance training while control group received endurance training. Data was collected by spirometry and International Physical activity questionnaire readings was recorded in every session for baseline, 3rd week and 6thweeks.
Read the detailed description
Experimental group will receive lower limb strength training and control group will receive endurance training. Both groups will receive treatment for three days a week and each session will be given according to FITT formula. Measurement will be recorder pre-treatment and post treatment of both groups at baseline, third , and 6 th week.
- Conditions
- Smoking
- Being tested
- lower limb strength training, endurance training
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lower limb strength trainingOther
Experimental group will receive lower limb strength training treatment for three days a week and each session will last for an hour for 3 consecutivemonths. Measurement will be recorder pre-treatment and post treatment of both groupsat baseline,3rd, and 6th week.
endurance trainingOther
Control group will receive endurance training, treatment for three days a week and each session will last for an hour for 3 consecutivemonths. Measurement will be recorder pre-treatment and post treatment of both groupsat baseline,3rd, and 6th week.
| Study group | Role | What they receive |
|---|---|---|
| lower limb strength training | Experimental | Experimental group will receive lower limb strength training Receives: Other: lower limb strength training |
| endurance training | Other | control group will receive endurance training. Receives: Other: endurance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spirometry
Spirometry is one of the Pulmonary Function Test; they are useful investigations in the management of patients with respiratory disease or respiratory weakness secondary to neurological impairment. They aid diagnosis, help monitor response to treatment and can guide decisions regarding further treatment and intervention. Spirometry can measure all the lung volumes except residual volume.
Measured: 6 weeks
International Physical Activity Questionnaire
The International Physical Activity Questionnaire is a 27-item self-reported measure of physical activity for use with individual adult patients aged 15 to 69 years old. The International Physical Activity Questionnaire can be used clinically and in population research that compares physical activity levels between populations internationally.To calculate MET minutes a week multiply the MET value given (remember walking = 3.3, moderate activity = 4, vigorous activity = 8) by the minutes the activity was carried out and again by the number of days that that activity was undertaken. For example if someone reports walking for 30 minutes 5 days a week then the total MET minutes for that activity are 3.3 X 30 X 5=495 Met minutes a week.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start1 Jul 2023
- Primary completion15 Jul 2024
- Study completion18 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Razzaq, MsCPPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06674174
- Sponsor's protocol ID
- Masroor Alam
- Status last verified
- Nov 2024
- First submitted
- 13 Aug 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Lower Limb Resistance Versus Endurance Training on Pulmonary Function in Smokers With Shortness of Breath
- ClinicalTrials.gov ID
- NCT06674174
- Acronym / sponsor ID
- Masroor Alam
- Conditions
- Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 18 Jul 2024 (actual)
- First posted
- 5 Nov 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.
Patients was selected based on inclusion and exclusion criteria. Experimental group was treated with Resistance training while control group received endurance training. Data was collected by spirometry and International Physical activity questionnaire readings was recorded in every session for baseline, 3rd week and 6thweeks.
Detailed description
Experimental group will receive lower limb strength training and control group will receive endurance training. Both groups will receive treatment for three days a week and each session will be given according to FITT formula. Measurement will be recorder pre-treatment and post treatment of both groups at baseline, third , and 6 th week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lower limb strength training | Experimental | Other: lower limb strength trainingExperimental group will receive lower limb strength training |
| endurance training | Other | Other: endurance trainingcontrol group will receive endurance training. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Young cigarette smokers (10 cigarette/day for at least 10 years)
- Male
- Age 25-45 years
- Sedentary lifestyle
- Body mass: less than 80kg
Key exclusion criteria (6 listed)
- Heart or pulmonary disease
- MSK disorder
- incapable of realizing the protocol of exercises,
- Recent surgery
- Recent Trauma.
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 |
|---|---|---|
| lower limb strength trainingExperimental group will receive lower limb strength training treatment for three days a week and each session will last for an hour for 3 consecutivemonths. Measurement will be recorder pre-treatment and post treatment of both groupsat baseline,3rd, and 6th week. | Other | lower limb strength training |
| endurance trainingControl group will receive endurance training, treatment for three days a week and each session will last for an hour for 3 consecutivemonths. Measurement will be recorder pre-treatment and post treatment of both groupsat baseline,3rd, and 6th week. | Other | endurance training |
Primary outcome
Spirometry
Time frame: 6 weeks
Spirometry is one of the Pulmonary Function Test; they are useful investigations in the management of patients with respiratory disease or respiratory weakness secondary to neurological impairment. They aid diagnosis, help monitor response to treatment and can guide decisions regarding further treatment and intervention. Spirometry can measure all the lung volumes except residual volume.
International Physical Activity Questionnaire
Time frame: 6 weeks
The International Physical Activity Questionnaire is a 27-item self-reported measure of physical activity for use with individual adult patients aged 15 to 69 years old. The International Physical Activity Questionnaire can be used clinically and in population research that compares physical activity levels between populations internationally.To calculate MET minutes a week multiply the MET value given (remember walking = 3.3, moderate activity = 4, vigorous activity = 8) by the minutes the activity was carried out and again by the number of days that that activity was undertaken. For example if someone reports walking for 30 minutes 5 days a week then the total MET minutes for that activity are 3.3 X 30 X 5=495 Met minutes a week.
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 5 Nov 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.
Maria Razzaq, MsCPPT 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 lower limb strength training and endurance training in people with Smoking, 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 6 inclusion and 6 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 5 Nov 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. 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?
Spirometry (time frame: 6 weeks). The study lists 2 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 5 Nov 2024.