Immune System DiseasesProAFIMNCT02331446
The Effect of Different Volumes of Physical Exercise on the Immune System
A study testing Physical exercise intervention in people with Immune System Diseases and Oxidative Stress, run by Federal University of Pelotas.
Trial summary
The investigators will do an intervention on four groups of previously sedentary post-menopausal women which consists: group 1 - 30 minutes per day of physical protocol; group 2 - 50 minutes per day of physical protocol; group 3 - 70 minutes per day of physical protocol; group 4 - sedentary control women. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Immune System Diseases, Oxidative Stress
- What is being tested?
- Physical exercise intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to Sep 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Women have to be in the postmenopausal period, without physical disorders.
Who cannot join
- Women who answer positively to, at least, one of the issues of the PAR-Q instrument;
- Women with diabetes and/or cancer history;
- Women who underwent oophorectomy.
About this study
Official title: Dose-response Effects of Different Volumes of Structured Exercise in the Inflammatory and Oxidative Stress Parameters in Postmenopausal Women: a Randomized Clinical Trial
The investigators will do an intervention on four groups of previously sedentary post-menopausal women which consists: group 1 - 30 minutes per day of physical protocol; group 2 - 50 minutes per day of physical protocol; group 3 - 70 minutes per day of physical protocol; group 4 - sedentary control women. The protocol consists of three sessions per week of concurrent training (half session with aerobic training and the other part with weight training). Inflammatory and oxidative parameters will be analyzed and the investigators hypothesized that 90 minutes per week of concurrent training (group 1) will reduce the inflammatory parameters and the oxidative stress, and this improvements will be greater so much as the longer the sessions (a dose-response effect). The physical activity practiced out of the intervention will be controlled by a questionnaire (the commuting and leisure sections of the International Physical Activity Questionnaire) and the food intake by a 24-hour food recall.
Read the detailed description
The protocol will consist of an intervention based on concurrent training, for previously sedentary post-menopausal women divided on four groups: 1) control group; 2) 90 minutes of physical training per week; 3) 150 minutes of training per week; 4) 210 minutes of training per week.
The control group will be oriented to maintain their normal activity and habits and will not receive the intervention. The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training. The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training. The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.
The aerobic exercise will be performed on cycle-ergometers and the subjects will exercise between the levels 14 and 15 of Borg's scale of perceived exertion. The strength training will be performed on weight machines by a linear periodization, which will consist on a week of adaptation (series of 10 to 12 submaximal repetitions), next three weeks with series of 12 to 14 maximal repetitions, weeks five to eight with series of 10 to 12 maximal repetitions, weeks nine to twelve with series of eight to 10 maximal repetitions. Al participants will do the maximum number of series of strength training that the time permits.
The blood samples will be collected at the beginning of the study (week zero), at the middle (week six) and at the end (week 12). The subjects will fill a 24-hour food recall (to control the food intake) and the commuting and leisure sections of the International Physical Activity Questionnaire (to control the physical activity practiced out of the intervention).
- Conditions
- Immune System Diseases, Oxidative Stress
- Being tested
- Physical exercise intervention
- Medical subject headings
- Immune System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical exercise interventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | The control group will be oriented to maintain their normal activity and habits and will not receive the intervention. |
| 90 minutes per week | Experimental | The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training. Receives: Behavioral: Physical exercise intervention |
| 150 minutes per week | Experimental | The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training. Receives: Behavioral: Physical exercise intervention |
| 210 minutes per week | Experimental | The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training. Receives: Behavioral: Physical exercise intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Interleukin-6
Measured: Weeks 0, 6 and 12
Change in Adenosine Deaminase Activity
Measured: Weeks 0, 6 and 12
Change in Butyrylcholinesterase Activity
Measured: Weeks 0, 6 and 12
Change in Thiobarbituric Acid Reactive Substances
Measured: Weeks 0, 6 and 12
Change in Total Thiol Content
Measured: Weeks 0, 6 and 12
Change in Glutathione Peroxidase Activity
Measured: Weeks 0, 6 and 12
Change in Superoxide Dismutase Activity
Measured: Weeks 0, 6 and 12
Secondary outcomes (2)
Change in Performance in the Six-minute Walk Test
Measured: Weeks 0 and 12
Change in Handgrip Strength
Measured using a handgrip dynamometer and quantified in kilogram-force
Measured: Weeks 0 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2015 (estimated)
- Study startMar 2014
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Immune System DiseasesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Pelotas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matheus Pintanel Silva de Freitas, Federal University of Pelotas
- Investigators
- Matheus P Freitas, Principal investigator, Federal University of Pelotas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02331446
- Sponsor's protocol ID
- 27371214.4.0000.5313
- Acronym
- ProAFIM
- Status last verified
- Aug 2016
- First submitted
- 23 Dec 2014
- Last updated
- 29 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-response Effects of Different Volumes of Structured Exercise in the Inflammatory and Oxidative Stress Parameters in Postmenopausal Women: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02331446
- Acronym / sponsor ID
- ProAFIM / 27371214.4.0000.5313
- Conditions
- Immune System Diseases, Oxidative Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Federal University of PelotasUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 6 Jan 2015 (estimated)
- Results
- Posted 23 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will do an intervention on four groups of previously sedentary post-menopausal women which consists: group 1 - 30 minutes per day of physical protocol; group 2 - 50 minutes per day of physical protocol; group 3 - 70 minutes per day of physical protocol; group 4 - sedentary control women. The protocol consists of three sessions per week of concurrent training (half session with aerobic training and the other part with weight training). Inflammatory and oxidative parameters will be analyzed and the investigators hypothesized that 90 minutes per week of concurrent training (group 1) will reduce the inflammatory parameters and the oxidative stress, and this improvements will be greater so much as the longer the sessions (a dose-response effect). The physical activity practiced out of the intervention will be controlled by a questionnaire (the commuting and leisure sections of the International Physical Activity Questionnaire) and the food intake by a 24-hour food recall.
Detailed description
The protocol will consist of an intervention based on concurrent training, for previously sedentary post-menopausal women divided on four groups: 1) control group; 2) 90 minutes of physical training per week; 3) 150 minutes of training per week; 4) 210 minutes of training per week.
The control group will be oriented to maintain their normal activity and habits and will not receive the intervention. The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training. The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training. The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.
The aerobic exercise will be performed on cycle-ergometers and the subjects will exercise between the levels 14 and 15 of Borg's scale of perceived exertion. The strength training will be performed on weight machines by a linear periodization, which will consist on a week of adaptation (series of 10 to 12 submaximal repetitions), next three weeks with series of 12 to 14 maximal repetitions, weeks five to eight with series of 10 to 12 maximal repetitions, weeks nine to twelve with series of eight to 10 maximal repetitions. Al participants will do the maximum number of series of strength training that the time permits.
The blood samples will be collected at the beginning of the study (week zero), at the middle (week six) and at the end (week 12). The subjects will fill a 24-hour food recall (to control the food intake) and the commuting and leisure sections of the International Physical Activity Questionnaire (to control the physical activity practiced out of the intervention).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The control group will be oriented to maintain their normal activity and habits and will not receive the intervention. |
| 90 minutes per week | Experimental | Behavioral: Physical exercise interventionThe group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training. |
| 150 minutes per week | Experimental | Behavioral: Physical exercise interventionThe group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training. |
| 210 minutes per week | Experimental | Behavioral: Physical exercise interventionThe group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Women have to be in the postmenopausal period, without physical disorders.
Key exclusion criteria (3 listed)
- Women who answer positively to, at least, one of the issues of the PAR-Q instrument;
- Women with diabetes and/or cancer history;
- Women who underwent oophorectomy.
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 |
|---|---|---|
| Physical exercise intervention | Behavioural | 150 minutes per week, 210 minutes per week, 90 minutes per week |
Primary outcome
Change in Interleukin-6
Time frame: Weeks 0, 6 and 12
Change in Adenosine Deaminase Activity
Time frame: Weeks 0, 6 and 12
Change in Butyrylcholinesterase Activity
Time frame: Weeks 0, 6 and 12
Change in Thiobarbituric Acid Reactive Substances
Time frame: Weeks 0, 6 and 12
Change in Total Thiol Content
Time frame: Weeks 0, 6 and 12
Change in Glutathione Peroxidase Activity
Time frame: Weeks 0, 6 and 12
Change in Superoxide Dismutase Activity
Time frame: Weeks 0, 6 and 12
2 secondary outcomes
Change in Performance in the Six-minute Walk Test
Time frame: Weeks 0 and 12
Change in Handgrip Strength
Time frame: Weeks 0 and 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Matheus P Freitas principal investigator
Federal University of Pelotas
Questions about this trial
What is this clinical trial studying?
A study testing Physical exercise intervention in people with Immune System Diseases and Oxidative Stress, run by Federal University of Pelotas.
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 3 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 29 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 23 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Interleukin-6 (time frame: Weeks 0, 6 and 12). The study lists 7 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 29 Sep 2016.