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The Effect of Different Volumes of Physical Exercise on the Immune System (ProAFIM)

Primary Purpose

Immune System Diseases, Oxidative Stress

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Physical exercise intervention
Sponsored by
Federal University of Pelotas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Immune System Diseases

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women have to be in the postmenopausal period, without physical disorders.

Exclusion Criteria:

  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    No Intervention

    Experimental

    Experimental

    Experimental

    Arm Label

    Control

    90 minutes per week

    150 minutes per week

    210 minutes per week

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Change in Interleukin-6
    Change in Adenosine Deaminase Activity
    Change in Butyrylcholinesterase Activity
    Change in Thiobarbituric Acid Reactive Substances
    Change in Total Thiol Content
    Change in Glutathione Peroxidase Activity
    Change in Superoxide Dismutase Activity

    Secondary Outcome Measures

    Change in Performance in the Six-minute Walk Test
    Change in Handgrip Strength
    Measured using a handgrip dynamometer and quantified in kilogram-force

    Full Information

    First Posted
    December 23, 2014
    Last Updated
    August 22, 2016
    Sponsor
    Federal University of Pelotas
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02331446
    Brief Title
    The Effect of Different Volumes of Physical Exercise on the Immune System
    Acronym
    ProAFIM
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2014 (undefined)
    Primary Completion Date
    September 2014 (Actual)
    Study Completion Date
    September 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Federal University of Pelotas

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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. 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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Immune System Diseases, Oxidative Stress

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    42 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
    Arm Title
    90 minutes per week
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    150 minutes per week
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    210 minutes per week
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Physical exercise intervention
    Primary Outcome Measure Information:
    Title
    Change in Interleukin-6
    Time Frame
    Weeks 0, 6 and 12
    Title
    Change in Adenosine Deaminase Activity
    Time Frame
    Weeks 0, 6 and 12
    Title
    Change in Butyrylcholinesterase Activity
    Time Frame
    Weeks 0, 6 and 12
    Title
    Change in Thiobarbituric Acid Reactive Substances
    Time Frame
    Weeks 0, 6 and 12
    Title
    Change in Total Thiol Content
    Time Frame
    Weeks 0, 6 and 12
    Title
    Change in Glutathione Peroxidase Activity
    Time Frame
    Weeks 0, 6 and 12
    Title
    Change in Superoxide Dismutase Activity
    Time Frame
    Weeks 0, 6 and 12
    Secondary Outcome Measure Information:
    Title
    Change in Performance in the Six-minute Walk Test
    Time Frame
    Weeks 0 and 12
    Title
    Change in Handgrip Strength
    Description
    Measured using a handgrip dynamometer and quantified in kilogram-force
    Time Frame
    Weeks 0 and 12
    Other Pre-specified Outcome Measures:
    Title
    Change in Body Mass Index
    Time Frame
    Weeks 0 and 12
    Title
    Change in Minutes Per Week of Physical Activity Out of Intervention
    Description
    Measured by the commuting and leisure sections of the International Physical Activity Questionnaire
    Time Frame
    Week 0 and 12
    Title
    Change in Calories Intake
    Description
    Measured by a 24-hour food recall and quantified in calories
    Time Frame
    Weeks 0 and 12
    Title
    Educational Level
    Description
    Measured by a questionnaire and quantified categorically in: Incomplete primary school; Primary school; Incomplete high school; High school; Incomplete higher education; Higher education. The number of baseline participants is not consistent with number provided in the Participant Flow module because two of the beginning participants did not arrived on the first data collection. Due to this, these participants (one of the 90 min/week, and other of the 150 min/week group) were lost to follow-up before the baseline data collection.
    Time Frame
    Week 0
    Title
    Household Income
    Description
    Measured by a questionnaire and quantified by the income of all persons in the participant's home. The number of baseline participants is not consistent with number provided in the Participant Flow module because two of the beginning participants did not arrived on the first data collection. Due to this, these participants (one of the 90 min/week, and other of the 150 min/week group) were lost to follow-up before the baseline data collection.
    Time Frame
    Week 0
    Title
    Age
    Description
    The number of baseline participants is not consistent with number provided in the Participant Flow module because two of the beginning participants did not arrived on the first data collection. Due to this, these participants (one of the 90 min/week, and other of the 150 min/week group) were lost to follow-up before the baseline data collection.
    Time Frame
    Week 0
    Title
    Chronic Use of Medication
    Description
    Measured by a questionnaire and quantified categorically in: No; Yes. This variable refers to a chronic use of any medication. The number of baseline participants is not consistent with number provided in the Participant Flow module because two of the beginning participants did not arrived on the first data collection. Due to this, these participants (one of the 90 min/week, and other of the 150 min/week group) were lost to follow-up before the baseline data collection.
    Time Frame
    Week 0

    10. Eligibility

    Sex
    Female
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Women have to be in the postmenopausal period, without physical disorders. Exclusion Criteria: 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Matheus P Freitas
    Organizational Affiliation
    Federal University of Pelotas
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    The Effect of Different Volumes of Physical Exercise on the Immune System

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