Healthy Older AdultsNCT02346981
Resistance Training and Post-exercise Blood Pressure in Normotensive Older Women
A study testing Resistance training in people with Healthy Older Adults, run by Universidade Estadual de Londrina.
Trial summary
The purpose of the present study was to analyze the effect of 12 weeks of resistance training on post-exercise blood pressure (BP) and to to correlate the acute and chronic decrease in blood pressure (BP) following resistance training in normotensive older women. Read more about this study
- Who is it for?
- Ages 60 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Older Adults
- What is being tested?
- Resistance training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- Feb 2008to Jul 2008
- 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 60 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- normotensive female;
- aged 60-to-80 years old;
- nonsmokers;
- without diabetes, cardiac disease or renal dysfunction;
- not practicing regular physical activity over the six months preceding the beginning of the investigation;
- being free of any musculoskeletal or other disorders that might affect their ability to participate in the study,
Show all 9Show fewer
- should not be taking drugs with inotropic or chronotropic actions;
- should not be using hormonal replacement therapy;
- have no restriction for participation in physical exercise, after diagnostic, graded exercise stress test with 12-lead ECG.
Who cannot join
- insufficient attendance to the training sessions (< 85 % of the total sessions);
- unavailability of time to perform the evaluations
About this study
Official title: Chronic Resistance Training and Post-exercise Blood Pressure in Normotensive Older Women
The purpose of the present study was to analyze the effect of 12 weeks of resistance training on post-exercise blood pressure (BP) and to to correlate the acute and chronic decrease in blood pressure (BP) following resistance training in normotensive older women. Twenty-eight older women were randomly assigned to a training group (TG) or to a control group (CG). The TG underwent a resistance training program (8 exercises, 2 sets, 10-15 repetitions), while the CG performed stretching exercises (2 sets, 20 s each, 2 nonconsecutive days/week). Both groups performed the intervention for 12 weeks. At baseline and after intervention the subjects were submitted to two sessions: resistance exercise session and control session. In these sessions, BP was obtained in pre and post-sessions. Rest blood pressure were also measure at baseline and after 12 weeks of intervention.
Read the detailed description
Older (≥60 years) normotensive and physically inactive women were recruited. Women were randomized into training group (TG) or control group (CG) and submitted to 12 weeks of intervention. The intervention programs were divided into three phases: initial (first two weeks), intermediate (from week 3 to week 10) and final (last two weeks). The TG was submitted to a resistance training program that consisted of eight exercises performed in two sets of 10 to 15 repetitions, three times per week. The CG performed a stretching training program for the major muscle groups, in sessions of 30 minutes, twice a week. These interventions were maintained during the 12 weeks.
During initial and final phases subjects of both groups were submitted to two acute experimental sessions: resistance exercise and control, which were performed in random order. The resistance exercise session was similar to those performed during the resistance training program (i.e., 7 exercises, 2 sets, 10-15 repetitions). In the control session participants remained seated for 40 min. Before and after each session the BP parameters were obtained. The chronic effect of resistance training on post-exercise BP were assessed by analyzing the changes (∆) in BP after acute experimental sessions at initial and final phases. The correlation between acute and chronic responses of blood pressure following resistance training was analyses correlating the acute blood pressure observed in initial phase with the chronic effect of resistance training on rest blood pressure.
- Conditions
- Healthy Older Adults
- Being tested
- Resistance training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance trainingBehavioural
Supervised resistance training program was performed on three nonconsecutive days per week at morning period for 12 weeks. The resistance training program included eight exercises in two consecutive sets of 10-15 repetitions until moderate fatigue, except for crunch exercise which was performed on 20 to 30 repetitions without overload. The participants were instructed to perform repetitions at a ratio of 1:2 (concentric and eccentric phases, respectively). Subjects rested for 60- to 90-s between each set and for 2- to 3-min between each exercise. Each subject was individually supervised. Increases of 2-5 % for the upper limb exercises and 5-10 % for the lower limb exercises every time that subjects were able to complete 15 repetitions in both sets.
| Study group | Role | What they receive |
|---|---|---|
| Intervention gruop | Experimental | The intervention group was submitted to a resistance training program that consisted of eight exercises performed in two sets of 10 to 15 repetitions, three times per week. Receives: Behavioral: Resistance training |
| Control group | No intervention | The control group performed a stretching training program for the major muscle groups, in sessions of 30 minutes, twice a week |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in clinic blood pressure
Measured: baseline, 12 weeks
Secondary outcomes (1)
changes in post-exercise blood pressure
Measured: baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2015 (estimated)
- Study startFeb 2008
- Primary completionJun 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy Older AdultsStudies 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
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual de Londrina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aline Mendes Gerage, Universidade Estadual de Londrina
- Investigators
- Aline M Gerage, Master, Principal investigator, Universidade Estadual de LondrinaEdilson S Cyrino, Doctor, Study director, Universidade Estadual de Londrina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02346981
- Sponsor's protocol ID
- PIUEL2008
- Status last verified
- Jan 2015
- First submitted
- 20 Jan 2015
- Last updated
- 28 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Gerage AM, Ritti-Dias RM, do Nascimento MA, Pina FL, Goncalves CG, Sardinha LB, Cyrino ES. Chronic resistance training does not affect post-exercise blood pressure in normotensive older women: a randomized controlled trial. Age (Dordr). 2015 Jun;37(3):63. doi: 10.1007/s11357-015-9801-1. Epub 2015 Jun 6.
PubMed 26047957
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Resistance Training and Post-exercise Blood Pressure in Normotensive Older Women
- ClinicalTrials.gov ID
- NCT02346981
- Acronym / sponsor ID
- PIUEL2008
- Conditions
- Healthy Older Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Universidade Estadual de LondrinaUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 27 Jan 2015 (estimated)
- 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 purpose of the present study was to analyze the effect of 12 weeks of resistance training on post-exercise blood pressure (BP) and to to correlate the acute and chronic decrease in blood pressure (BP) following resistance training in normotensive older women. Twenty-eight older women were randomly assigned to a training group (TG) or to a control group (CG). The TG underwent a resistance training program (8 exercises, 2 sets, 10-15 repetitions), while the CG performed stretching exercises (2 sets, 20 s each, 2 nonconsecutive days/week). Both groups performed the intervention for 12 weeks. At baseline and after intervention the subjects were submitted to two sessions: resistance exercise session and control session. In these sessions, BP was obtained in pre and post-sessions. Rest blood pressure were also measure at baseline and after 12 weeks of intervention.
Detailed description
Older (≥60 years) normotensive and physically inactive women were recruited. Women were randomized into training group (TG) or control group (CG) and submitted to 12 weeks of intervention. The intervention programs were divided into three phases: initial (first two weeks), intermediate (from week 3 to week 10) and final (last two weeks). The TG was submitted to a resistance training program that consisted of eight exercises performed in two sets of 10 to 15 repetitions, three times per week. The CG performed a stretching training program for the major muscle groups, in sessions of 30 minutes, twice a week. These interventions were maintained during the 12 weeks.
During initial and final phases subjects of both groups were submitted to two acute experimental sessions: resistance exercise and control, which were performed in random order. The resistance exercise session was similar to those performed during the resistance training program (i.e., 7 exercises, 2 sets, 10-15 repetitions). In the control session participants remained seated for 40 min. Before and after each session the BP parameters were obtained. The chronic effect of resistance training on post-exercise BP were assessed by analyzing the changes (∆) in BP after acute experimental sessions at initial and final phases. The correlation between acute and chronic responses of blood pressure following resistance training was analyses correlating the acute blood pressure observed in initial phase with the chronic effect of resistance training on rest blood pressure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention gruop | Experimental | Behavioral: Resistance trainingThe intervention group was submitted to a resistance training program that consisted of eight exercises performed in two sets of 10 to 15 repetitions, three times per week. |
| Control group | No intervention | –The control group performed a stretching training program for the major muscle groups, in sessions of 30 minutes, twice a week |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- normotensive female;
- aged 60-to-80 years old;
- nonsmokers;
- without diabetes, cardiac disease or renal dysfunction;
- not practicing regular physical activity over the six months preceding the beginning of the investigation;
Key exclusion criteria (2 listed)
- insufficient attendance to the training sessions (< 85 % of the total sessions);
- unavailability of time to perform the evaluations
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 |
|---|---|---|
| Resistance trainingSupervised resistance training program was performed on three nonconsecutive days per week at morning period for 12 weeks. The resistance training program included eight exercises in two consecutive sets of 10-15 repetitions until moderate fatigue, except for crunch exercise which was performed on 20 to 30 repetitions without overload. The participants were instructed to perform repetitions at a ratio of 1:2 (concentric and eccentric phases, respectively). Subjects rested for 60- to 90-s between each set and for 2- to 3-min between each exercise. Each subject was individually supervised. Increases of 2-5 % for the upper limb exercises and 5-10 % for the lower limb exercises every time that subjects were able to complete 15 repetitions in both sets. | Behavioural | Intervention gruop |
Primary outcome
changes in clinic blood pressure
Time frame: baseline, 12 weeks
1 secondary outcome
changes in post-exercise blood pressure
Time frame: baseline, 12 weeks
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 28 Jan 2015.
- Derived from this study: PubMed 26047957Gerage AM, Ritti-Dias RM, do Nascimento MA, Pina FL, Goncalves CG, Sardinha LB, Cyrino ES. Chronic resistance training does not affect post-exercise blood pressure in normotensive older women: a randomized controlled trial. Age (Dordr). 2015 Jun;37(3):63. doi: 10.1007/s11357-015-9801-1. Epub 2015 Jun 6.
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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.
Aline M Gerage, Master principal investigator
Universidade Estadual de Londrina
Edilson S Cyrino, Doctor study director
Universidade Estadual de Londrina
Questions about this trial
What is this clinical trial studying?
A study testing Resistance training in people with Healthy Older Adults, run by Universidade Estadual de Londrina.
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 9 inclusion and 2 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 28 Jan 2015. 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?
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?
changes in clinic blood pressure (time frame: baseline, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02346981, which also lists 1 linked publication.
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 28 Jan 2015.