AgingNCT03443375
Exercise Periodization and Older Adults
A study testing Physical exercise in people with Aging and Physical Activity, run by University of Campinas, Brazil.
Trial summary
The present study aimed at investigating the effects of two different resistance training protocols - nonperiodized (NP) and daily undulating periodization (DUP) - on hemodynamic, morphofunctional and cognitive parameters of robust older women. Read more about this study
- Who is it for?
- Ages 60 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Aging, Physical Activity, Sarcopenia
- What is being tested?
- Physical exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Dec 2015
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged ≥60 years;
- Female;
- Not having been part of a systematic program of physical exercises in the last 6 months;
- MEEM score >19 points;
- Kihon checklist score >10 points;
- Capacity to perform the basic and instrumental activities of daily living according to Katz and Pfeffer indexes;
- Self-reported good memory;
- Complete all measurements.
Who cannot join
- Changes on antihypertensive medication in the past 6 months prior to inclusion in the study;
- Cardiovascular disease (i.e., acute myocardial infarction, stroke, peripheral arterial disease, and transient ischemic disease)
- Metabolic disease (i.e., diabetes mellitus type I or II), pulmonary disease (i.e., emphysema)
- Neurological and/or psychiatric disease (i.e., Parkinson's or Alzheimer's disease)
- Skeletal muscle disorders
- Comorbidities associated with greater risk of falls
- Recent history of smoking or alcohol abuse
- Hormone replacement therapy and/or psychotropic drugs.
About this study
Official title: Effects of Resistance Training Periodization on Hemodynamic, Morphofunctional and Cognitive Parameters of Robust Older Women.
The present study aimed at investigating the effects of two different resistance training protocols - nonperiodized (NP) and daily undulating periodization (DUP) - on hemodynamic, morphofunctional and cognitive parameters of robust older women. Methods: Forty-two older women were randomized allocated into one of the three experimental groups: NP, DUP, and control group (CG). Evaluations of the hemodynamic, morphofunctional and cognitive parameters occurred before, during and after six months. The exercise groups performed the program of exercise twice a week over 22 weeks. In NP, the two weekly sessions were based on 3 sets of 8-10 repetitions at a difficult intensity. However, in DUP, a power exercise session based on 3 sets of 8-10 repetitions at a moderate intensity was added in the first session of the week.
- Conditions
- Aging, Physical Activity, Sarcopenia, Cognitive Decline, Blood Pressure, Physical Disability
- Being tested
- Physical exercise
- Keywords
- Older adults, Physical function, Muscle mass, Short-term memory, Executive function, Blood Pressure, Resistance training, Exercise training, Periodization
- Medical subject headings
- Motor Activity, Sarcopenia, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical exerciseOther
The interventions proposed in the present trial were based on a safe and well-established exercise training program
| Study group | Role | What they receive |
|---|---|---|
| Nonperiodized resistance training | Experimental | The Nonperiodized group performed was an intervention based on resistance exercise program with a constant intensity. Receives: Other: Physical exercise |
| Daily undulating periodized | Experimental | The Daily undulating periodized program was an intervention based on daily alterations on exercise load. . Receives: Other: Physical exercise |
| Control group | No intervention | The control group remained their regular habits of life during all study period, without engaging in physical exercise programs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in transfer capacity in seconds
TUG performance
Measured: 6 months
Secondary outcomes (4)
Changes in fat-free mass in kg
Fat-free mass
Measured: 6 months
Changes in overall cognitive capacity in points
MEEM
Measured: 6 months
Changes in blood pressure in mmHg
Blood Pressure
Measured: 6 months
Changes in shor-term memory in points
Memory
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2018
- Study startJan 2015
- Primary completionDec 2015
- Study completionDec 2015
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 AgingStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hélio José Coelho Júnior, University of Campinas, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03443375
- Sponsor's protocol ID
- 835.733
- Status last verified
- Feb 2018
- First submitted
- 8 Feb 2018
- Last updated
- 23 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Coelho-Junior HJ, Goncalves IO, Camara NOS, Cenedeze MA, Bacurau RF, Asano RY, Santana J, Caperuto E, Uchida MC, Rodrigues B. Non-periodized and Daily Undulating Periodized Resistance Training on Blood Pressure of Older Women. Front Physiol. 2018 Nov 27;9:1525. doi: 10.3389/fphys.2018.01525. eCollection 2018.
PubMed 30542289
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Resistance Training Periodization on Hemodynamic, Morphofunctional and Cognitive Parameters of Robust Older Women.
- ClinicalTrials.gov ID
- NCT03443375
- Acronym / sponsor ID
- 835.733
- Conditions
- Aging, Physical Activity, Sarcopenia, Cognitive Decline, Blood Pressure, Physical Disability
- Keywords
- Older adults, Physical function, Muscle mass, Short-term memory, Executive function, Blood Pressure, Resistance training, Exercise training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 23 Feb 2018 (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 present study aimed at investigating the effects of two different resistance training protocols - nonperiodized (NP) and daily undulating periodization (DUP) - on hemodynamic, morphofunctional and cognitive parameters of robust older women. Methods: Forty-two older women were randomized allocated into one of the three experimental groups: NP, DUP, and control group (CG). Evaluations of the hemodynamic, morphofunctional and cognitive parameters occurred before, during and after six months. The exercise groups performed the program of exercise twice a week over 22 weeks. In NP, the two weekly sessions were based on 3 sets of 8-10 repetitions at a difficult intensity. However, in DUP, a power exercise session based on 3 sets of 8-10 repetitions at a moderate intensity was added in the first session of the week.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nonperiodized resistance training | Experimental | Other: Physical exerciseThe Nonperiodized group performed was an intervention based on resistance exercise program with a constant intensity. |
| Daily undulating periodized | Experimental | Other: Physical exerciseThe Daily undulating periodized program was an intervention based on daily alterations on exercise load. . |
| Control group | No intervention | –The control group remained their regular habits of life during all study period, without engaging in physical exercise programs. |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged ≥60 years;
- Female;
- Not having been part of a systematic program of physical exercises in the last 6 months;
- MEEM score >19 points;
- Kihon checklist score >10 points;
Key exclusion criteria (8 listed)
- Changes on antihypertensive medication in the past 6 months prior to inclusion in the study;
- Cardiovascular disease (i.e., acute myocardial infarction, stroke, peripheral arterial disease, and transient ischemic disease)
- Metabolic disease (i.e., diabetes mellitus type I or II), pulmonary disease (i.e., emphysema)
- Neurological and/or psychiatric disease (i.e., Parkinson's or Alzheimer's disease)
- Skeletal muscle disorders
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 exerciseThe interventions proposed in the present trial were based on a safe and well-established exercise training program | Other | Daily undulating periodized, Nonperiodized resistance training |
Primary outcome
Changes in transfer capacity in seconds
Time frame: 6 months
TUG performance
4 secondary outcomes
Changes in fat-free mass in kg
Time frame: 6 months
Changes in overall cognitive capacity in points
Time frame: 6 months
Changes in blood pressure in mmHg
Time frame: 6 months
Changes in shor-term memory in points
Time frame: 6 months
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 23 Feb 2018.
- Derived from this study: PubMed 30542289Coelho-Junior HJ, Goncalves IO, Camara NOS, Cenedeze MA, Bacurau RF, Asano RY, Santana J, Caperuto E, Uchida MC, Rodrigues B. Non-periodized and Daily Undulating Periodized Resistance Training on Blood Pressure of Older Women. Front Physiol. 2018 Nov 27;9:1525. doi: 10.3389/fphys.2018.01525. eCollection 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Physical exercise in people with Aging and Physical Activity, run by University of Campinas, Brazil.
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 8 inclusion and 8 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 23 Feb 2018. 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 transfer capacity in seconds (time frame: 6 months). 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 NCT03443375, 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 23 Feb 2018.