Aging DisorderNCT03320005
EFFECTS OF RESISTANCE TRAINING IN ELDERLY
A study testing Resistance training group in people with Aging Disorder, run by Daysi Tobelem.
Trial summary
This comes from a non-randomized clinical trial, which aims to check on elderly women the effects of a program of resistance training (TR) in physical performance, in respiratory functional capacity, on health and quality of life. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Aging Disorder
- What is being tested?
- Resistance training group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Jan 2018
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 60 year old or more
- Do not have cardiac or respiratory diseases
- neurological, Musculoskeletal and other diseases preventing the practice of exercises
- not being a smoker; agree to participate in the study and signed an informed consent (IC); in the last six months preceding the evaluation did not have participated in physical activity program with the aim of improving physical performance.
Who cannot join
- Difficult to complete the tasks
- Acute diseases
- Refuse to continue the program
About this study
Official title: EFFECTS OF RESISTANCE TRAINING ON THE PHYSICAL AND FUNCTIONAL RESPIRATORY PERFORMANCE OF ELDERLY
This comes from a non-randomized clinical trial, which aims to check on elderly women the effects of a program of resistance training (TR) in physical performance, in respiratory functional capacity, on health and quality of life.
Read the detailed description
Will be measured the strength of the respiratory muscles (Mip and Mep), peak expiratory flow (Peak-Flow), thoracic movements and abdominal movements, distance traveled in Incremental Shuttle Walk Test, grip strength manual, pulmonary leukocytes, biochemical parameters and indicators of quality of life and physical activity through the WHOQOL-old and IPAQ-short. The data will be tested against the distribution of the Gauss curve, by the shapiro-wilk test and, if they have a normal distribution (parametric) are expressed as mean and standard deviation, if not submit normal (non parametric) distribution will be expressed as median or range interquartílico. The first chance to compare the evolution of the group studied, will be applied to two-way ANOVA. If the distribution is abnormal, it will apply Mann-Whitney test. The multiple regression test will be used to compare the Mip and Mep with variables with the Peak-Flow, Thoracoabdominal mobility, distance traveled, immune competence, physical fitness and quality of life in the groups studied.
- Conditions
- Aging Disorder
- Being tested
- Resistance training group
- Keywords
- respiratory performance, quality of life, physical performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance training groupOther
Resistive exercises for legs and arms
| Study group | Role | What they receive |
|---|---|---|
| ResistanceTraining Group | Active comparator | The RT program has the following features: 05 classes performing two weekly sessions; day shift; sessions with maximum duration of 1 (one) hour; 02 series; 08 to 12 repetitions; interval between sets of 01 to 02 minutes; exercises: bench press, seated leg press 45°, pull forward, Earth, rowing standing calf standing, power lifting, abdominal and development. Receives: Other: Resistance training group |
| Non training group | No intervention | sedentary elderly |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical performance
distance traveled on ISWT
Measured: Change from Baseline at 24 weeks
Secondary outcomes (3)
quality of life
quality of life (WHOQOL-old)
Measured: Change from Baseline at 24 weeks
respiratory muscle strength
respiratory pressures
Measured: Change from Baseline at 24 weeks
Hand grip
Hand grip test
Measured: Change from Baseline at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2017
- Study startJan 2017
- Primary completionDec 2017 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aging DisorderStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daysi Tobelem
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Daysi Tobelem, University of Nove de Julho
- Investigators
- Dirceu Costa, PhD, Study chair, Nove de Julho University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03320005
- Sponsor's protocol ID
- Resist protocol
- Status last verified
- Oct 2017
- First submitted
- 7 Aug 2017
- Last updated
- 24 Oct 2017
- 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 24 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTS OF RESISTANCE TRAINING ON THE PHYSICAL AND FUNCTIONAL RESPIRATORY PERFORMANCE OF ELDERLY
- ClinicalTrials.gov ID
- NCT03320005
- Acronym / sponsor ID
- Resist protocol
- Conditions
- Aging Disorder
- Keywords
- respiratory performance, quality of life, physical performance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Daysi TobelemUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 24 Oct 2017 (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.
This comes from a non-randomized clinical trial, which aims to check on elderly women the effects of a program of resistance training (TR) in physical performance, in respiratory functional capacity, on health and quality of life.
Detailed description
Will be measured the strength of the respiratory muscles (Mip and Mep), peak expiratory flow (Peak-Flow), thoracic movements and abdominal movements, distance traveled in Incremental Shuttle Walk Test, grip strength manual, pulmonary leukocytes, biochemical parameters and indicators of quality of life and physical activity through the WHOQOL-old and IPAQ-short. The data will be tested against the distribution of the Gauss curve, by the shapiro-wilk test and, if they have a normal distribution (parametric) are expressed as mean and standard deviation, if not submit normal (non parametric) distribution will be expressed as median or range interquartílico. The first chance to compare the evolution of the group studied, will be applied to two-way ANOVA. If the distribution is abnormal, it will apply Mann-Whitney test. The multiple regression test will be used to compare the Mip and Mep with variables with the Peak-Flow, Thoracoabdominal mobility, distance traveled, immune competence, physical fitness and quality of life in the groups studied.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ResistanceTraining Group | Active comparator | Other: Resistance training groupThe RT program has the following features: 05 classes performing two weekly sessions; day shift; sessions with maximum duration of 1 (one) hour; 02 series; 08 to 12 repetitions; interval between sets of 01 to 02 minutes; exercises: bench press, seated leg press 45°, pull forward, Earth, rowing standing calf standing, power lifting, abdominal and development. |
| Non training group | No intervention | –sedentary elderly |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 60 year old or more
- Do not have cardiac or respiratory diseases
- neurological, Musculoskeletal and other diseases preventing the practice of exercises
- not being a smoker; agree to participate in the study and signed an informed consent (IC); in the last six months preceding the evaluation did not have participated in physical activity program with the aim of improving physical performance.
Key exclusion criteria (3 listed)
- Difficult to complete the tasks
- Acute diseases
- Refuse to continue the program
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 training groupResistive exercises for legs and arms | Other | ResistanceTraining Group |
Primary outcome
Physical performance
Time frame: Change from Baseline at 24 weeks
distance traveled on ISWT
3 secondary outcomes
quality of life
Time frame: Change from Baseline at 24 weeks
respiratory muscle strength
Time frame: Change from Baseline at 24 weeks
Hand grip
Time frame: Change from Baseline at 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2017.
- 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.
Dirceu Costa, PhD study chair
Nove de Julho University
Questions about this trial
What is this clinical trial studying?
A study testing Resistance training group in people with Aging Disorder, run by Daysi Tobelem.
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 4 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: status not confirmed, as of the sponsor's last update on 24 Oct 2017. 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?
Results are not available in the source record.
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?
Physical performance (time frame: Change from Baseline at 24 weeks). 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 24 Oct 2017.