ElderlyNCT02976506
Unsupervised Physical Activity in Elderly
A study testing Unsupervised exercise program and Physical fitness and quality of life in people with Elderly and Hypertension, run by Universidade Federal de Goias at 1 site in Brazil.
Trial summary
To evaluate safety and the effects of a unsupervised physical activity program (USPAP) over blood pressure (BP), physical fitness (PF) and quality of life (QL) of elderly hypertensive patients. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Elderly, Hypertension, Physical Conditioning
- What is being tested?
- Unsupervised exercise program and Physical fitness and quality of life
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2014to May 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
The inclusion criteria were:
- 60 years old or more, stable BP on the last three months, no changes on pharmacological treatment over the last six months and a sedentary behavior (non-participation in any kind of physical activity for at least 2 months).
The exclusion criteria considered were:
- uncontrolled diabetes
- congestive heart failure
- acute myocardial infarction in the last six months
- stroke in the last six months or under rehabilitation
- previously diagnosed chronic renal failure
- acute infectious diseases
- recent systemic or pulmonary embolism
- pulmonary hypertension
- BP higher than 159 x 99 mmHg
- neuromuscular
- musculoskeletal or articular disorders diagnosed and not treated
- clinical evaluation restraining PA
- any situation preventing the patient from walk. Those criteria were verified in patients' medical charts.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety of an Unsupervised Physical Activity Program and Effects Over Blood Pressure, Physical Fitness and Quality of Life of Elderly Hypertensive Patients
To evaluate safety and the effects of a unsupervised physical activity program (USPAP) over blood pressure (BP), physical fitness (PF) and quality of life (QL) of elderly hypertensive patients.
Read the detailed description
The present study was approved by the Human and Animal Ethics Committee of the institution and the participants were only randomized to participate after having signed the informed consent form.
A population of elderly hypertensive patients registered at a reference center for hypertension treatment was selected. The sample size was calculated considering a test power of 80% with significance level of 5% and estimating a difference to be observed within the BP values of 7 mmHg for systolic blood pressure (SBP) and 4 mmHg for diastolic blood pressure (DBP). The sample calculated was 25 participants in each group being selected 20% more in case of losses.
An electronic chart was created with numbers for the patients that were randomized into control (CG) and intervention groups (IG).
The IG was included in an USPAP and the control group was kept under the usual care of the service that includes orientation to perform PA according to the World Health Organization recommendations.
Before the beginning of the protocol clinical and laboratorial data collected included: weight, height, waist circumference, fasting glucose, hemoglobin A1C and lipid profile.
In addition to that health-related quality of life was assessed with the Short Form 36-item Health Survey (SF-36). The SF-36 Questionnaire includes one multi-item scale that assesses eight health concepts: 1) functional capacity; 2) physical aspects; 3) pain; 4) general health status; 5) vitality; 6) social aspects; 7) emotional aspects; and 8) mental health. The score of each health concept ranges from 0 to 100, in which zero means the worst general health state and one hundred the best health state.
All patients underwent physical tests to evaluate their physical fitness: cardiorespiratory fitness test (Cooper Test) and abdominal resistance test. Patients were classified according to the Physical Aptitude Classification Tables for Users of Public Parks.
The BP was assessed with office BP measurements using OMRON - HEM 705 CP® semi-automatic devices according to the VI Brazilian Hypertension Guidelines (BHG). Home blood pressure was also performed following the same technics of office measurements and according to the III Brazilian Guidelines of Home Blood Pressure Monitoring with 3 measurements in the morning fasting and 3 at night before dinner in four consecutive days.
The physical activity prescriptions were individualized so that the patients would have no doubts regarding execution when performing the exercise without the presence of the prescribing professional. The prescribed physical activity was aerobic and walking was the chosen one. The activity was prescribed in a planned, structured and repetitive way aiming to maintain or improve one or more components of physical fitness. To achieve those goals patients attended to 2 supervised sessions that took place in a one week period in non-consecutive days. They were instructed to perform training at least 3 times a week during 30 minutes or more with a moderate intensity of 40 to 60% of their reserve heart rate which mean walking slightly breathless but being able to pronounce complete phrases according to the VI BHG recommendations. The total number of sessions prescribed was 36 throughout the 12 weeks. The minimum of 30 sessions was needed so the results could be validated.
Health educational strategies were used simultaneously to data collection to improve adherence of both groups. Motivational actions were used specific for the IG. Weekly phone calls were carried out to the IG in order to know about the number of sessions performed that week, the duration of the practice and the total number of steps of each session. All participants received a pedometer and a diary to register activities.
Safety was assessed considering: need to interrupt training due to lesions, falls, incapacitating pain or acute events related to training that would require medical assistance.
After 12 weeks all participants were reevaluated and all procedures were repeated to evaluate the effects of the intervention.
Data collected was analyzed with software Statistical Package of Social Science, version 23.0, Chicago, USA. Qualitative variables were presented in absolute numbers and percentages with the comparison between them being made with Qui Square Test or Exact Fisher Test. Proportion comparison in the groups was performed applying Wilcoxon Test. Quantitative variables were initially analyzed in terms of its distribution with Shapiro-Wilk test. Mean variables comparison was performed with T-Student test for paired and unpaired samples. The results were presented as mean values and standard deviation and p value < 0,05 was considered significant.
- Conditions
- Elderly, Hypertension, Physical Conditioning
- Being tested
- Unsupervised exercise program, Physical fitness and quality of life
- Medical subject headings
- Hypertension, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unsupervised exercise programBehavioural
Also called interference on blood pressure
Both control and intervention group undergo clinical evaluation, and anthropometric measurements, blood pressure (casual and ambulatory blood pressure monitoring), physical and laboratorial tests, and the assesment of Quality of Life by Questionnaire SF-36 were done at the beginning and the end of the study.After a period of 12 weeks of unsupervised walking program in which participants were asked to do it three times a week at least, at a moderate intensity (40 to < 60% of heart rate reserve), all participants underwent a complete re-evaluation to compare the results obtained with the proposed program. Data were analyzed using SPPS, v.23.0.
Physical fitness and quality of lifeBehavioural
Both control and intervention group undergo clinical evaluation, and anthropometric measurements, blood pressure (casual and ambulatory blood pressure monitoring), physical and laboratorial tests, and the assesment of Quality of Life by Questionnaire SF-36 were done at the beginning and the end of the study.After a period of 12 weeks of unsupervised walking program in which participants were asked to do it three times a week at least, at a moderate intensity (40 to < 60% of heart rate reserve), all participants underwent a complete re-evaluation to compare the results obtained with the proposed program. Data were analyzed using SPPS, v.23.0.
| Study group | Role | What they receive |
|---|---|---|
| Unsupervised exercise program | Experimental | To verify the interference of an unsupervised exercise program on blood pressure, physical fitness, quality of life and safety in elderly hypertensive patients. Participants were divided into the study group or control group Receives: Behavioral: Unsupervised exercise program |
| Physical fitness and quality of life | Experimental | To verify the interference of a walking program on physical fitness and quality of life. Receives: Behavioral: Physical fitness and quality of life |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower Blood Pressure and or keeping it under control
Measured: 12 weeks
Secondary outcomes (3)
Improve Cardiorespiratory fitness.
Cooper Test (before and after the intervention).
Measured: 12 weeks
Improve abdominal strength.
Abdominal resistance test before and after the intervention.
Measured: 12 weeks
Quality of life
SF-36 questionnaire before and after the intervention
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study startMar 2014
- Primary completionMar 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderlyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Goias
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patricia Silva Carneiro, Universidade Federal de Goias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02976506
- Sponsor's protocol ID
- 30847614.6.0000.5078
- Status last verified
- Nov 2016
- First submitted
- 14 Nov 2016
- Last updated
- 29 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: OPEN ACCESS
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of an Unsupervised Physical Activity Program and Effects Over Blood Pressure, Physical Fitness and Quality of Life of Elderly Hypertensive Patients
- ClinicalTrials.gov ID
- NCT02976506
- Acronym / sponsor ID
- 30847614.6.0000.5078
- Conditions
- Elderly, Hypertension, Physical Conditioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universidade Federal de GoiasUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 29 Nov 2016 (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.
To evaluate safety and the effects of a unsupervised physical activity program (USPAP) over blood pressure (BP), physical fitness (PF) and quality of life (QL) of elderly hypertensive patients.
Detailed description
The present study was approved by the Human and Animal Ethics Committee of the institution and the participants were only randomized to participate after having signed the informed consent form.
A population of elderly hypertensive patients registered at a reference center for hypertension treatment was selected. The sample size was calculated considering a test power of 80% with significance level of 5% and estimating a difference to be observed within the BP values of 7 mmHg for systolic blood pressure (SBP) and 4 mmHg for diastolic blood pressure (DBP). The sample calculated was 25 participants in each group being selected 20% more in case of losses.
An electronic chart was created with numbers for the patients that were randomized into control (CG) and intervention groups (IG).
The IG was included in an USPAP and the control group was kept under the usual care of the service that includes orientation to perform PA according to the World Health Organization recommendations.
Before the beginning of the protocol clinical and laboratorial data collected included: weight, height, waist circumference, fasting glucose, hemoglobin A1C and lipid profile.
In addition to that health-related quality of life was assessed with the Short Form 36-item Health Survey (SF-36). The SF-36 Questionnaire includes one multi-item scale that assesses eight health concepts: 1) functional capacity; 2) physical aspects; 3) pain; 4) general health status; 5) vitality; 6) social aspects; 7) emotional aspects; and 8) mental health. The score of each health concept ranges from 0 to 100, in which zero means the worst general health state and one hundred the best health state.
All patients underwent physical tests to evaluate their physical fitness: cardiorespiratory fitness test (Cooper Test) and abdominal resistance test. Patients were classified according to the Physical Aptitude Classification Tables for Users of Public Parks.
The BP was assessed with office BP measurements using OMRON - HEM 705 CP® semi-automatic devices according to the VI Brazilian Hypertension Guidelines (BHG). Home blood pressure was also performed following the same technics of office measurements and according to the III Brazilian Guidelines of Home Blood Pressure Monitoring with 3 measurements in the morning fasting and 3 at night before dinner in four consecutive days.
The physical activity prescriptions were individualized so that the patients would have no doubts regarding execution when performing the exercise without the presence of the prescribing professional. The prescribed physical activity was aerobic and walking was the chosen one. The activity was prescribed in a planned, structured and repetitive way aiming to maintain or improve one or more components of physical fitness. To achieve those goals patients attended to 2 supervised sessions that took place in a one week period in non-consecutive days. They were instructed to perform training at least 3 times a week during 30 minutes or more with a moderate intensity of 40 to 60% of their reserve heart rate which mean walking slightly breathless but being able to pronounce complete phrases according to the VI BHG recommendations. The total number of sessions prescribed was 36 throughout the 12 weeks. The minimum of 30 sessions was needed so the results could be validated.
Health educational strategies were used simultaneously to data collection to improve adherence of both groups. Motivational actions were used specific for the IG. Weekly phone calls were carried out to the IG in order to know about the number of sessions performed that week, the duration of the practice and the total number of steps of each session. All participants received a pedometer and a diary to register activities.
Safety was assessed considering: need to interrupt training due to lesions, falls, incapacitating pain or acute events related to training that would require medical assistance.
After 12 weeks all participants were reevaluated and all procedures were repeated to evaluate the effects of the intervention.
Data collected was analyzed with software Statistical Package of Social Science, version 23.0, Chicago, USA. Qualitative variables were presented in absolute numbers and percentages with the comparison between them being made with Qui Square Test or Exact Fisher Test. Proportion comparison in the groups was performed applying Wilcoxon Test. Quantitative variables were initially analyzed in terms of its distribution with Shapiro-Wilk test. Mean variables comparison was performed with T-Student test for paired and unpaired samples. The results were presented as mean values and standard deviation and p value < 0,05 was considered significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unsupervised exercise program | Experimental | Behavioral: Unsupervised exercise programTo verify the interference of an unsupervised exercise program on blood pressure, physical fitness, quality of life and safety in elderly hypertensive patients. Participants were divided into the study group or control group |
| Physical fitness and quality of life | Experimental | Behavioral: Physical fitness and quality of lifeTo verify the interference of a walking program on physical fitness and quality of life. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Unsupervised exercise programAlso: interference on blood pressureBoth control and intervention group undergo clinical evaluation, and anthropometric measurements, blood pressure (casual and ambulatory blood pressure monitoring), physical and laboratorial tests, and the assesment of Quality of Life by Questionnaire SF-36 were done at the beginning and the end of the study.After a period of 12 weeks of unsupervised walking program in which participants were asked to do it three times a week at least, at a moderate intensity (40 to < 60% of heart rate reserve), all participants underwent a complete re-evaluation to compare the results obtained with the proposed program. Data were analyzed using SPPS, v.23.0. | Behavioural | Unsupervised exercise program |
| Physical fitness and quality of lifeBoth control and intervention group undergo clinical evaluation, and anthropometric measurements, blood pressure (casual and ambulatory blood pressure monitoring), physical and laboratorial tests, and the assesment of Quality of Life by Questionnaire SF-36 were done at the beginning and the end of the study.After a period of 12 weeks of unsupervised walking program in which participants were asked to do it three times a week at least, at a moderate intensity (40 to < 60% of heart rate reserve), all participants underwent a complete re-evaluation to compare the results obtained with the proposed program. Data were analyzed using SPPS, v.23.0. | Behavioural | Physical fitness and quality of life |
Primary outcome
Lower Blood Pressure and or keeping it under control
Time frame: 12 weeks
3 secondary outcomes
Improve Cardiorespiratory fitness.
Time frame: 12 weeks
Improve abdominal strength.
Time frame: 12 weeks
Quality of life
Time frame: 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 29 Nov 2016.
- Individual participant dataSharing planned: Undecided. OPEN ACCESS
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unsupervised exercise program and Physical fitness and quality of life in people with Elderly and Hypertension, run by Universidade Federal de Goias at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Lower Blood Pressure and or keeping it under control (time frame: 12 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 29 Nov 2016.