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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Brazil1 site
  • Hypertension League

    Goiânia, Goiás, 74000

Other trials in Brazil

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.

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 groups in NCT02976506
Study groupRoleWhat they receive
Unsupervised exercise programExperimentalTo 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 lifeExperimentalTo 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.

  1. Lower Blood Pressure and or keeping it under control

    Measured: 12 weeks

Secondary outcomes (3)
  1. Improve Cardiorespiratory fitness.

    Cooper Test (before and after the intervention).

    Measured: 12 weeks

  2. Improve abdominal strength.

    Abdominal resistance test before and after the intervention.

    Measured: 12 weeks

  3. 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.

  1. First posted29 Nov 2016 (estimated)
  2. Study startMar 2014
  3. Primary completionMar 2016
  4. Study completionMay 2016

Resources

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)
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

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.

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