Arthritis, RheumatoidSRANCT01919645
Effectiveness and Safety of Physical Exercises in the Improvement of the Sleep Quality. Regarding Rheumatoid Arthritis
A study testing Combined Training ( Strength + Aerobics) in people with Arthritis, Rheumatoid, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
Physical exercise programs are effective and safe for the improvement of the sleep efficiency in patients with Rheumatoid Arthritis. Read more about this study
- Who is it for?
- Ages 35 to 65 years, women only
- Conditions the study is for
- Arthritis, Rheumatoid
- What is being tested?
- Combined Training ( Strength + Aerobics)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2012to Dec 2013
- 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 35 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women ages 35-65 years diagnosed with Rheumatoid Arthritis according with the American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR)Criteria; Pittsburgh Sleep Quality Index ≥ 5; electrocardiogram test (ECG) at rest and at regular effort.
Who cannot join
- Patients with joint restrictions due to disease.
- Other rheumatoid-associated diseases (Fibromyalgia) with the exception of Osteoarthritis of low degree.
- Those who are uncontrollably hypertense, diabetic, with thyroidopathy and cardiorespiratory diseases which stop them from practicing exercises.
- Class II obesity (IMC ≥ 35 Kg/m2).
- Cognitive deficits.
- Depression.
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- Patients not following the study rules such as exercise hours and / or time for the proposed program.
- Current physical exercise practitioner.
- Those undergoing medication treatment which would interfere sleep.
- Night shift workers who disrespect regular working schedule.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Centro de Estudos em Psicobiologia e Exercício (CEPE) da Associação Fundo de Incentivo a Pesquisa (AFIP)
São Paulo, São Paulo, 04026-001
About this study
Official title: Effectiveness and Safety of Physical Exercises in the Improvement of the Sleep Quality in Women With Rheumatoid Arthritis: A Randomized Clinical Trial Study
Physical exercise programs are effective and safe for the improvement of the sleep efficiency in patients with Rheumatoid Arthritis.
- Conditions
- Arthritis, Rheumatoid
- Being tested
- Combined Training ( Strength + Aerobics)
- Keywords
- Rheumatoid Arthritis, Sleep Disorders, Polysomnography, Sleep Stages, Physical Exercise
- Medical subject headings
- Arthritis, Rheumatoid, Sleep Wake Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Training ( Strength + Aerobics)Other
Strength training performed using workout devices and aerobic training performed using stationary bicycle.
| Study group | Role | What they receive |
|---|---|---|
| Combined Training Group | Experimental | Combined Training - (strength + aerobics).
A combined training (CT)is performed, having aerobics exercises (AE)using a stationary bicycle and strength training in workout devices.
The strength training (ST) will be performed by isotonic exercises recruiting the main muscle groups. They exercises are: Chest Press, Leg Press, Vertical Traction, Leg Extension and Abdominal Crunch. Receives: Other: Combined Training ( Strength + Aerobics) |
| Control Group | Placebo comparator | The control group patients did not perform any intervention through physical exercises. They were oriented on Sleep Hygiene and were followed during the study. They were asked to come to the following visits (at weeks 8 and 16) and to 2 additional visits to get and then return the actigraph. During this period, they were followed through phone calls once a month and were asked for sleep hygiene and were reminded of their assessment dates. Receives: Other: Combined Training ( Strength + Aerobics) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of sleep through a polysomnogram exam.
Evaluation of N3 stage of the sleep through a polysomnogram before and after 16 weeks of supervised exercises.
Measured: at baseline and at end-week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2013 (estimated)
- Study startJul 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, RheumatoidStudies 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
- Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Kayo, Federal University of São Paulo
- Investigators
- Andrea H Kayo, PHD student, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01919645
- Sponsor's protocol ID
- AHK2013
- Acronym
- SRA
- Status last verified
- Aug 2016
- First submitted
- 3 Aug 2013
- Last updated
- 2 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Physical Exercises in the Improvement of the Sleep Quality in Women With Rheumatoid Arthritis: A Randomized Clinical Trial Study
- ClinicalTrials.gov ID
- NCT01919645
- Acronym / sponsor ID
- SRA / AHK2013
- Conditions
- Arthritis, Rheumatoid
- Keywords
- Rheumatoid Arthritis, Sleep Disorders, Polysomnography, Sleep Stages, Physical Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 9 Aug 2013 (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.
Physical exercise programs are effective and safe for the improvement of the sleep efficiency in patients with Rheumatoid Arthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined Training Group | Experimental | Other: Combined Training ( Strength + Aerobics)Combined Training - (strength + aerobics). A combined training (CT)is performed, having aerobics exercises (AE)using a stationary bicycle and strength training in workout devices. The strength training (ST) will be performed by isotonic exercises recruiting the main muscle groups. They exercises are: Chest Press, Leg Press, Vertical Traction, Leg Extension and Abdominal Crunch. |
| Control Group | Placebo comparator | Other: Combined Training ( Strength + Aerobics)The control group patients did not perform any intervention through physical exercises. They were oriented on Sleep Hygiene and were followed during the study. They were asked to come to the following visits (at weeks 8 and 16) and to 2 additional visits to get and then return the actigraph. During this period, they were followed through phone calls once a month and were asked for sleep hygiene and were reminded of their assessment dates. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women ages 35-65 years diagnosed with Rheumatoid Arthritis according with the American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR)Criteria; Pittsburgh Sleep Quality Index ≥ 5; electrocardiogram test (ECG) at rest and at regular effort.
Key exclusion criteria (10 listed)
- Patients with joint restrictions due to disease.
- Other rheumatoid-associated diseases (Fibromyalgia) with the exception of Osteoarthritis of low degree.
- Those who are uncontrollably hypertense, diabetic, with thyroidopathy and cardiorespiratory diseases which stop them from practicing exercises.
- Class II obesity (IMC ≥ 35 Kg/m2).
- Cognitive deficits.
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 |
|---|---|---|
| Combined Training ( Strength + Aerobics)Strength training performed using workout devices and aerobic training performed using stationary bicycle. | Other | Combined Training Group, Control Group |
Primary outcome
Improvement of sleep through a polysomnogram exam.
Time frame: at baseline and at end-week 16
Evaluation of N3 stage of the sleep through a polysomnogram before and after 16 weeks of supervised exercises.
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 2 Sep 2016.
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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.
Andrea H Kayo, PHD student principal investigator
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined Training ( Strength + Aerobics) in people with Arthritis, Rheumatoid, run by Federal University of São Paulo 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?
The sponsor lists 1 inclusion and 10 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 2 Sep 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. Some participants in this study may receive a placebo. 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?
Improvement of sleep through a polysomnogram exam. (time frame: at baseline and at end-week 16). 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 2 Sep 2016.