Peripheral Artery DiseaseNCT02742220
Isometric Handgrip Training on Blood Pressure of Peripheral Artery Disease Patients
A study testing Isometric Handgrip Training Group in people with Peripheral Artery Disease, run by University of Pernambuco at 1 site in Brazil.
Trial summary
The aim of this study is to analyze the effects of isometric handgrip training (IHT) on blood pressure of hypertensive patients with peripheral arterial disease. Will be recruited 60 patients which will be randomized into 2 groups (30 per group), IHT and control group (CG). Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- Isometric Handgrip Training Group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2016to Dec 2017
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- postmenopausal without hormone therapy replacement, if woman;
- present peripheral artery disease (ankle brachial index < 0.90) in one or both lower limbs;
- do not present neurological / cognitive diseases;
- is able to practice home-based exercise;
Who cannot join
- patients will only be excluded if they make any medication changes before completing the intervention period or present any health problems that prevent physical activity.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Israel Institute of Education and Research Albert Einstein
São Paulo, 05652-900
About this study
Official title: Effects of Isometric Handgrip Training on Blood Pressure Reduction in Patients With Peripheral Artery Disease: A Randomized Clinical Trial
The aim of this study is to analyze the effects of isometric handgrip training (IHT) on blood pressure of hypertensive patients with peripheral arterial disease. Will be recruited 60 patients which will be randomized into 2 groups (30 per group), IHT and control group (CG). IHT group will training isometric contraction for 8 weeks. The GC patients will be encouraged to increase the level of physical activity. In the pre and post-intervention, brachial and central blood pressure will be measured.
Read the detailed description
Meta-analyze studies have shown that IHT promotes reductions in blood pressure (BP), reaching 10 mmHg for systolic and diastolic 7 mmHg. However, remain uncertain the effects of this type of training on BP in patients with more severe cardiovascular diseases such as peripheral artery disease. Because this type of training which requires approximately 20 minutes per session and does not require supervision, it is possible that this intervention is interesting to reduce BP of these patients. The aim of this study is to analyze the effects of IHT on blood pressure of hypertensive patients with peripheral arterial disease. Will be recruited 60 patients, which will be randomized into 2 groups (30 per group), IHT and control group (CG). IHT group will hold three sessions per week with four unilateral sets with two minutes of isometric contraction at 30% of maximal voluntary contraction and interval of four minutes between them, for 8 weeks. The GC patients will be encouraged to increase the level of physical activity. In the pre and post-intervention, is going to be evaluated functional capacity, brachial and central BP, arterial stiffness, cardiovascular autonomic modulation and muscle vasodilation. Will be used to analyze two-factor variance for repeated measures, with group (IHT and GC) and the time (before and after 8 weeks) as factors and the post-hoc test of Newman-Keuls.
- Conditions
- Peripheral Artery Disease
- Being tested
- Isometric Handgrip Training Group, Control Group
- Keywords
- intermittent claudication, exercise, blood pressure, cardiovascular system
- Medical subject headings
- Peripheral Arterial Disease, Intermittent Claudication, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isometric Handgrip Training GroupOther
Also called Isometric resistance exercise
Intervention period will last eight weeks. Experimental group will perform three sessions per week of home-based handgrip exercise. The exercise protocol will consist of four unilateral sets (dominant arm) with two minutes of isometric contraction, with 30% of maximum voluntary contraction, and four minutes of interval between sets. Patients will receive a diary to record the sessions and report difficulties during the training. Visits will be scheduled at weeks 1 and 5 to provide feedback to individuals, discuss possible problems during the training and adjust the intensity of the exercise. In addition the patients be recommended to increase daily physical activity levels, and weekly, there will be phone contacts with the patients to reinforce the exercise recommendations.
Control GroupOther
Intervention period will last eight weeks. Patients will be recommended to increase daily physical activity levels, and weekly, there will be phone contacts to reinforce the recommendations.
| Study group | Role | What they receive |
|---|---|---|
| Isometric Handgrip Training Group | Experimental | Experimental group will perform home-based unilateral handgrip exercise and will be recommended to increase daily physical activity levels. Receives: Other: Isometric Handgrip Training Group |
| Control Group | Sham comparator | Control group will be recommended to increase daily physical activity levels. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in blood pressure at eight weeks
Blood pressure will be measured before and after eight weeks of intervention period on intervention and control group by an automatic blood pressure monitor (HEM-742, Omron Healthcare, Japan).
Measured: Baseline and eight weeks
Secondary outcomes (3)
Change from baseline in autonomic cardiac modulation at eight weeks
Cardiac autonomic modulation will be measured before and after eight weeks of intervention period on intervention and control group by heart rate monitor (Polar, RS 800, USA).
Measured: Baseline and eight weeks
Change from baseline in vasodilatory capacity at eight weeks
Vasodilatory capacity will be measured before and after eight weeks of intervention period on intervention and control group by a flow mediated dilation measurement with an ultrasound image (HDI 5000 Sono CT, Philips, The Netherlands).
Measured: Baseline and eight weeks
Change from baseline in arterial stiffness at eight weeks
Arterial stiffness will be measured before and after eight weeks of intervention period on intervention and control group by pulse wave velocity measurement with applanation tonometry (SphygmoCor, AtCor Medical, Australia).
Measured: Baseline and eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2017
- Study completionDec 2017
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 Peripheral Artery DiseaseStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pernambuco
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Raphael M. Ritti Dias, University of Pernambuco
- Investigators
- Raphael Ritti-Dias, PhD, Principal investigator, Israel Institute of Education and Research Albert EinsteinGabriel Cucato, PhD, Study director, Israel Institute of Education and Research Albert Einstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02742220
- Sponsor's protocol ID
- IHT PAD
- Status last verified
- Feb 2018
- First submitted
- 4 Apr 2016
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: The IPD data to be shared are the indivividual and mean data of blood pressure responses to eight weeks of isometric handgrip training.
Publications
A Correia M, Oliveira PL, Farah BQ, Vianna LC, Wolosker N, Puech-Leao P, Green DJ, Cucato GG, Ritti-Dias RM. Effects of Isometric Handgrip Training in Patients With Peripheral Artery Disease: A Randomized Controlled Trial. J Am Heart Assoc. 2020 Feb 18;9(4):e013596. doi: 10.1161/JAHA.119.013596. Epub 2020 Feb 6.
PubMed 32067595
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Isometric Handgrip Training on Blood Pressure Reduction in Patients With Peripheral Artery Disease: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02742220
- Acronym / sponsor ID
- IHT PAD
- Conditions
- Peripheral Artery Disease
- Keywords
- intermittent claudication, exercise, blood pressure, cardiovascular system
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University of PernambucoUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Mar 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 18 Apr 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.
The aim of this study is to analyze the effects of isometric handgrip training (IHT) on blood pressure of hypertensive patients with peripheral arterial disease. Will be recruited 60 patients which will be randomized into 2 groups (30 per group), IHT and control group (CG). IHT group will training isometric contraction for 8 weeks. The GC patients will be encouraged to increase the level of physical activity. In the pre and post-intervention, brachial and central blood pressure will be measured.
Detailed description
Meta-analyze studies have shown that IHT promotes reductions in blood pressure (BP), reaching 10 mmHg for systolic and diastolic 7 mmHg. However, remain uncertain the effects of this type of training on BP in patients with more severe cardiovascular diseases such as peripheral artery disease. Because this type of training which requires approximately 20 minutes per session and does not require supervision, it is possible that this intervention is interesting to reduce BP of these patients. The aim of this study is to analyze the effects of IHT on blood pressure of hypertensive patients with peripheral arterial disease. Will be recruited 60 patients, which will be randomized into 2 groups (30 per group), IHT and control group (CG). IHT group will hold three sessions per week with four unilateral sets with two minutes of isometric contraction at 30% of maximal voluntary contraction and interval of four minutes between them, for 8 weeks. The GC patients will be encouraged to increase the level of physical activity. In the pre and post-intervention, is going to be evaluated functional capacity, brachial and central BP, arterial stiffness, cardiovascular autonomic modulation and muscle vasodilation. Will be used to analyze two-factor variance for repeated measures, with group (IHT and GC) and the time (before and after 8 weeks) as factors and the post-hoc test of Newman-Keuls.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isometric Handgrip Training Group | Experimental | Other: Isometric Handgrip Training GroupExperimental group will perform home-based unilateral handgrip exercise and will be recommended to increase daily physical activity levels. |
| Control Group | Sham comparator | Other: Control GroupControl group will be recommended to increase daily physical activity levels. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- postmenopausal without hormone therapy replacement, if woman;
- present peripheral artery disease (ankle brachial index < 0.90) in one or both lower limbs;
- do not present neurological / cognitive diseases;
- is able to practice home-based exercise;
Key exclusion criteria (1 listed)
- patients will only be excluded if they make any medication changes before completing the intervention period or present any health problems that prevent physical activity.
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 |
|---|---|---|
| Isometric Handgrip Training GroupAlso: Isometric resistance exerciseIntervention period will last eight weeks. Experimental group will perform three sessions per week of home-based handgrip exercise. The exercise protocol will consist of four unilateral sets (dominant arm) with two minutes of isometric contraction, with 30% of maximum voluntary contraction, and four minutes of interval between sets. Patients will receive a diary to record the sessions and report difficulties during the training. Visits will be scheduled at weeks 1 and 5 to provide feedback to individuals, discuss possible problems during the training and adjust the intensity of the exercise. In addition the patients be recommended to increase daily physical activity levels, and weekly, there will be phone contacts with the patients to reinforce the exercise recommendations. | Other | Isometric Handgrip Training Group |
| Control GroupIntervention period will last eight weeks. Patients will be recommended to increase daily physical activity levels, and weekly, there will be phone contacts to reinforce the recommendations. | Other | Control Group |
Primary outcome
Change from baseline in blood pressure at eight weeks
Time frame: Baseline and eight weeks
Blood pressure will be measured before and after eight weeks of intervention period on intervention and control group by an automatic blood pressure monitor (HEM-742, Omron Healthcare, Japan).
3 secondary outcomes
Change from baseline in autonomic cardiac modulation at eight weeks
Time frame: Baseline and eight weeks
Change from baseline in vasodilatory capacity at eight weeks
Time frame: Baseline and eight weeks
Change from baseline in arterial stiffness at eight weeks
Time frame: Baseline and eight 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 5 Feb 2018.
- Derived from this study: PubMed 32067595A Correia M, Oliveira PL, Farah BQ, Vianna LC, Wolosker N, Puech-Leao P, Green DJ, Cucato GG, Ritti-Dias RM. Effects of Isometric Handgrip Training in Patients With Peripheral Artery Disease: A Randomized Controlled Trial. J Am Heart Assoc. 2020 Feb 18;9(4):e013596. doi: 10.1161/JAHA.119.013596. Epub 2020 Feb 6.
- Individual participant dataSharing planned: Undecided. The IPD data to be shared are the indivividual and mean data of blood pressure responses to eight weeks of isometric handgrip training.
Related trials for Peripheral Artery Disease
Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
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.
Raphael Ritti-Dias, PhD principal investigator
Israel Institute of Education and Research Albert Einstein
Gabriel Cucato, PhD study director
Israel Institute of Education and Research Albert Einstein
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isometric Handgrip Training Group in people with Peripheral Artery Disease, run by University of Pernambuco 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 4 inclusion and 1 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 5 Feb 2018. 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?
Change from baseline in blood pressure at eight weeks (time frame: Baseline and eight weeks). 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 NCT02742220, 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 5 Feb 2018.