Peripheral Arterial DiseasePhase 3NCT00879697
Strength Training in Walking Tolerance in Intermittent Claudication Patients
A Phase 3 study testing Walking Training and Strength Training in people with Peripheral Arterial Disease and Hypertension, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Background: Muscle atrophy and reduced leg strength are related to exercise intolerance in patients with intermittent claudication (IC), suggesting that strength training (ST) could improve exercise performance in these patients. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Peripheral Arterial Disease, Hypertension, Diabetes
- What is being tested?
- Walking Training and Strength Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2005to Dec 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fontaine stage II peripheral arterial disease(14)
- Symptoms of intermittent claudication for at least 6 months
- Ankle/brachial index (ABI) at rest ≤ 0.90 in 1 or 2 legs
- Reduction of ABI after treadmill test
- Exercise tolerance limited by intermittent claudication
Who cannot join
- Presence of chronic lung disease
- Inability to obtain ABI measurement due to noncompressible vessels
- Exercise tolerance limited by factors other than claudication (e.g., dyspnea or orthopedic problems)
- Poorly controlled blood pressure
- Presence of electrocardiogram response suggestive of myocardial ischemia during the exercise test
- History of revascularization in the previous year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Strength Training and Walking Training on Physical Fitness of Patients With Intermittent Claudication
Background: Muscle atrophy and reduced leg strength are related to exercise intolerance in patients with intermittent claudication (IC), suggesting that strength training (ST) could improve exercise performance in these patients.
Objective: Analyze the effects of ST in walking capacity in patients with IC comparing with walking training (WT) effects.
Read more
Intervention: Patients were randomized into ST and WT. Both groups trained twice a week, for 12 weeks, at the same rate of perceived exertion. ST consisted of 3 sets of 10 repetitions of whole body exercises. WT consisted of 15 two-minute bouts of walking intercalated with 2 minutes of resting.
Measurements: Walking capacity, peak VO2, walking economy, ankle brachial index, ischemic window and knee extension strength
Read the detailed description
From July 2005 to December 2006, three hundred patients with peripheral arterial disease, who were enrolled in a tertiary center specialized in vascular disease and were able to walk for at least 2 minutes at 2 miles per hour, were invited to a meeting at which explanations about this study were given. 80 patients attended the meeting, 60 of them decided to take part of the study, and 52 attended for the screening tests.
Patients were included in the study if they met the following criteria: Fontaine stage II peripheral arterial disease, symptoms of IC for at least 6 months, ankle/brachial index (ABI) at rest ≤ 0.90 in 1 or 2 legs, reduction of ABI after treadmill test, and exercise tolerance limited by IC. Patients were excluded under the following conditions: presence of chronic lung disease, inability to obtain ABI measurement due to noncompressible vessels, exercise tolerance limited by factors other than claudication (eg, dyspnea or orthopedic problems), poorly controlled blood pressure, presence of electrocardiogram response suggestive of myocardial ischemia during the exercise test, and history of revascularization in the previous year.
Procedures Patients were randomly (by drawing lots) divided into 2 groups: strength (ST, n = 17) and walking (WT, n = 17) training. They were evaluated at baseline (pre-training) and after 12 weeks of exercise training (post-training). During evaluations were assessed exercise tolerance and strength.
Both training programs (ST and WT) were supervised, conducted twice a week, lasted for 12 weeks, and started after a 2-week preconditioning-orientation phase. In both programs, rate of perceived exertion during exercise was kept similar and between 11 to 13 on the15-grade Borg scale. Furthermore, the duration of exercise sessions was prescribed as 30 min of exercise for ST and WT groups.
- Conditions
- Peripheral Arterial Disease, Hypertension, Diabetes
- Being tested
- Walking Training, Strength Training
- Keywords
- peripheral arterial disease, exercise, resistance training, cardiac rehabilitation
- Medical subject headings
- Peripheral Arterial Disease, Hypertension, Diabetes Mellitus, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walking TrainingBehavioural
Also called Walk training, Walk exercise
The Walking Training program was performed using a treadmill. In each session, patients performed fifteen 2-min bouts of exercise followed by a 2-min rest interval, as previously described. Walking speed was set in order to induce perceived exertion of 11 to 13 and claudication pain in the last 30 seconds of each exercise bout.
Strength TrainingBehavioural
Also called Resistance training, Weight training
The strength training program consisted of 8 exercises (leg press, crunches, unilateral knee extension, seated row, unilateral knee flexion, seated bench press, calf raises on leg press, and seated back extension). In each exercise, subjects performed 3 sets of 10 repetitions with a 2-min interval between sets and exercises.
| Study group | Role | What they receive |
|---|---|---|
| Strength training | Active comparator | Patients who performed strength training. The strength training program was composed by 8 exercises for whole body performed at sub-maximal intensity prescribed according to the patients self-perceived effort Receives: Behavioral: Strength Training |
| Walking training | Active comparator | Patients who performed walking training. The walking training was performed in a treadmill using sub-maximal intensity prescribed based in patients self perceived effort Receives: Behavioral: Walking Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Walking Distance
The maximal walking distance
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 posted10 Apr 2009 (estimated)
- Study startJul 2005
- Primary completionAug 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Raphael Mendes Ritti Dias, University of Sao Paulo
- Investigators
- Maria FN Marucci, PhD, Study chair, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00879697
- Sponsor's protocol ID
- 44444
- Status last verified
- Oct 2016
- First submitted
- 27 Jan 2009
- Last updated
- 15 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Dias RM, Forjaz CL, Cucato GG, Costa LA, Camara LC, Wolosker N, Marucci Mde F. Obesity decreases time to claudication and delays post-exercise hemodynamic recovery in elderly peripheral arterial disease patients. Gerontology. 2009;55(1):21-6. doi: 10.1159/000155219. Epub 2008 Sep 11.
PubMed 18784409Grizzo Cucato G, de Moraes Forjaz CL, Kanegusuku H, da Rocha Chehuen M, Riani Costa LA, Wolosker N, Kalil Filho R, de Fatima Nunes Marucci M, Mendes Ritti-Dias R. Effects of walking and strength training on resting and exercise cardiovascular responses in patients with intermittent claudication. Vasa. 2011 Sep;40(5):390-7. doi: 10.1024/0301-1526/a000136.
PubMed 21948782Ritti-Dias RM, Wolosker N, de Moraes Forjaz CL, Carvalho CR, Cucato GG, Leao PP, de Fatima Nunes Marucci M. Strength training increases walking tolerance in intermittent claudication patients: randomized trial. J Vasc Surg. 2010 Jan;51(1):89-95. doi: 10.1016/j.jvs.2009.07.118. Epub 2009 Oct 17.
PubMed 19837534
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Strength Training and Walking Training on Physical Fitness of Patients With Intermittent Claudication
- ClinicalTrials.gov ID
- NCT00879697
- Acronym / sponsor ID
- 44444
- Conditions
- Peripheral Arterial Disease, Hypertension, Diabetes
- Keywords
- peripheral arterial disease, exercise, resistance training, cardiac rehabilitation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Jul 2005
- Primary completion
- Aug 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 10 Apr 2009 (estimated)
- Results
- Posted 10 Apr 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Muscle atrophy and reduced leg strength are related to exercise intolerance in patients with intermittent claudication (IC), suggesting that strength training (ST) could improve exercise performance in these patients.
Objective: Analyze the effects of ST in walking capacity in patients with IC comparing with walking training (WT) effects.
Intervention: Patients were randomized into ST and WT. Both groups trained twice a week, for 12 weeks, at the same rate of perceived exertion. ST consisted of 3 sets of 10 repetitions of whole body exercises. WT consisted of 15 two-minute bouts of walking intercalated with 2 minutes of resting.
Measurements: Walking capacity, peak VO2, walking economy, ankle brachial index, ischemic window and knee extension strength
Detailed description
From July 2005 to December 2006, three hundred patients with peripheral arterial disease, who were enrolled in a tertiary center specialized in vascular disease and were able to walk for at least 2 minutes at 2 miles per hour, were invited to a meeting at which explanations about this study were given. 80 patients attended the meeting, 60 of them decided to take part of the study, and 52 attended for the screening tests.
Patients were included in the study if they met the following criteria: Fontaine stage II peripheral arterial disease, symptoms of IC for at least 6 months, ankle/brachial index (ABI) at rest ≤ 0.90 in 1 or 2 legs, reduction of ABI after treadmill test, and exercise tolerance limited by IC. Patients were excluded under the following conditions: presence of chronic lung disease, inability to obtain ABI measurement due to noncompressible vessels, exercise tolerance limited by factors other than claudication (eg, dyspnea or orthopedic problems), poorly controlled blood pressure, presence of electrocardiogram response suggestive of myocardial ischemia during the exercise test, and history of revascularization in the previous year.
Procedures Patients were randomly (by drawing lots) divided into 2 groups: strength (ST, n = 17) and walking (WT, n = 17) training. They were evaluated at baseline (pre-training) and after 12 weeks of exercise training (post-training). During evaluations were assessed exercise tolerance and strength.
Both training programs (ST and WT) were supervised, conducted twice a week, lasted for 12 weeks, and started after a 2-week preconditioning-orientation phase. In both programs, rate of perceived exertion during exercise was kept similar and between 11 to 13 on the15-grade Borg scale. Furthermore, the duration of exercise sessions was prescribed as 30 min of exercise for ST and WT groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strength training | Active comparator | Behavioral: Strength TrainingPatients who performed strength training. The strength training program was composed by 8 exercises for whole body performed at sub-maximal intensity prescribed according to the patients self-perceived effort |
| Walking training | Active comparator | Behavioral: Walking TrainingPatients who performed walking training. The walking training was performed in a treadmill using sub-maximal intensity prescribed based in patients self perceived effort |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Fontaine stage II peripheral arterial disease(14)
- Symptoms of intermittent claudication for at least 6 months
- Ankle/brachial index (ABI) at rest ≤ 0.90 in 1 or 2 legs
- Reduction of ABI after treadmill test
- Exercise tolerance limited by intermittent claudication
Key exclusion criteria (6 listed)
- Presence of chronic lung disease
- Inability to obtain ABI measurement due to noncompressible vessels
- Exercise tolerance limited by factors other than claudication (e.g., dyspnea or orthopedic problems)
- Poorly controlled blood pressure
- Presence of electrocardiogram response suggestive of myocardial ischemia during the exercise test
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 |
|---|---|---|
| Walking TrainingAlso: Walk training, Walk exerciseThe Walking Training program was performed using a treadmill. In each session, patients performed fifteen 2-min bouts of exercise followed by a 2-min rest interval, as previously described. Walking speed was set in order to induce perceived exertion of 11 to 13 and claudication pain in the last 30 seconds of each exercise bout. | Behavioural | Walking training |
| Strength TrainingAlso: Resistance training, Weight trainingThe strength training program consisted of 8 exercises (leg press, crunches, unilateral knee extension, seated row, unilateral knee flexion, seated bench press, calf raises on leg press, and seated back extension). In each exercise, subjects performed 3 sets of 10 repetitions with a 2-min interval between sets and exercises. | Behavioural | Strength training |
Primary outcome
Total Walking Distance
Time frame: 12 weeks
The maximal walking distance
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 18784409Dias RM, Forjaz CL, Cucato GG, Costa LA, Camara LC, Wolosker N, Marucci Mde F. Obesity decreases time to claudication and delays post-exercise hemodynamic recovery in elderly peripheral arterial disease patients. Gerontology. 2009;55(1):21-6. doi: 10.1159/000155219. Epub 2008 Sep 11.
- Derived from this study: PubMed 21948782Grizzo Cucato G, de Moraes Forjaz CL, Kanegusuku H, da Rocha Chehuen M, Riani Costa LA, Wolosker N, Kalil Filho R, de Fatima Nunes Marucci M, Mendes Ritti-Dias R. Effects of walking and strength training on resting and exercise cardiovascular responses in patients with intermittent claudication. Vasa. 2011 Sep;40(5):390-7. doi: 10.1024/0301-1526/a000136.
- Derived from this study: PubMed 19837534Ritti-Dias RM, Wolosker N, de Moraes Forjaz CL, Carvalho CR, Cucato GG, Leao PP, de Fatima Nunes Marucci M. Strength training increases walking tolerance in intermittent claudication patients: randomized trial. J Vasc Surg. 2010 Jan;51(1):89-95. doi: 10.1016/j.jvs.2009.07.118. Epub 2009 Oct 17.
- Individual participant dataSharing planned: No
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Peripheral Arterial Disease
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.
Maria FN Marucci, PhD study chair
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Walking Training and Strength Training in people with Peripheral Arterial Disease and Hypertension, run by University of Sao 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 5 inclusion and 6 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 15 Dec 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Apr 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Total Walking Distance (time frame: 12 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 NCT00879697, which also lists 3 linked publications.
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 15 Dec 2016.