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Alternative program of physiotherapy intervention in peripheral arterial disease

Effects of an alternative program of physiotherapy intervention in peripheral arterial disease : a randomised clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN44928994
Enrollment
140
Registered
2011-04-13
Start date
2016-03-01
Completion date
Unknown
Last updated
2019-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral arterial disease with intermittent claudication Circulatory System Other peripheral vascular diseases

Interventions

Current interventions as of 26/10/2015: The volunteers will participate in aerobic training, three times a week for 12 weeks. After selection, the volunteer will be allocated randomly

Sponsors

Federal University of Minas Gerais (UFMG-PRPq) (Brazil)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Adults of both sexes who have ABI 0.4 or who do not have pain at rest

Exclusion criteria

Exclusion criteria: 1. Individuals with ABI > 0.9 2. Presence of diseases or complications that preclude training, such as cardiac failure, unstable angina, arrhythmias, decompensated diabetes (random glucose greater than 250 mg / dl) or signs of haemodynamic instability 3. Patients who have supervised exercise done during the last six months

Design outcomes

Primary

MeasureTime frame
Current primary outcome measures as of 26/10/2015: 1. Initial claudication time (ICT) and absolute claudication time (ACT), initial claudication distance (ICD) and absolute claudication distance (ACD) and resting time required for the symptoms disappear in SWT and constant speed treadmill test 2. Number of plantar flexions performed in the HRT (time in seconds) and velocity (plantar flexions per second) when performing plantar flexions up to the point of volunteer fatigue The results will be measured at time 0 (before intervention) and after 12 weeks of intervention Previous primary outcome measures: Speed and distance walked during the 6WT and SWT The results will be measured at time 0 (before intervention) and after 12 weeks of intervention

Secondary

MeasureTime frame
Current secondary outcome measures as of 26/10/2015: 1. Walking Impairment Questionnaire (WIQ) score in each domain 2. Deoxyhemoglobin (Hb), oxyhemoglobin (HbO2) and oxygen saturation (StO2) in the calf muscles during SWT, HRT and constant speed treadmill test 3. Short Physical Performance Battery (SPPB) score 4. Heart Rate Variability (HRV) during rest and constant speed treadmill test The results will be measured at time 0 (before intervention) and after 12 weeks of intervention Previous secondary outcome measures: 1 Clinical outcomes (time to onset of pain, distance walked by initial pain, duration of maximum pain on SWT and 6WT tests, resting time required for the symptoms disappear) 2. ABI 3. Quality of life (SF-36) The results will be measured at time 0 (before intervention) and after 12 weeks of intervention

Countries

Brazil

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026