Skip to content

A Clinical Trial on the Effects of Home-based Five Plus Exercise Training

A Randomized Clinical Trial on the Effects of Home-based Five Plus Exercise Training

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02310256
Enrollment
30
Registered
2014-12-08
Start date
2014-11-30
Completion date
2016-03-31
Last updated
2018-03-30

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

Conditions

Intermittent Claudication

Keywords

Mitochondria, muscle, Exercise, Blood Flow Velocity

Brief summary

The aim of the study is to evaluate whether walking capacity in patients with intermittent claudication is improved more by home-based 5+ exercise training than by current recommendations of daily walking. The study will elucidate if such a potential effect is dependent on changes in mitochondrial respiratory capacity, blood flow or both.

Interventions

OTHERFive plus exercise training

calf raise exercise

Sponsors

Norwegian University of Science and Technology
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Diagnosed with intermittent claudication secondary to vascular insufficiency * An ankle-brachial index between 0.4 and 0.9.

Exclusion criteria

* Diagnosed with critical limb ischemia * Ankle-brachial index (ABI) \> 0.90 or \< 0.4 * Limited exercise tolerance * Warfarin or heparin usage * Underwent a vascular intervention in the last 6 months * Active cancer, renal- or liver disease

Design outcomes

Primary

MeasureTime frameDescription
absolute walking distance (meters) as measured by 6 minute walking test8 weekstreadmill 3.2 km/hour and inclination increase every 2 minute combined with 6 minute walking test
mitochondrial function measured by respirometry8 weeksOxygen consumption (pmol O2 per second per mg of wet weight tissue) measured by respirometry

Secondary

MeasureTime frameDescription
Arterial bloodflow measured by plethysmography8 weeksmeasured by plethysmography
Quality of life assessed by SF 36 and CLAU-S questionnaires8 weeksassessed by SF 36 and CLAU-S questionnaires
Peak oxygen uptake measured by cardio-pulmonal exercise testing8 weeksmeasured by cardio-pulmonal exercise testing

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026