The TELEX trial will establish whether telmisartan alone improves walking performance in people with peripheral artery disease (PAD). The TELEX trial will also determine whether telmisartan plus supervised exercise improves walking performance more than either therapy alone. TELEX is a randomized controlled clinical trial (2 x 2 factorial design) of 112 participants with PAD randomized to one of four arms: Group A: telmisartan + supervised exercise therapy; Group B: telmisartan + a "no exercise" control group; Group C: placebo + supervised exercise therapy; and Group D: placebo + a "no exercise" control group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
114
Participants randomized to the exercise intervention will receive supervised treadmill exercise three times weekly for six months.
Participants randomized to the telmisartan arm of the study will take 20 mg or 40 mg of telmisartan daily based on the results of their study run-in. Participants will have their dose increased to up to 80 mg as tolerated.
Participants randomized to the attention control group will attend weekly one-hour educational sessions at Northwestern University for six months.
Northwestern University
Chicago, Illinois, United States
Tulane University
New Orleans, Louisiana, United States
Ochsner Medical Center
New Orleans, Louisiana, United States
Six-minute Walk Performance
We will determine whether telmisartan therapy with or without exercise improves six-minute walk distance at 6-month follow-up, compared to placebo with or without exercise (i.e. two group comparisons of all participants randomized to telmisartan vs. all participants randomized to placebo).
Time frame: Change from baseline to six-month follow-up
Maximal Treadmill Walking Distance
In the treadmill walking test, participants walk on either a gardner or modified gardner protocol until they stop the test. Distance walked is recorded.
Time frame: Change from baseline to six-month follow-up
Walking Impairment Questionnaire (WIQ) Distance Score
The WIQ is a well validated questionnaire that measures patient-reported walking limitations in distance and speed and stair-climbing. They are scored on a 0-100 scale and that 100 indicates the best possible score.
Time frame: Change from baseline to six-month follow-up
SF-36 Physical Functioning Score
The SF-36 physical functioning score will be used to measure quality of life. They are scored on a 0-100 scale and that 100 indicates the best possible score.
Time frame: Change from baseline to six-month follow-up
Walking Impairment Questionnaire (WIQ) Speed Score
The WIQ is a well validated questionnaire that measures patient-reported walking limitations in distance and speed and stair-climbing. They are scored on a 0-100 scale and that 100 indicates the best possible score.
Time frame: Change from baseline to six-month follow-up
Walking Impairment Questionnaire (WIQ) Stair-climbing Score
The WIQ is a well validated questionnaire that measures patient-reported walking limitations in distance and speed and stair-climbing. They are scored on a 0-100 scale and that 100 indicates the best possible score.
Time frame: Change from baseline to six-month follow-up
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