Low InTensity Exercise Intervention in PAD

NCT02538900 | Completed Results DMC

• 2 other identifiers: STU001058551R01HL122846-01
• Study Type: interventional
• Target: 305
• Locations: 1 country
• Sites: 4

Brief Summary

This proposed study will determine whether a home-based exercise intervention that avoids continuous supervision and exercise-related ischemic pain improves walking performance at 52-week follow-up in people with PAD, compared to an attention control group and compared to a high intensity exercise intervention. In our secondary aims, we will determine whether high intensity exercise improves six-minute walk distance as compared to the attention control group. In secondary aims, we will also determine whether low intensity exercise and high intensity home-based exercise, respectively, improve patient reported outcomes, physical activity, and treadmill walking performance compared to attention control. Our intervention directly addresses two aspects of current practice guidelines that are major barriers to exercise for patients with PAD: 1) the recommendation for supervised exercise and 2) the recommendation for high intensity ischemic-pain inducing walking exercise.

Conditions

Peripheral Artery Disease

Keywords

peripheral arterial disease, peripheral artery disease, PAD, exercise

Outcome Measures

Primary Outcomes (1)

• Six-minute Walk Distance

  In the six-minute walk, participants walk back and forth along a 100-ft hallway for six minutes after standardized instructions to complete as many laps as possible. Distance covered in six minutes is recorded.

  change from baseline to week 52

Secondary Outcomes (7)

• Six-minute Walk Distance

  change from baseline to week 26

• Maximal Treadmill Walking Time

  change from baseline to week 52

• Physical Activity Levels

  Change from baseline to week 52

• Walking Impairment Questionnaire (WIQ) Distance and Speed Score.

  change from baseline to week 52

• Health-related Quality of Life Measure

  change from baseline to week 52

Other Outcomes (5)

• Qualitative Assessment

  At 52 week follow up

• Physical Activity Levels Over Seven Days

  26 week follow-up.

• WIQ Distance and Speed Score

  26 week follow-up

Study Arms (3)

Group 1

EXPERIMENTAL

Low-intensity, self-paced walking exercise. Home based exercise.

Behavioral: Exercise

Group 2

EXPERIMENTAL

Standard high intensity, ischemic pain-inducing walking exercise. Home based exercise.

Behavioral: Exercise

Group 3

ACTIVE COMPARATOR

Non-exercising attention control group. Contact with staff at same frequency as exercise groups, but staff deliver information on health not related to exercise.

Other: Attention control

Interventions

Exercise BEHAVIORAL

Participants in one of the exercise intervention groups will attend once weekly sessions at the medical center for the first four weeks of the study (Weeks 1-4, Phase I). During weeks 5-52 (Phase II), they will receive weekly telephone calls from a study coach.

Group 1; Group 2

Attention control OTHER

Our attention control group controls for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention. Participants randomized to the control group will attend weekly one-hour educational sessions at Northwestern University for the first four weeks of the intervention (Phase I). These sessions are on topics of interest to the typical PAD patient and are led by physicians and other health care workers. Topics include Medicare Part D, nutritional supplements, and cancer screening. During Phase II (weeks 5-52), the attention control group will receive weekly telephone calls, lasting 5-15 minutes, with information on a health-related topic.

Group 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Above or below knee amputation, critical limb ischemia, wheelchair confinement, or foot ulcer.
• Individuals whose walking is limited by a condition other than PAD.
• \> Class II NYHA heart failure or angina. Increase in angina, angina at rest, or abnormal baseline treadmill stress test.
• Major surgery including lower extremity revascularization or orthopedic surgery during the prior three months or anticipated in the next twelve months.
• Major medical illness including renal disease requiring dialysis, lung disease requiring oxygen other than at night, or cancer (other than non-melanoma skin cancer) requiring treatment in the prior three years. Potential participants may still qualify if they have had treatment for early stage cancer in the previous three years and the prognosis is excellent.
• Mini-mental status examination score \<23, dementia, or psychiatric illness including severe depression or anxiety. Investigator discretion may be used to allow some people with an MMSE below 23 to participate if the investigator determines there is another reason for their lower score, including lack of sufficient familiarity with the English language or lack of sufficient education to achieve a score of 23 or higher.
• Currently walking regularly for exercise at a level comparable to the amount of exercise prescribed in the intervention.
• Current or recent (within 3 months) participation in another clinical trial or cardiac rehabilitation. For a clinical trial of a stem cell or gene therapy intervention, potential participants will be potentially eligible immediately after the final study visit for the clinical trial, so long as long as at least six months has passed since the participant received their final treatment in the stem cell or gene therapy intervention. For a clinical trial involving open-label therapy in which the treatment is not related to functional performance and will not change during the LITE Trial, participants may still qualify for the LITE Trial based on investigator discretion.
• Individuals with PAD who have a history of lower extremity revascularization and have a normal ABI.
• Individuals who are not able to walk for exercise at a sufficiently slow pace to avoid ischemic leg symptoms.

Sponsors & Collaborators

• Northwestern University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (4)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Ochsner Baptist, Tulane University

New Orleans, Louisiana, 70121, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (4)

• Whipple MO, Xu S, Zhang D, Guralnik JM, Spring B, Tian L, Treat-Jacobson D, Zhao L, Criqui MH, McDermott MM. Home-Based Exercise and Patient-Reported Outcome Measures in Peripheral Artery Disease: The LITE Randomized Clinical Trial. Am J Cardiol. 2025 Jun 1;244:41-47. doi: 10.1016/j.amjcard.2025.02.027. Epub 2025 Feb 26.

  PMID: 40020770 DERIVED

• Hammond MM, Spring B, Rejeski WJ, Sufit R, Criqui MH, Tian L, Zhao L, Xu S, Kibbe MR, Leeuwenburgh C, Manini T, Forman DE, Treat-Jacobson D, Polonsky TS, Bazzano L, Ferrucci L, Guralnik J, Lloyd-Jones DM, McDermott MM. Effects of Walking Exercise at a Pace With Versus Without Ischemic Leg Symptoms on Functional Performance Measures in People With Lower Extremity Peripheral Artery Disease: The LITE Randomized Clinical Trial. J Am Heart Assoc. 2022 Aug 2;11(15):e025063. doi: 10.1161/JAHA.121.025063. Epub 2022 Jul 27.

  PMID: 35894088 DERIVED

• Slysz JT, Rejeski WJ, Treat-Jacobson D, Bazzano LA, Forman DE, Manini TM, Criqui MH, Tian L, Zhao L, Zhang D, Guralnik JM, Ferrucci L, Kibbe MR, Polonsky TS, Spring B, Sufit R, Leeuwenburgh C, McDermott MM. Sustained physical activity in peripheral artery disease: Associations with disease severity, functional performance, health-related quality of life, and subsequent serious adverse events in the LITE randomized clinical trial. Vasc Med. 2021 Oct;26(5):497-506. doi: 10.1177/1358863X21989430. Epub 2021 Apr 8.

  PMID: 33829920 DERIVED

• McDermott MM, Spring B, Tian L, Treat-Jacobson D, Ferrucci L, Lloyd-Jones D, Zhao L, Polonsky T, Kibbe MR, Bazzano L, Guralnik JM, Forman DE, Rego A, Zhang D, Domanchuk K, Leeuwenburgh C, Sufit R, Smith B, Manini T, Criqui MH, Rejeski WJ. Effect of Low-Intensity vs High-Intensity Home-Based Walking Exercise on Walk Distance in Patients With Peripheral Artery Disease: The LITE Randomized Clinical Trial. JAMA. 2021 Apr 6;325(13):1266-1276. doi: 10.1001/jama.2021.2536.

  PMID: 33821898 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Mary McDermott MD
• Organization: Northwestern University

mdm608@northwestern.edu

312-503-6419

Study Officials

• Mary McDermott, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Individuals collecting the outcome assessment will not be aware of group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: August 31, 2015
• First Posted: September 2, 2015
• Study Start: June 1, 2015
• Primary Completion: October 19, 2020
• Study Completion: October 19, 2020
• Last Updated: November 16, 2021
• Results First Posted: November 16, 2021

Record last verified: 2021-10

Locations

US (4)