NCT00118560

Brief Summary

The purposes of this pilot project are to (a) determine changes in calf muscle blood flow and energy supply resulting from calf muscle exercise, and (b) to determine changes in these variables resulting from exercise training (walking and calf muscle exercise). This is a pilot study to prepare for a larger project in the future. Exercise and exercise training should increase blood flow and energy supply to the calf muscles.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Jun 2005

Typical duration for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

June 30, 2005

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 11, 2005

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

March 17, 2011

Status Verified

March 1, 2011

Enrollment Period

2.5 years

First QC Date

June 30, 2005

Last Update Submit

March 16, 2011

Conditions

Diabetes Mellitus, Type 2Intermittent Claudication

Keywords

Collateral CirculationExercise TherapyMicrocirculationOxygenPositron-emission tomographyWalking

Outcome Measures

Primary Outcomes (1)

  • maximal exercise times on treadmill and calf ergometer

    baseline and after 3 months of intervention

Study Arms (1)

1

EXPERIMENTAL

treadmill walking and calf exercise

Behavioral: Physical exerciseBehavioral: Physical walking

Interventions

Physical exerciseBEHAVIORAL

treadmill walking

1
Physical walkingBEHAVIORAL

calf muscle exercise

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Group I (n=25 PAD patients). This sample will represent the population of veterans with PAD with mild mobility impairment secondary to intermittent claudication in the gastrocsoleus muscles.
  • diagnosis of PAD (acute or chronic occlusive arterial disease), with or without diabetes mellitus
  • positive Edinburgh Claudication Questionnaire
  • Fontaine stage IIa only (mild claudication, walking distance \> 200 feet (one-half block)
  • ambulatory, without assistive devices
  • calf muscle claudication within 10 minutes of treadmill walking and calf muscle exercise
  • Group II (n=25 normal control/reference subjects). This reference sample will represent the population of adults without PAD and related problems. They will undergo the PET-exercise testing for perfusion and glucose metabolism measurements, but will not perform the exercise training intervention.
  • healthy adults, matched by age and sex to PAD subjects

You may not qualify if:

  • PAD secondary to Buerger's disease, autoimmune arteritis, fibromuscular dysplasia, chronic and repetitive occupational trauma, venous stasis, hypercoagulability disorder, or arterial embolic disease.
  • inability to perform ankle dorsi and plantar flexion exercise
  • cigarette smoking within last 6 months
  • severe claudication, leg rest pain, skin ulceration, necrosis or gangrene (Fontaine stage \>= IIa)
  • poorly controlled diabetes mellitus (bA1c \>= 9%)
  • poorly controlled hypertension (resting BP \> 140/90 mmHg)
  • Raynaud's syndrome
  • changes in prescribed cardiovascular medications within the past 6 months
  • exertional angina, dyspnea, fatigue, or dizziness
  • severe coronary artery disease
  • congestive heart failure
  • severe COPD
  • exercise intolerance limited by leg pain of nonvascular origin (e.g., arthritis, orthopedic pain)
  • transmetatarsal or more proximal lower-extremity amputation
  • nonambulatory in the last 6 months
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Greater Los Angeles Healthcare System, West LA

West Los Angeles, California, 90073, United States

Location

Related Publications (1)

  • Figoni SF, Kunkel CF, Scremin AM, Scremin OU, Cohen B. Ergometric performance during exercise training in men with intermittent claudication. PM R. 2010 Jun;2(6):528-36. doi: 10.1016/j.pmrj.2010.03.009.

    PMID: 20630439RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Intermittent Claudication

Interventions

Exercise

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPeripheral Arterial DiseasePeripheral Vascular DiseasesVascular DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Stephen F. Figoni

    VA Greater Los Angeles Healthcare System, West LA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

June 30, 2005

First Posted

July 11, 2005

Study Start

June 1, 2005

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

March 17, 2011

Record last verified: 2011-03

Locations

US(1)