Contact information
Type
Scientific
Primary contact
Dr Susan Rebecca Kahn
ORCID ID
Contact details
Sir Mortimer B. Davis Jewish General Hospital
3755 Cote Ste. Catherine
rm A-127
Montreal
Quebec
H3T 1E2
Canada
+1 514 340 8222 ext. 4667
susan.kahn@mcgill.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MCT-82338
Study information
Scientific title
Exercise training for the treatment of post-thrombotic syndrome: a multicentre, two-arm randomised controlled parallel trial
Acronym
EXPO
Study hypothesis
In our proposed pilot trial, we will randomise patients with post-thrombotic syndrome (PTS) to:
1. A six-month exercise training program designed to improve leg strength, leg endurance, leg flexibility and general cardiovascular fitness (Active Training), or
2. An Attention Control group
Our feasibility objectives are to assess levels of patient eligibility, consent, adherence and retention. Our scientific objectives are to obtain estimates of effect size associated with Active Training, by describing within-subject change over six months in quality of life (QOL), severity of PTS, calf strength, calf flexibility and exercise capacity (time-on-treadmill) in the Active Training and Attention Control groups. Our results will inform the design of a large, multicentre trial of exercise training to treat PTS.
Ethics approval
Research Ethics Committee of the Sir Mortimer B. Davis Jewish General Hospital (Canada) approved on the 13th October 2006 (ref: 06-080).
Study design
Multicentre, two-arm randomised parallel trial with outcome assessor and data analyst blinding
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Post-thrombotic syndrome
Intervention
Active Training:
Six-month exercise training program designed to improve leg strength, leg endurance, leg flexibility and general cardiovascular fitness.
Attention Control:
Six-month program consisting of:
1. Standardised one-hour education session on PTS (what PTS is, why patients get it, how to manage it; exercise will be kept 'neutral', i.e., not specifically addressed) given by a trained thrombosis nurse-educator not involved with the assessment of study outcomes, and
2. Monthly phone contacts by the same thrombosis nurse to 'check in' with the patient, ask about their PTS and provide support
Contact for public queries:
Adrielle H. Houweling
Clinical Trial Coordinator, The EXPO Pilot Trial
Sir Mortimer B. Davis Jewish General Hospital
3755 Cote St. Catherine, rm. A-121
Montreal, Quebec
H3T 1E2
Canada
Tel: +1 514 340 8222 ext. 4717
Fax: +1 514 340 7564
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Feasibility indicators (measured throughout trial):
1. Proportion of patients screened who are eligible to participate in the trial
2. Proportion of eligible patients who consent to participate in the trial
3. Proportion of subjects who are adherent with the intervention
4. Proportion of subjects who complete the trial
Secondary outcome measures
1. Venous disease-specific, measured at baseline, 3 months and 6 months
2. Generic QOL, measured at baseline, 3 months and 6 months
3. Severity of PTS (Villalta PTS Scale), measured at baseline, 3 months and 6 months
4. Leg (triceps surae) strength, measured at baseline, 3 months and 6 months
5. Leg flexibility, measured at baseline, 3 months and 6 months
6. Time-on-treadmill, measured at pre-randomisation and 6 months
Overall trial start date
01/03/2006
Overall trial end date
30/09/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged 18 - 75 years, either sex
2. Previous unilateral deep vein thrombosis (DVT) diagnosed using standardised ultrasound or venographic criteria
3. PTS in same leg as previous DVT (Villalta PTS Scale score greater than 4)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
44
Participant exclusion criteria
1. Acute DVT within previous six months
2. Contra-indications to exercise training, e.g. arthritis of lower extremities, angina, symptomatic chronic obstructive lung disease, congestive heart failure, severe claudication, poor balance
3. Expected lifespan less than six months or general medical condition that would make study unfeasible, e.g. advanced cancer or cardiopulmonary disease
4. Pregnancy or lactation
5. Open venous leg ulcer
6. Not conversant in either English or French
7. Geographic inaccessibility which precludes participation
8. Unwilling or unable to provide signed informed consent
9. Screening (i.e. pre-randomisation) exercise stress test (Bruce Ramp protocol) demonstrating uncontrolled hypertension, ischaemia, or arrhythmia (such patients will be referred for appropriate medical evaluation)
Recruitment start date
01/03/2006
Recruitment end date
30/09/2008
Locations
Countries of recruitment
Canada
Trial participating centre
Sir Mortimer B. Davis Jewish General Hospital
Montreal, Quebec
H3T 1E2
Canada
Sponsor information
Organisation
Sir Mortimer B. Davis Jewish General Hospital (Hôpital Général Juif Sir Mortimer B. Davis) (Canada)
Sponsor details
3755 Côte Ste-Catherine Road
Montreal
Quebec
H3T 1E2
Canada
+1 514 340 8222 ext. 5252
razoulay@jgh.mcgill.ca
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-82338)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21098066
Publication citations
-
Results
Kahn SR, Shrier I, Shapiro S, Houweling AH, Hirsch AM, Reid RD, Kearon C, Rabhi K, Rodger MA, Kovacs MJ, Anderson DR, Wells PS, Six-month exercise training program to treat post-thrombotic syndrome: a randomized controlled two-centre trial., CMAJ, 2011, 183, 1, 37-44, doi: 10.1503/cmaj.100248.