Condition category
Circulatory System
Date applied
09/05/2008
Date assigned
09/05/2008
Last edited
25/01/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.jgh.ca

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

  1. 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.

Additional files

Editorial Notes