Exercise training for the treatment of post-thrombotic syndrome: the EXPO pilot trial

ISRCTN ISRCTN56430072
DOI https://doi.org/10.1186/ISRCTN56430072
Secondary identifying numbers MCT-82338
Submission date
09/05/2008
Registration date
09/05/2008
Last edited
25/01/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Susan Rebecca Kahn
Scientific

Sir Mortimer B. Davis Jewish General Hospital
3755 Cote Ste. Catherine, rm A-127
Montreal, Quebec
H3T 1E2
Canada

Phone +1 514 340 8222 ext. 4667
Email susan.kahn@mcgill.ca

Study information

Study designMulticentre, two-arm randomised parallel trial with outcome assessor and data analyst blinding
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleExercise training for the treatment of post-thrombotic syndrome: a multicentre, two-arm randomised controlled parallel trial
Study acronymEXPO
Study objectivesIn 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(s)Research Ethics Committee of the Sir Mortimer B. Davis Jewish General Hospital (Canada) approved on the 13th October 2006 (ref: 06-080).
Health condition(s) or problem(s) studiedPost-thrombotic syndrome
InterventionActive 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 typeOther
Primary outcome measureFeasibility 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 measures1. 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 study start date01/03/2006
Completion date30/09/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants44
Key inclusion criteria1. 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)
Key exclusion criteria1. 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)
Date of first enrolment01/03/2006
Date of final enrolment30/09/2008

Locations

Countries of recruitment

  • Canada

Study participating centre

Sir Mortimer B. Davis Jewish General Hospital
Montreal, Quebec
H3T 1E2
Canada

Sponsor information

Sir Mortimer B. Davis Jewish General Hospital (Hôpital Général Juif Sir Mortimer B. Davis) (Canada)
Hospital/treatment centre

3755 Côte Ste-Catherine Road
Montreal, Quebec
H3T 1E2
Canada

Phone +1 514 340 8222 ext. 5252
Email razoulay@jgh.mcgill.ca
Website http://www.jgh.ca
ROR logo "ROR" https://ror.org/056jjra10

Funders

Funder type

Research organisation

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-82338)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 11/01/2011 Yes No