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

ISRCTN	ISRCTN56430072
DOI	https://doi.org/10.1186/ISRCTN56430072
Protocol serial number	MCT-82338
Sponsor	Sir Mortimer B. Davis Jewish General Hospital (Hôpital Général Juif Sir Mortimer B. Davis) (Canada)
Funder	Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: 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

Primary study design	Interventional
Study design	Multicentre, two-arm randomised parallel trial with outcome assessor and data analyst blinding
Secondary study design	Randomised controlled trial
Scientific title	Exercise training for the treatment of post-thrombotic syndrome: a multicentre, two-arm randomised controlled parallel trial
Study acronym	EXPO
Study objectives	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(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) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	30/09/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	44
Key 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)
Key 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)
Date of first enrolment	01/03/2006
Date of final enrolment	30/09/2008

Locations

Countries of recruitment

Canada

Study participating centre

Sir Mortimer B. Davis Jewish General Hospital

Montreal, Quebec
H3T 1E2
Canada

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not 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