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
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 |
|---|---|
| susan.kahn@mcgill.ca |
Study information
| 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 |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 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 study start date | 01/03/2006 |
| Completion date | 30/09/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
H3T 1E2
Canada
Sponsor information
Sir Mortimer B. Davis Jewish General Hospital (Hôpital Général Juif Sir Mortimer B. Davis) (Canada)
Hospital/treatment centre
Hospital/treatment centre
3755 Côte Ste-Catherine Road
Montreal, Quebec
H3T 1E2
Canada
| Phone | +1 514 340 8222 ext. 5252 |
|---|---|
| razoulay@jgh.mcgill.ca | |
| Website | http://www.jgh.ca |
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
