Dataset Information

Six-month exercise training program to treat post-thrombotic syndrome: a randomized controlled two-centre trial.

ABSTRACT:

Background

Exercise training may have the potential to improve post-thrombotic syndrome, a frequent, chronic complication of deep venous thrombosis. We conducted a randomized controlled two-centre pilot trial to assess the feasibility of a multicentre-based evaluation of a six-month exercise training program to treat post-thrombotic syndrome and to obtain preliminary data on the effectiveness of such a program.

Methods

Patients were randomized to receive exercise training (a six-month trainer-supervised program) or control treatment (an education session with monthly phone follow-ups). Levels of eligibility, consent, adherence and retention were used as indicators of study feasibility. Primary outcomes were change from baseline to six months in venous disease-specific quality of life (as measured using the Venous Insufficiency Epidemiological and Economic Study Quality of Life [VEINES-QOL] questionnaire) and severity of post-thrombotic syndrome (as measured by scores on the Villalta scale) in the exercise training group versus the control group, assessed by t tests. Secondary outcomes were change in generic quality of life (as measured using the Short-Form Health Survey-36 [SF-36] questionnaire), category of severity of post-thrombotic syndrome, leg strength, leg flexibility and time on treadmill.

Results

Of 95 patients with post-thrombotic syndrome, 69 were eligible, 43 consented and were randomized, and 39 completed the study. Exercise training was associated with improvement in VEINES-QOL scores (exercise training mean change 6.0, standard deviation [SD] 5.1 v. control mean change 1.4, SD 7.2; difference 4.6, 95% CI 0.54 to 8.7; p = 0.027) and improvement in scores on the Villalta scale (exercise training mean change -3.6, SD 3.7 v. control mean change -1.6, SD 4.3; difference -2.0, 95% CI -4.6 to 0.6; p = 0.14). Most secondary outcomes also showed greater improvement in the exercise training group.

Interpretation

Exercise training may improve post-thrombotic syndrome. It would be feasible to definitively evaluate exercise training as a treatment for post-thrombotic syndrome in a large multicentre trial.

SUBMITTER: Kahn SR

PROVIDER: S-EPMC3017252 | biostudies-literature | 2011 Jan

REPOSITORIES: biostudies-literature

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Publications

Six-month exercise training program to treat post-thrombotic syndrome: a randomized controlled two-centre trial.

Kahn Susan R SR Shrier Ian I Shapiro Stan S Houweling Adrielle H AH Hirsch Andrew M AM Reid Robert D RD Kearon Clive C Rabhi Khalil K Rodger Marc A MA Kovacs Michael J MJ Anderson David R DR Wells Philip S PS

CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne 20101122 1

<h4>Background</h4>Exercise training may have the potential to improve post-thrombotic syndrome, a frequent, chronic complication of deep venous thrombosis. We conducted a randomized controlled two-centre pilot trial to assess the feasibility of a multicentre-based evaluation of a six-month exercise training program to treat post-thrombotic syndrome and to obtain preliminary data on the effectiveness of such a program.<h4>Methods</h4>Patients were randomized to receive exercise training (a six-m ...[more]

PMID: 21098066

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Project description:Interventions: Controlled intervention will compare microbiome changes over six-months between cancer types. All participants will complete a four-week training program, supervised by an Accredited Exercise Physiologist or equivalent. This initial program will require attendance three times per week and entail a high-intensity interval training protocol of 4x4 minute intervals at 85-95% HRpeak, with three minute active recovery bouts between each interval. Attendance will be recorded in a supervised-training logbook. Similarly, adherence to 85-95% HRpeak during intervals will be recorded. This protocol requires a total of 38 minutes exercise and all exercise will be conducted on a cycle ergometer. The purpose of this period is to ensure all participants understand the exercise protocol and are able to complete it safely during the remainder of the study. Participants will then be provided with access to a facility with all required equipment available and encouraged to complete three sessions per week for the next six months. Participants will also be advised to maintain 150 minutes of moderate intensity or 75 minutes of vigorous intensity or a combination, therefore meeting the Australian exercise oncology guidelines. Participants will keep a log of the date and duration of exercise completed. Participants will be recruited from the Brisbane area, with the intervention being run from the University of Queensland and partnered gyms in the wider Brisbane area. Primary outcome(s): Human gut microbiome taxa abundance in stool samples assessed via 16S rRNA sequencing. This composite outcome will also provide representation of microbial diversity. [Participants will deposit a stool sample within the three days immediately prior to each testing occasion. Testing time-points will be at baseline (prior to supervised training), following the 4-weeks supervised training, and at three- and six-months (primary endpoint) following supervised training.] Study Design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Efficacy

Dataset Information

Six-month exercise training program to treat post-thrombotic syndrome: a randomized controlled two-centre trial.

Background

Methods

Results

Interpretation

Publications

Six-month exercise training program to treat post-thrombotic syndrome: a randomized controlled two-centre trial.

Similar Datasets

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