NCT05744843

Brief Summary

The goal of this pilot study and randomised control trial is to compare a smartphone-based exercise programme to deep venous stenting in patients with Post Thrombotic Syndrome. The main questions it aims to answer are:

  • Is exercise as effective as stenting in these patients?
  • What type of exercise is useful in these patients?
  • Can exercise be used to improve the results from surgery? Participants will be split into two groups at random. They will complete a smartphone-based exercise programme or have a deep venous stent. They will do the following tests before and after.
  • Exercise testing
  • Calf muscle strength and function tests
  • Ultrasound of the deep veins
  • Quality of life questionnaires
  • Clinical assessment of their disease They will be compared to healthy volunteers in the pilot study. Investigators will compare exercise to stenting to see if it improves symptoms in these patients. The pilot study will help decide how many patients are needed and what exercise tests will be used for the Randomised control trial.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 27, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

September 5, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

September 13, 2023

Status Verified

February 1, 2023

Enrollment Period

2.1 years

First QC Date

January 25, 2023

Last Update Submit

September 11, 2023

Conditions

Post Thrombotic Syndrome

Keywords

deep venousexerciseremotestenting

Outcome Measures

Primary Outcomes (1)

  • Villalta score.

    0-30, \>5 diagnostic of post thrombotic disease. 5-9 is mild disease, 9-4 moderate and \>15 Severe. (15 automatically added in the presence of a venous leg ulcer). Change in Villalta score

    1) Day 0 - baseline, prior to intervention. 2) up to 2 weeks post intervention, on average week 8-12 of the study. 3) Study completion, 6 months

Secondary Outcomes (5)

  • VO2 max - maximal oxygen consumption

    1) Day 0 - baseline, prior to intervention. 2) up to 2 weeks post intervention, on average week 8-12 of the study.

  • Six minute walk test

    1) Day 0 - baseline, prior to intervention. 2) up to 2 weeks post intervention, on average week 8-12 of the study.

  • Incline walk test

    1) Day 0 - baseline, prior to intervention. 2) up to 2 weeks post intervention, on average week 8-12 of the study.

  • Calf ejection fraction

    1) Day 0 - baseline, prior to intervention. 2) up to 2 weeks post intervention, on average week 8-12 of the study.

  • Venous Insufficiency Epidemiological and Economic Study quality of life and symptoms (VEINES-QoL/Sym) - disease specific quality of life instrument for Chronic Venous Disorders of the Leg

    1) Day 0 - baseline, prior to intervention. 2) up to 2 weeks post intervention, on average week 8-12 of the study. 3) Study completion, 6 months

Other Outcomes (2)

  • Maximal calf isometric contract strength as measured by isometric dynamometry.

    1) Day 0 - baseline, prior to intervention. 2) up to 2 weeks post intervention, on average week 8-12 of the study.

  • deep venous flow velocity

    1) Day 0 - baseline, prior to intervention. 2) up to 2 weeks post intervention, on average week 8-12 of the study.

Study Arms (3)

Smartphone-based exercise arm

EXPERIMENTAL

Eight to twelve week smartphone delivered exercise programme

Behavioral: exercise

Stenting Arm

ACTIVE COMPARATOR

Deep venous stenting as standard of care

Procedure: Deep venous stenting

Healthy Volunteers

NO INTERVENTION

Healthy Volunteers for baseline testing

Interventions

exerciseBEHAVIORAL

cardiovascular and lower limb strengthening exercise programme

Also known as: remote exercise programme, smartphone-based exercise programme
Smartphone-based exercise arm
Deep venous stentingPROCEDURE

Planned surgical intervention

Also known as: Endovascular Stent reconstruction of Deep Vein
Stenting Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with symptomatic chronic venous outflow obstruction secondary to PTS or other cause affecting the Inferior Vena Cava (IVC) or iliofemoral vein(s) for greater than 12 months duration AND clinical indication for Deep Venous Stenting.

You may not qualify if:

  • Deep Vein Thrombosis or Pulmonary Embolism within the last 12 months
  • Significant or untreated left sided heart disease
  • Significant or untreated respiratory disease
  • Significant renal disease
  • Significant liver disease
  • Significant Musculoskeletal or Neurological disease
  • Active cancer
  • Life expectancy of less than 2 years or non-ambulatory status
  • Current or Planned pregnancy within the study period
  • Any other contraindication to exercise
  • Any impairment preventing the provision of informed consent and compliance with study protocol
  • Healthy Volunteers in the control group with presence of any arterial or venous disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Thomas' Hospital, Guy's and St. Thomas' NHS Foundation Trust

London, SE1 7EH, United Kingdom

RECRUITING

Related Publications (1)

  • Flumignan RL, Nakano LC, Flumignan CD, Baptista-Silva JC. Angioplasty or stenting for deep venous thrombosis. Cochrane Database Syst Rev. 2025 Feb 19;2(2):CD011468. doi: 10.1002/14651858.CD011468.pub2.

    PMID: 39968829DERIVED

MeSH Terms

Conditions

Postthrombotic SyndromeMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Venous ThrombosisThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesVenous InsufficiencyBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Stephen A Black, FRCS

    St Thomas' Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ehsanul K Choudhury, MRCS

CONTACT

+44 20 7188 7188ehsanul.choudhury@gstt.nhs.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2023

First Posted

February 27, 2023

Study Start

September 5, 2023

Primary Completion

October 1, 2025

Study Completion

April 1, 2026

Last Updated

September 13, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)