NCT06299956

Brief Summary

The goal of this project is to implement a protocol for a supervised exercise therapy intervention including smoking cessation in the municipalities in region Zealand in Denmark. The participants are adults with intermittent claudication. The objective of this project is to describe:

  1. 1.The development and design of the implementation process of a rehabilitative intervention including SET and smoking cessation in Region Zealand with a 6-month follow-up period after completion of the SET.
  2. 2.The ongoing quality monitoring process of the implementation in terms of referral, recruitment, retention, data completeness, intervention delivery and attendance and to collect feedback that will guide refinements of the intervention delivery and data collection.
  3. 3.Outcomes available for assessment of benefits and harms from the SET intervention.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
32mo left

Started Sep 2023

Longer than P75 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

Study Progress50%
Sep 2023Jan 2029

Study Start

First participant enrolled

September 1, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 8, 2024

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

May 25, 2025

Status Verified

May 1, 2025

Enrollment Period

5.3 years

First QC Date

March 1, 2024

Last Update Submit

May 20, 2025

Conditions

Intermittent Claudication

Keywords

Exercise therapySmoking cessationImplementationStakeholdersWalkingTreadmill

Outcome Measures

Primary Outcomes (1)

  • Maximal Walking Distance

    Treadmill test 3.2 km/h and 0% inclination for 2 min. Then the inclination will incline 2% every 2 min until the patient cannot walk further. The distance is noted in meters.

    Baseline, 12 weeks and 6 months from end of intervention

Secondary Outcomes (2)

  • Pain-free walking distance

    Baseline, 12 weeks and 6 months from end of intervention

  • Vascular Quality of Life Questionnaire-6 (VASCUQoL-6)

    Baseline, 12 weeks and 6 months from end of intervention

Study Arms (1)

The intervention group

OTHER

Supervised exercise therapy. Walking on a treadmill 3 times a week, for 12 weeks. Supervised by a physiotherapist.

Other: Supervised exercise therapy

Interventions

Supervised exercise therapyOTHER

Walking on a treadmill at increasing elevation and pace.

The intervention group

Eligibility Criteria

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

You may qualify if:

  • Relevant symptoms of intermittent claudication; leg pain when walking due to arteriosclerosis and relieve of symptoms during rest.
  • Distal blood pressure with an ankle-brachial index (ABI) \> 50 mmHg for non-diabetics or toe brachial index (TBI) \> 40 mmHg for diabetics.

You may not qualify if:

  • Evaluated by a vascular surgeon: patients with contraindications e.g. medical issues or comorbidity that enables a participation in SET are not referred.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PROgrez

Slagelse, 4700, Denmark

RECRUITING

Related Publications (1)

  • Hajdu SF, Bogard H, Aagaard TV, Roikjaer SG, Simony C, Dalhoff A, Houlind K, Luijk A, Ulriksen I, Jensen LT, Skou ST, Tang LH. Supervised exercise-based rehabilitation for people with intermittent claudication-Study protocol for a Danish implementation process (StRiDE). PLoS One. 2025 Jan 13;20(1):e0315577. doi: 10.1371/journal.pone.0315577. eCollection 2025.

    PMID: 39804879DERIVED

MeSH Terms

Conditions

Intermittent ClaudicationSmoking Cessation

Condition Hierarchy (Ancestors)

Peripheral Arterial DiseasePeripheral Vascular DiseasesVascular DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsHealth BehaviorBehavior

Study Officials

  • Helle Bøgard

    Slagelse Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Helle Bøgard

CONTACT

+4521128969hboga@regionsjaelland.dk

Lars Tang

CONTACT

larta@regionsjaelland.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2024

First Posted

March 8, 2024

Study Start

September 1, 2023

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

January 1, 2029

Last Updated

May 25, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)