Clinical trial NCT06727968: Adding a Combined Program of Therapeutic Exercise and Self-massage to the Conventional Approach of Compression Stockings and Preventive Measures in Chronic Venous Insufficiency.
Official title: Adding a Combined Program of Therapeutic Exercise and Self-massage to the Conventional Approach of Compression Stockings and Preventive Measures in Chronic Venous Insufficiency. a Randomized Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Venous Insufficiency, CVI
Keywords: Therapeutic exercise
Massage
Compression Stocking
Physiotherapy
Lead sponsor: University of Valencia
Sponsor class: OTHER
Collaborators: name: Hospital General Valencia
First posted: 2024-12-11
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate whether the inclusion of a physiotherapy approach in primary care consultation prescribing exercises and teaching self-massage techniques would be well accepted by patients of chronic venous insufficiency and provide higher benefits in the self-management.

Detailed description: This study aimed at comparing the effects of conventional therapy approaches based on compression stocking and prevention measures with a combined program of these techniques added to therapeutic exercise and self-massage explained by a physiotherapist on on functionality, general physical activity and oedema of people with CVI. In this sense, a randomized controlled trial two armed group was designed.

Eligibility criteria: Inclusion Criteria:

1. Diagnosed of CVI
2. aged between 18 and 85 years and
3. with mobile or email address to send the study information and follow-up

Exclusion Criteria:

1. Mental or psychological condition that impairs the study development
2. comorbidities that impair the physical activity performance
3. surgical interventions during the 6 previous months before the intervention or during the study development
4. deep vein thrombosis
5. active leg ulcer
6. pregnancy.

Primary outcomes:
measure: Edema
timeFrame: Pre-intervention and after 16 weeks of intervention
measure: Functionality in gait
timeFrame: Pre-intervention and after 16 weeks of intervention
measure: Physical Activity Level
timeFrame: Pre-intervention and after 16 weeks of intervention
measure: Prevention measures employed
timeFrame: Pre-intervention and after 16 weeks of intervention
measure: Functionality of lower limbs
timeFrame: Pre-intervention and after 16 weeks of intervention
Secondary outcomes:
measure: CVI symptoms and severity
timeFrame: Baseline
measure: Satisfaction with the treatment
timeFrame: After 16 weeks of intervention
measure: Adherence to treatment
timeFrame: After 16 weeks of intervention
Other outcomes:
measure: Demographic information
timeFrame: Baseline
measure: Clinical measures
timeFrame: Baseline
measure: Comorbidies
timeFrame: Baseline
measure: Smoking habit
timeFrame: Baseline
Locations:
city: Valencia
country: Spain
facility: Spain
Study officials:
References: