Comparison of the Effects of Kinesio Taping and Interval Exercise in Patients Diagnosed With Venous Insufficiency: A Randomised Controlled Trial

NCT07228585 | Active Not Recruiting

• 1 other identifier: 25936
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the effects of kinesiology taping and interval exercise on reducing symptoms, improving quality of life, and vital parameters in individuals with venous insufficiency. The study will be conducted at the Department of Cardiovascular Surgery, Faculty of Medicine, Necmettin Erbakan University, Konya, and will involve individuals aged 18 to 65 who have been diagnosed with venous insufficiency. Participants will be selected according to inclusion criteria and randomised into three groups. These groups will consist of a group receiving kinesiology taping and lifestyle recommendations, a group receiving kinesiology taping combined with interval exercise and lifestyle recommendations, and a control group receiving only lifestyle recommendations. Participants will be followed up for eight weeks, with assessments conducted twice: before and after treatment. In kinesiology taping groups, taping will be applied twice a week for eight weeks, with a total of sixteen sessions. During application, the lymphatic correction technique will be used to increase venous circulation. Taping will begin over the popliteal vein and be applied along the gastrocnemius, soleus, and tibialis posterior muscles with a tension of fifteen to twenty per cent. Participants will inform the physiotherapist if they experience any discomfort or skin sensitivity related to the bandaging, and skin reactions and tolerance levels will be monitored during weekly check-ups. In the group undergoing interval exercise, participants will participate in a mild to moderate exercise programme for thirty to forty minutes, three days a week for eight weeks. The exercises will be performed under the supervision of a physiotherapist and will be of an intensity equivalent to levels three to five on the Borg scale. The programme will include a five-minute warm-up phase, a twenty-minute main exercise section, and a five-minute cool-down period. The main section will consist of three phases, with low-intensity, moderate-intensity, and recovery exercises applied alternately. In the low-intensity section, light-paced walking and step movements will be performed; in the moderate-intensity section, fast-paced walking, ankle pumping movements, squats or calf raises will be performed; in the recovery section, light walking or wrist movements will be preferred. The main exercise will be completed after the cycle is repeated four times, followed by light stretching movements and diaphragmatic breathing exercises during the cool-down phase. Exercise compliance will be monitored on a weekly basis. Standard lifestyle recommendations will be provided to all groups participating in the study. As lifestyle changes in venous insufficiency have both therapeutic and symptom-reducing effects, participants will be given detailed information on this subject. Lifestyle recommendations include increasing physical activity habits such as walking briskly for at least thirty minutes daily and using stairs. As part of leg elevation recommendations, it will be advised to keep the legs above heart level for fifteen to twenty minutes, two or three times a day. Individuals whose jobs require them to stand still for long periods will be advised to take a short walk every thirty minutes. Nutritional recommendations will emphasise reducing salt intake, drinking at least two litres of water daily, and eating fibre-rich foods. Smoking participants will be counselled to quit and asked to avoid wearing tight trousers and high-heeled shoes. As part of skin care, participants will be instructed to use moisturiser once a day to prevent dryness and cracking in the lower extremities. Lifestyle recommendations will be presented to participants via a brochure, and participants in the control group will also follow the same recommendations. The conditions of the study and safety measures have been determined with great care. All procedures will be performed by experienced physiotherapists, taking into account the participants' medical history and contraindications. Assessments will be conducted twice: at the beginning and at the end of the eight-week period. Measurements will include ankle circumference, pain intensity at rest, during sleep and during exercise, blood pressure, heart rate, respiratory rate, body temperature, oxygen saturation, Borg scale assessment, physical activity level measurement, functional capacity assessment, central sensitisation level and quality of life in venous insufficiency. The six-minute walk test will be used to assess functional capacity, the visual analogue scale will be applied for pain, this parameter will be examined using the central sensitisation inventory, and quality of life will be assessed using scales specific to venous insufficiency. The International Physical Activity Questionnaire will be used for physical activity level.

Conditions

Chronic Venous Insufficiency C2 and Below

Keywords

venous insufficiency; kinesiology tape; interval training; lifestyle recommendations; physiotherapy and rehabilitation; physiotherapy

Outcome Measures

Primary Outcomes (1)

• Change in Central Sensitization Inventory (CSI Part A Score)

  Central sensitization symptoms will be assessed using the Central Sensitization Inventory (CSI) Part A. Total score ranges from 0 to 100, with higher scores indicating greater central sensitization. Time Frame: At baseline (before intervention) and after 8 weeks of intervention.

  At baseline (before intervention) and after 8 weeks of intervention.

Secondary Outcomes (6)

• Change in Central Sensitization Inventory (CSI Part B)

  At baseline (before intervention) and after 8 weeks of intervention.

• Change in Venous Insufficiency-Specific Quality of Life (VEINES-QOL/Sym)

  At baseline (before intervention) and after 8 weeks of intervention.

• Change in Pain Intensity (Visual Analog Scale, VAS)

  At baseline (before intervention) and after 8 weeks of intervention.

• Change in Functional Capacity (6-Minute Walk Test)

  At baseline (before intervention) and after 8 weeks of intervention.

• Change in Perceived Exertion (Modified Borg Scale)

  At baseline (before intervention) and after 8 weeks of intervention.

Study Arms (3)

Active Comparator: KT + Advice

ACTIVE COMPARATOR

Participants receive lifestyle modification advice for venous insufficiency, including reducing prolonged standing, interrupting sitting with leg movements, and elevating legs above heart level. All participants are advised on daily physical activity (at least 30 minutes of brisk walking), leg elevation (2-3 times for 15-20 minutes), low-salt and high-fiber diet, hydration, smoking cessation, and skin care. Kinesio taping is applied using lymphatic correction techniques from the popliteal area to the lower leg (15-20% tension), changed twice weekly for eight weeks.

Behavioral: Kinesio Taping and Lifestyle Advice

Experimental: KT + Exercise + Advice

EXPERIMENTAL

Participants receive standard lifestyle advice as described for venous insufficiency and Kinesio taping using lymphatic correction techniques (popliteal to lower leg, covering gastrocnemius, soleus, and tibialis posterior, 15-20% tension). Tape is replaced twice weekly for eight weeks. Interval exercise is performed three times weekly for 30-40 minutes, consisting of warm-up, alternating low- and moderate-intensity phases, and cool-down with stretching and diaphragmatic breathing. Weekly monitoring ensures safety and adherence.

Behavioral: Kinesio Taping and Interval Exercise with Lifestyle Advice

Active Comparator: Advice Only

ACTIVE COMPARATOR

Participants receive comprehensive lifestyle modification advice for venous insufficiency, including reduction of prolonged standing, frequent leg movements, leg elevation above heart level, regular physical activity, low-salt and high-fiber diet, hydration, smoking cessation, suitable clothing, and skin moisturizing. All guidance is delivered by physiotherapists, considering individual medical history and contraindications

Behavioral: Lifestyle Advice for Venous Insufficiency

Interventions

Kinesio Taping and Lifestyle Advice BEHAVIORAL

Participants receive lifestyle modification advice for venous insufficiency, including reducing prolonged standing, interrupting sitting with leg movements, and elevating legs above heart level. All participants are advised on daily physical activity (at least 30 minutes of brisk walking), leg elevation (2-3 times for 15-20 minutes), low-salt and high-fiber diet, hydration, smoking cessation, and skin care. Kinesio taping is applied using lymphatic correction techniques from the popliteal area to the lower leg (15-20% tension), changed twice weekly for eight weeks.

Active Comparator: KT + Advice

Kinesio Taping and Interval Exercise with Lifestyle Advice BEHAVIORAL

Participants receive standard lifestyle advice as described for venous insufficiency and Kinesio taping using lymphatic correction techniques (popliteal to lower leg, covering gastrocnemius, soleus, and tibialis posterior, 15-20% tension). Tape is replaced twice weekly for eight weeks. Interval exercise is performed three times weekly for 30-40 minutes, consisting of warm-up, alternating low- and moderate-intensity phases, and cool-down with stretching and diaphragmatic breathing. Weekly monitoring ensures safety and adherence.

Experimental: KT + Exercise + Advice

Lifestyle Advice for Venous Insufficiency BEHAVIORAL

Participants receive comprehensive lifestyle modification advice for venous insufficiency, including reduction of prolonged standing, frequent leg movements, leg elevation above heart level, regular physical activity, low-salt and high-fiber diet, hydration, smoking cessation, suitable clothing, and skin moisturizing. All guidance is delivered by physiotherapists, considering individual medical history and contraindications.

Active Comparator: Advice Only

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals aged 18-65
• Individuals diagnosed with chronic venous insufficiency (those in stages 0-2 of the CEAP classification)
• Individuals with no barriers to participating in physical activity
• Individuals who can read and understand Turkish and have no communication difficulties
• Individuals with no allergy to kinesiology taping in the kinesiology taping group

You may not qualify if:

• Diagnosis of acute venous thrombosis
• History of serious cardiovascular disease
• Pregnancy or breastfeeding
• Presence of active infection
• Those who do not wish to continue participating in the study

Sponsors & Collaborators

• Necmettin Erbakan University: lead

Study Sites (1)

Necmettin Erbakan University

Konya, Selçuklu, 42130, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Venous Insufficiency

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist (MSc student in Physiotherapy and Rehabilitation)

Model Details: The interventional study model evaluates the effects of specific treatments on defined groups. It actively applies an intervention and measures outcomes such as symptoms, function, or quality of life. Randomization assigns participants to experimental or control groups to reduce bias, ensuring observed effects are due to the intervention. In physiotherapy, interventions may include exercise, taping, or manual therapy, with outcomes assessed before and after treatment. Ethical approval, informed consent, and standardized procedures are essential. Despite resource demands, this model provides reliable evidence, guiding clinical decisions and improving patient outcomes.

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 14, 2025
• Study Start: September 22, 2025
• Primary Completion: January 8, 2026
• Study Completion: April 13, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

TU (1)