Aerobic ExerciseNCT07873541
Comparison of Different Exercise Protocols for Diagnosed With Lipedema
A study testing High-Intensity Interval Aerobic Exercise Group and Moderate Intensity Continuous Group in people with Aerobic Exercise and Lipedema, run by Hitit University at 1 site in Turkey (Türkiye).
Trial summary
This study was designed to compare the effects of high-intensity interval training and moderate-intensity continuous training on functional capacity, muscle strength, and quality of life in patients with lipedema, and to determine the most effective exercise training protocol for this population. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Aerobic Exercise, Lipedema
- What is being tested?
- High-Intensity Interval Aerobic Exercise Group and Moderate Intensity Continuous Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Sep 2026to 11 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-65 years and diagnosed with lipedema.
- Have not participated in a structured exercise training program within the previous 3 months.
- Voluntarily agree to participate in the study and provide informed consent.
Who cannot join
- Presence of cardiopulmonary, rheumatologic, or neurological conditions causing symptoms of sufficient severity to prevent participation in the exercise program.
- History of cancer or presence of thyroid disorders.
- Presence of edema primarily attributable to conditions other than lipedema, including lymphedema, venous edema, or edema secondary to heart or renal failure.
- Body mass index (BMI) > 50.0 kg/m².
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hitit University
Çorum, 19000
Hitit University Faculty of Medicine, +09 0364 222 11 00, tipfak@hitit.edu.tr
About this study
Official title: Comparison of the Effects of High-intensity Interval Training and Moderate-intensity Continuous Training on Functional Capacity, Muscle Strength, and Quality of Life in Patients Diagnosed With Lipedema
This study was designed to compare the effects of high-intensity interval training and moderate-intensity continuous training on functional capacity, muscle strength, and quality of life in patients with lipedema, and to determine the most effective exercise training protocol for this population.
- Conditions
- Aerobic Exercise, Lipedema
- Being tested
- High-Intensity Interval Aerobic Exercise Group, Moderate Intensity Continuous Group
- Keywords
- lipedema, aerobic exercise training, functional capacity, muscle strength, quality of life
- Medical subject headings
- Lipedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Intensity Interval Aerobic Exercise GroupOther
High-intensity interval lower-extremity aerobic exercise training will be performed on a cycle ergometer for a total duration of 35 minutes. The exercise protocol will consist of a 5-minute warm-up period at 50% of maximum heart rate, a 4 × 4-minute high-intensity training period at 80-95% of maximum heart rate, a 3 × 3-minute active recovery period at 70% of maximum heart rate, and a 5-minute cool-down period at 50% of maximum heart rate.
Moderate Intensity Continuous GroupOther
Moderate-intensity continuous lower-extremity aerobic exercise training will be performed on a cycle ergometer for a total duration of 35 minutes. The exercise protocol will consist of a 5-minute warm-up period at 50% of maximum heart rate, a 25-minute moderate-intensity training period at 65-70% of maximum heart rate, and a 5-minute cool-down period at 50% of maximum heart rate.
| Study group | Role | What they receive |
|---|---|---|
| High-Intensity Interval Aerobic Exercise Group | Experimental | High-intensity interval lower-extremity aerobic exercise training will be performed on a cycle ergometer for a total duration of 35 minutes. The exercise protocol will consist of a 5-minute warm-up period at 50% of maximum heart rate, a 4 × 4-minute high-intensity training period at 80-95% of maximum heart rate, a 3 × 3-minute active recovery period at 70% of maximum heart rate, and a 5-minute cool-down period at 50% of maximum heart rate. Receives: Other: High-Intensity Interval Aerobic Exercise Group |
| Moderate-Intensity Continuous Aerobic Exercise Group | Experimental | Moderate-intensity continuous lower-extremity aerobic exercise training will be performed on a cycle ergometer for a total duration of 35 minutes. The exercise protocol will consist of a 5-minute warm-up period at 50% of maximum heart rate, a 25-minute moderate-intensity training period at 65-70% of maximum heart rate, and a 5-minute cool-down period at 50% of maximum heart rate. Receives: Other: Moderate Intensity Continuous Group |
| Control Group | No intervention | No intervention will be performed; exercise recommendations will be provided only during routine control. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional capacity
Functional capacity will be assessed using symptom-limited maximal cardiopulmonary exercise testing (CPET), which is considered the gold-standard method for evaluating exercise capacity. CPET will be performed on a cycle ergometer (Corival CPET, Lode, Groningen, the Netherlands).
Measured: Baseline and after treatment (6 weeks)
Handgrip strength
Hand grip strength will be assessed using a hydraulic hand dynamometer (Baseline Hydraulic Hand Dynamometer, Model 12-0240, Fabrication Enterprises Inc., White Plains, NY, USA). Measurements will be performed in a seated position with the shoulder adducted, the elbow flexed at 90°, and the forearm in a neutral position. Three measurements will be performed for each hand (right and left), and the highest value obtained from each side will be recorded for statistical analysis.
Measured: Baseline and after treatment (6 weeks)
Health-related quality of life
Quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36). The SF-36 is a patient-centered, general health assessment instrument designed to evaluate an individual's overall perception of health and quality of life. It consists of 36 items covering eight domains: physical functioning, role limitations due to physical health problems, role limitations due to emotional problems, vitality, social functioning, bodily pain, general health perceptions, and mental health. The questionnaire includes 11 questions, and each domain is scored on a scale ranging from 0 to 100. Higher scores indicate better perceived health and quality of life.
Measured: Baseline and after treatment (6 weeks)
Secondary outcomes (2)
Fatigue
Fatigue will be assessed using the Fatigue Severity Scale (FSS). The FSS is a 9-item scale designed to assess the severity of fatigue and its impact on daily activities and lifestyle in individuals with various health conditions. Each item is rated on a 7-point scale ranging from 1 (strongly disagree) to 7 (strongly agree). The total score ranges from 9 to 63, with higher scores indicating greater fatigue severity.
Measured: Baseline and after treatment (6 weeks)
Anxiety and Depression
Anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale (HADS). The HADS is a self-administered instrument developed to identify the risk and severity of anxiety and depression and to assess changes in symptom severity among patients with physical illnesses and individuals attending primary healthcare services. The scale consists of 14 items divided into two subscales: anxiety (HADS-A) and depression (HADS-D), with 7 items in each subscale. Each subscale is scored from 0 to 21, with higher scores indicating greater severity of anxiety or depression. Cut-off scores of ≥10 for the anxiety subscale and ≥7 for the depression subscale have been established to indicate clinically relevant symptoms.
Measured: Baseline and after treatment (6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study start11 Sep 2026
- Primary completion11 Sep 2027 (estimated)
- Study completion11 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aerobic ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hitit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayla Cagliyan Turk, Hitit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07873541
- Sponsor's protocol ID
- 2026-20
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of High-intensity Interval Training and Moderate-intensity Continuous Training on Functional Capacity, Muscle Strength, and Quality of Life in Patients Diagnosed With Lipedema
- ClinicalTrials.gov ID
- NCT07873541
- Acronym / sponsor ID
- 2026-20
- Conditions
- Aerobic Exercise, Lipedema
- Keywords
- lipedema, aerobic exercise training, functional capacity, muscle strength, quality of life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Hitit UniversityUniversity, hospital or other
- Study start
- 11 Sep 2026 (actual)
- Primary completion
- 11 Sep 2027 (estimated)
- Study completion
- 11 Sep 2027 (estimated)
- First posted
- 14 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was designed to compare the effects of high-intensity interval training and moderate-intensity continuous training on functional capacity, muscle strength, and quality of life in patients with lipedema, and to determine the most effective exercise training protocol for this population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High-Intensity Interval Aerobic Exercise Group | Experimental | Other: High-Intensity Interval Aerobic Exercise GroupHigh-intensity interval lower-extremity aerobic exercise training will be performed on a cycle ergometer for a total duration of 35 minutes. The exercise protocol will consist of a 5-minute warm-up period at 50% of maximum heart rate, a 4 × 4-minute high-intensity training period at 80-95% of maximum heart rate, a 3 × 3-minute active recovery period at 70% of maximum heart rate, and a 5-minute cool-down period at 50% of maximum heart rate. |
| Moderate-Intensity Continuous Aerobic Exercise Group | Experimental | Other: Moderate Intensity Continuous GroupModerate-intensity continuous lower-extremity aerobic exercise training will be performed on a cycle ergometer for a total duration of 35 minutes. The exercise protocol will consist of a 5-minute warm-up period at 50% of maximum heart rate, a 25-minute moderate-intensity training period at 65-70% of maximum heart rate, and a 5-minute cool-down period at 50% of maximum heart rate. |
| Control Group | No intervention | –No intervention will be performed; exercise recommendations will be provided only during routine control. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18-65 years and diagnosed with lipedema.
- Have not participated in a structured exercise training program within the previous 3 months.
- Voluntarily agree to participate in the study and provide informed consent.
Key exclusion criteria (4 listed)
- Presence of cardiopulmonary, rheumatologic, or neurological conditions causing symptoms of sufficient severity to prevent participation in the exercise program.
- History of cancer or presence of thyroid disorders.
- Presence of edema primarily attributable to conditions other than lipedema, including lymphedema, venous edema, or edema secondary to heart or renal failure.
- Body mass index (BMI) > 50.0 kg/m².
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-Intensity Interval Aerobic Exercise GroupHigh-intensity interval lower-extremity aerobic exercise training will be performed on a cycle ergometer for a total duration of 35 minutes. The exercise protocol will consist of a 5-minute warm-up period at 50% of maximum heart rate, a 4 × 4-minute high-intensity training period at 80-95% of maximum heart rate, a 3 × 3-minute active recovery period at 70% of maximum heart rate, and a 5-minute cool-down period at 50% of maximum heart rate. | Other | High-Intensity Interval Aerobic Exercise Group |
| Moderate Intensity Continuous GroupModerate-intensity continuous lower-extremity aerobic exercise training will be performed on a cycle ergometer for a total duration of 35 minutes. The exercise protocol will consist of a 5-minute warm-up period at 50% of maximum heart rate, a 25-minute moderate-intensity training period at 65-70% of maximum heart rate, and a 5-minute cool-down period at 50% of maximum heart rate. | Other | Moderate-Intensity Continuous Aerobic Exercise Group |
Primary outcome
Functional capacity
Time frame: Baseline and after treatment (6 weeks)
Functional capacity will be assessed using symptom-limited maximal cardiopulmonary exercise testing (CPET), which is considered the gold-standard method for evaluating exercise capacity. CPET will be performed on a cycle ergometer (Corival CPET, Lode, Groningen, the Netherlands).
Handgrip strength
Time frame: Baseline and after treatment (6 weeks)
Hand grip strength will be assessed using a hydraulic hand dynamometer (Baseline Hydraulic Hand Dynamometer, Model 12-0240, Fabrication Enterprises Inc., White Plains, NY, USA). Measurements will be performed in a seated position with the shoulder adducted, the elbow flexed at 90°, and the forearm in a neutral position. Three measurements will be performed for each hand (right and left), and the highest value obtained from each side will be recorded for statistical analysis.
Health-related quality of life
Time frame: Baseline and after treatment (6 weeks)
Quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36). The SF-36 is a patient-centered, general health assessment instrument designed to evaluate an individual's overall perception of health and quality of life. It consists of 36 items covering eight domains: physical functioning, role limitations due to physical health problems, role limitations due to emotional problems, vitality, social functioning, bodily pain, general health perceptions, and mental health. The questionnaire includes 11 questions, and each domain is scored on a scale ranging from 0 to 100. Higher scores indicate better perceived health and quality of life.
2 secondary outcomes
Fatigue
Time frame: Baseline and after treatment (6 weeks)
Anxiety and Depression
Time frame: Baseline and after treatment (6 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Intensity Interval Aerobic Exercise Group and Moderate Intensity Continuous Group in people with Aerobic Exercise and Lipedema, run by Hitit University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ayla Cağlıyan Turk (+095334314171, drayla1976@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional capacity (time frame: Baseline and after treatment (6 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.