High Intensity Interval Training (HIIT) for Patients With Cancer-related Lymphedema in the Lower Limbs

Malignant Melanoma Clinical Trial

Official title:

High Intensity Interval Training (HIIT) on Stationary Bike With and Without Compression Stockings for Patients With Cancer-related Lymphedema in the Lower Limbs - a Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03653819
• Other study ID #: Lympha feasibility
• Status: Completed
• Phase: N/A
• Start date: September 6, 2018
• Est. completion date: November 13, 2018

Study information

• Verified date: November 2018
• Source: Herlev and Gentofte Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to explore the feasibility and safety of High Intensity Interval Training on a stationary bike for patients with lymphedema in the lower limbs and the role of compression garments during exercise.

The design of the study is a cross-over randomized clinical trial. Participants will be randomized into two groups. Both will perform two separate exercise sessions.Group A will perform the first exercise with compression garment and the second session without compression garment, with wash-out period of 1 week between sessions. Group B will perform the exercise sessions in the opposite order.

Description:

Lymphedema is a condition afflicting cancer patients who undergo surgery with removal of lymph nodes, chemotherapy and radiation. Lymphedema is a consequence of impaired lymphatic drainage in the interstitium, which causes edema and inflammation in the subcutaneous tissue. The symptoms are swelling, puffiness, tightness, heaviness and pain in the affected area.

Lymphedema can be reduced by complete decongestive therapy, which consists of skin care, manual lymphatic drainage, compression bandaging and exercise. At the end of treatment, patients are provided with custommade compression garments to be worn during daytime in order to maintain the reduction in the edema.

Lymphedema has a negative impact on activities of daily living and health-related quality of life. Patients with lymphedema should be encouraged to engage in physical activity despite their condition in order to prevent relapse of cancer and development of other diseases. Likewise physical activity helps to maintain a healthy weight, which is important as obesity has a negative impact on lymphedema. The lymphatic system is also stimulated by physical activity and exercise and can reduce the symptoms from the lymphedema.

Several studies have been published on the safety and benefits of exercise for women with breastcancer related lymphedema. However, only a few studies have investigated the feasibility of exercise to patients with lymphedema in the lower limbs. Also the role of compression garments during exercise have not been throughly explored.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 13, 2018
• Est. primary completion date: November 13, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• unilateral or bilateral lymphedema in the lower limbs

• secondary lymphedema

• wears custommade compression stockings during daytime

• lymphedema in stage 1, 2A or 2B (Classification from the International Society of Lymphology)

• legally competent persons with ability to read and understand Danish.

Exclusion Criteria:

• inability to perform the intervention, as assessed by the person performing inclusion.

• lymphedema in stage 0 or 3 (Classification from the International Society of Lymphology)

• ongoing complete decongestive lymphedema therapy

• untreated erysipelas

• ongoing oncologic treatment: chemotherapy, radiation, immune therapy,

• known metastatic cancer

• comorbidities e.g. deep venenous thrombosis, serious heart disease, renal insufficiency

Related Conditions & MeSH terms

• Cancer of Cervix
• Cancer of the Prostate
• Cancer, Endometrial
• Cancer, Ovarian
• Endometrial Neoplasms
• Lymphedema
• Lymphedema of Leg
• Malignant Melanoma
• Melanoma
• Ovarian Neoplasms
• Prostatic Neoplasms
• Uterine Cervical Neoplasms

Intervention

Other:
• First exercise session + compression
The Interval Training consists of a 5 minute warm-up on the stationary bike followed by 7 intervals of cycling for 1 minute at level 15-16 on the Borg Scale of Perceived Exertion. Inbetween intervals, participants reduce resistance on the stationary bike and pedals for 1 minute at level 11-12 on the Borg Scale. The session ends with a 5-10 minute cool-down pedaling and stretching exercises for the lower limbs.
• First exercise session - compression
The Interval Training consists of a 5 minute warm-up on the stationary bike followed by 7 intervals of cycling for 1 minute at level 15-16 on the Borg Scale of Perceived Exertion. Inbetween intervals, participants reduce resistance on the stationary bike and pedals for 1 minute at level 11-12 on the Borg Scale. The session ends with a 5-10 minute cool-down pedaling and stretching exercises for the lower limbs.

Locations

Country	Name	City	State
Denmark	Department of Physiotherapy and Occupational Therapy, Herlev and Gentofte Hospital	Herlev

Sponsors (2)

Lead Sponsor	Collaborator
Herlev and Gentofte Hospital	University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility rate	Number of invited eligible participants enrolled in the study	After 3 months
Primary	Completion rate	Number of enrolled participants completing both interventions	After 3 months
Secondary	Participant satisfaction	At the end of the study participation, data describing participant satisfaction will be collected to answers questions on acceptability. All participants will be given a questionnaire and will be asked to rank various aspects of the intervention including exercising without compression garments "as not at all satisfied", "not very satisfied", "somewhat satisfied" or "very satisfied". Feasibility will be defined as >75% of participants reporting they are "very" or "somewhat satisfied" with the intervention.	Week 2
Secondary	Change in pain related to lymphedema	Participant-reported pain measured on a numeric range scale 0-10, "0" indicating no pain and "10" as worst imaginable pain. Measurements will be made immediately before and after each exercise session.	Hour 0 and 1 post each exercise sessions
Secondary	Change in tension related to lymphedema	Participant-reported tension measured on a numeric range scale 0-10, "0" indicating no tension and "10" worst imaginable tension. Measurements will be made immediately before and after each exercise session.	Hour 0 and 1 post each exercise sessions
Secondary	Change in heaviness related to lymphedema	Participant-reported heaviness measured on a numeric range scale 0-10, "0" indicating no heaviness and "10" worst imaginable heaviness. Measurements will be made immediately before and after each exercise session.	Hour 0 and 1 post each exercise sessions
Secondary	Change in volume of lower limbs	Tape Measurements(cm) at 8 cm intervals, converted to volume (ml) by formula of truncated cone. Measurements will be made immediately before and after each exercise session	Hour 0 and hour 1 post each exercise sessions
Secondary	Change in extracellular fluid in the lower limbs	Bioimpedance Spectroscopy. Measurements will be made immediately before and after each exercise session.	Hour 0 and hour 1 post each exercise session
Secondary	Change in weight of the lower limbs	Dual Energy Xray Absorptiometry, a full body scan is performed. Afterwards regions of interest is marked and weight of each lower limb calculated. Measurements will be made immediately before and after each exercise session.	Hour 0 and hour 1 post each exercise session