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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-06

Study Completion Date

2018-11-13

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Lymphedema of Leg Cancer of Cervix Cancer, Ovarian Cancer, Endometrial Cancer of the Prostate Malignant Melanoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

All participants complete a baseline assessment followed by the randomisation to HIIT + compression or HIIT - compression.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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HIIT + compression

2 sessions of High Intensity Interval Training (HIIT) on a stationary bike. First exercise session with compression garments/second without.

Group Type OTHER

First exercise session + compression

Intervention Type OTHER

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.

HIIT - compression

2 sessions of High Intensity Interval Training (HIIT) on a stationary bike. First exercise session without compression garments/second with

Group Type OTHER

First exercise session - compression

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Merete Celano Wittenkamp

Pricipal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Merete C Wittenkamp, PT

Role: PRINCIPAL_INVESTIGATOR

Department of Physiotherapy and Occupational Therapy at Herlev and Gentofte Hospital,

Carsten B Juhl, PT MPH PhD

Role: STUDY_CHAIR

Department of Physiotherapy and Occupational Therapy, Herlev and Gentofte Hospital/Research Unit for Musculoskeletal Function and Physiotherapy, University of Southern Denmark.