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

NCT03653819 | Completed

• 1 other identifier: Lympha feasibility
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Compression Stockings; Feasibility Study; Physical Activity; High Intensity Interval Training; Cross over trial

Outcome Measures

Primary Outcomes (2)

• Feasibility rate

  Number of invited eligible participants enrolled in the study

  After 3 months

• Completion rate

  Number of enrolled participants completing both interventions

  After 3 months

Secondary Outcomes (7)

• Participant satisfaction

  Week 2

• Change in pain related to lymphedema

  Hour 0 and 1 post each exercise sessions

• Change in tension related to lymphedema

  Hour 0 and 1 post each exercise sessions

• Change in heaviness related to lymphedema

  Hour 0 and 1 post each exercise sessions

• Change in volume of lower limbs

  Hour 0 and hour 1 post each exercise sessions

Study Arms (2)

HIIT + compression

OTHER

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

Other: First exercise session + compression

HIIT - compression

OTHER

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

Other: First exercise session - compression

Interventions

First exercise session - compression 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Herlev and Gentofte Hospital: lead
• University of Copenhagen: collaborator

Study Sites (1)

Department of Physiotherapy and Occupational Therapy, Herlev and Gentofte Hospital

Herlev, 2730, Denmark

Location

Related Publications (1)

• Wittenkamp MC, Juhl CB, Zerahn B, Vinther A. Exercise and cancer-related lymphedema in the lower limbs-a randomized cross-over trial on high-intensity interval training (HIIT) with and without compression garments. Support Care Cancer. 2025 Apr 16;33(5):391. doi: 10.1007/s00520-025-09458-x.

  PMID: 40240614 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Ovarian Neoplasms; Endometrial Neoplasms; Prostatic Neoplasms; Melanoma; Motor Activity

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Endocrine System Diseases; Gonadal Disorders; Genital Neoplasms, Male; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Study Officials

• Merete C Wittenkamp, PT

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

  PRINCIPAL INVESTIGATOR

• Carsten B Juhl, PT MPH PhD

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

  STUDY CHAIR

• Anders Vinther, PT MSc PhD

  Department of Physiotherapy and Occupational Therapy, Herlev and Gentofte Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pricipal Investigator

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

Study Record Dates

• First Submitted: August 23, 2018
• First Posted: August 31, 2018
• Study Start: September 6, 2018
• Primary Completion: November 13, 2018
• Study Completion: November 13, 2018
• Last Updated: November 15, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)