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Completed

NCT Number: NCT04257643

Aquatic Versus Land Based Exercise on Lymphedema Post Mastectomy

Fifty eligible breast cancer survivors (median, 10 yrs after surgery) with arm lymph-edema (median, 21% inter limb difference) were included and randomized into the intervention(group A, n = 25) or control ( Group B, n = 25). Intervention group received 60 minutes aquatic-based exercise in the form of warm-up for 10 mins, then strengthening exercise for 40 minutes, followed by 10 min cooling down in the form of stretching and mobility exercise, three times a week for 8 weeks, plus land-based exercise session for 60 minutes for 8 weeks in the form of warm-up, strengthening, and cooling down exercise. The control group received 60 minutes of land base exercise, three times a week, for 8 weeks. Arm volume, shoulder flexion, abduction range of motion and pain using a visual analogue scale were assessed at baseline and after 8 weeks of treatment.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

30 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cairo university.

Cairo, Cairo Governorate, 0025, Egypt

About this study

Group A: 25 female Patients there aged ranged from 37 to 67 years old with BCRL, in Group-A had been dealt with water-based exercise was conducted at a hydrotherapy pool for the Eden Health care, cairo, The pool measures 8 × 15 m and ranges from 1 to 1.8 m in depth with access via steps. Interventions were conducted predominately in the deeper section of the pool so participants immerse their neck in water.

Control group, Group B: 25 female Patients there aged ranged from 37 to 67 years old with BCRL, in control group had been dealt Land-based exercise program: Supervised program consisted of 60-min sessions, three times a week, over 8 weeks. The exercise program consisted of the first 10 minutes for warm-up exercise with a small softball, fit -ball, mobility and stretching exercise. Then 30-40 minutes for strength development with different materials and positions, that require more body control and increase joint motion. Then the last 10 minutes for cooling down for stretching exercise for the arm muscles .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Breast cancer with unilateral axillary lymph node excision.
  • Mild-moderate degreed lymphedema (stage I and II) .
  • Lymphedema with a duration of at least 1 year .

Exclusion criteria

  • Recurrence of cancer.
  • Ongoing active oncological treatment.
  • Functional disorders hindering participation in exercise programs.
  • Open wound at any area of the body.

Treatment and study plan

aquatic based exercise.

Other

exercise under water with the patient standing in a swimming pool, for 60 minswith water to the neck and then practice the arm exercise plus the diaphragmatic breathing exercise. The duration of the exercise programs was selected to be 60 minutes, 3 days per week for 8-week intervention

land-based exercise.

Other

land-based exercise session for 60 minutes for 8 weeks in the form of warm-up, strengthening, and cooling down exercise.Land-based exercise program: Supervised program consisted of 60-min sessions, three times a week, over 8 weeks. The exercise program consisted of the first 10 minutes for warm-up exercise with a small softball, fit -ball, mobility and stretching exercise. Then 30-40 minutes for strength development with different materials and positions, that require more body control and increase joint motion. Then the last 10 minutes for cooling down for stretching exercise for the arm muscles [14]. Women were asked to exercise continuously for 60 mins, by performing the arm exercises by repeating the session, and were instructed to exercise at moderate intensity .

Primary outcomes

  1. Limb volume measurement:

    Time frame: 8 weeks.

    the patient in a comfortable sitting position, a standard one cm, retractable, the fibreglass tape measure was used to perform circumference measurement. The measurement was made at, 10, 20, 30, and 40 cm above the ulnar styloid process,

Secondary outcomes

  1. Range of Motion

    Time frame: 8 weeks.

    Upper extremity active ROM for shoulder flexion and abduction were assessed in the standing position using a standard goniometric method

Other outcomes

  1. Visual analogue scale for pain assessment

    Time frame: 8 weeks.

    horizontal (HVAS) or vertical (VVAS) line, usually 10 centimetres (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme. Instructions, the time period for reporting, and verbal descriptor anchors have varied widely in the literature depending on the intended use of the scale

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Efficacy of Aquatic Based Versus Land-based Exercise in Lymph Edema Post-mastectomy: a Prospective Randomized Controlled Trial.

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 6, 2020
Registry last updated
Feb 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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