Aquatic Versus Land Based Exercise on Lymphedema Post Mastectomy

NCT04257643 | Completed

• 1 other identifier: P.T.REC/012/002615
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Aquatic exercise-; Land based exercise; lymphedema

Outcome Measures

Primary Outcomes (1)

• Limb volume measurement:

  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,

  8 weeks.

Secondary Outcomes (1)

• Range of Motion

  8 weeks.

Other Outcomes (1)

• Visual analogue scale for pain assessment

  8 weeks.

Study Arms (2)

Experimental group

EXPERIMENTAL

water-based exercise was conducted at a hydrotherapy pool for the Eden Heelth 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. Thermo neutral water temperature, 30-32 °C at room temperature. Females were instructed to adjust water depth completely covering clavicles from standing position. Diaphragmatic breathing during exercise routine to assist with lymph fluid clearance. Exercise continuously for 40 to 45 min Full-body warm-up exercise for 10 min and cooling down for 10 minutes. Plus land-based exercise session for 60 minutes for 8 weeks in the form of warm-up, strengthening, and cooling down exercise.

Other: aquatic based exercise.; Other: land-based exercise.

Control group

ACTIVE COMPARATOR

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

Other: land-based exercise.

Interventions

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

Experimental group

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 .

Control group; Experimental group

Eligibility Criteria

• Age: 30 Years - 60 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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 .

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo university.

Cairo, Cairo Governorate, 0025, Egypt

Location

MeSH Terms

Conditions

Breast Neoplasms; Lymphedema

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Khadra M Ali, Phd

  Cairo University, Faculty of physical Therapy.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator.

Study Record Dates

• First Submitted: January 31, 2020
• First Posted: February 6, 2020
• Study Start: July 1, 2018
• Primary Completion: November 30, 2019
• Study Completion: November 30, 2019
• Last Updated: February 6, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: We will share results after 6 months from publication.

Locations

EG (1)