Effectiveness of PNF Training for Improving for Muscle Strength, Function, and Pain After Axillary Lymph Node Dissection

NCT05288036 | Completed

• 1 other identifier: 10840098-604.01.01-E.184
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Breast cancer is the most common type of cancer affecting women of all ages worldwide. Advanced and comprehensive treatment options have increased survival rate and life expectancy, necessitating a focus on the complications of breast cancer treatment. Although axillary lymph node dissection (ALND) causes high morbidity, it is an integral part of surgical treatment in patients with invasive breast cancer and axillary lymph node metastasis. Axillary lymph node dissection and radiotherapy are associated with pain, physical symptoms, and decreased functional abilities in the upper extremity. This study aimed to compare the potential effects of proprioceptive neuromuscular facilitation (PNF) technique on muscle strength, pain and functionality in this patient group with progressive resistance exercise (PRT).

Conditions

Breast Cancer; Muscle Strength

Keywords

Proprioceptive Neuromuscular Facilitation; Pain; Axillary Disease

Outcome Measures

Primary Outcomes (4)

• Isokinetic dynamometer

  Humac Norm, model 770, Computer Sports Medicine Inc., Stoughton, USA was used to biomechanically evaluate shoulder flexors/extensors, abductor/adductors, internal/external rotators. Muscle strength was measured at 60°/s, muscle strength at 120°/s, endurance at 180°/s angular velocity and in concentric/concentric mode. 5 repetitions at 60°/s and 120°/s angular velocity, and 15 repetitions at 180°/s angular velocity were performed at the measured active range of motion. The measurement was performed only on the operated side upper extremity. A rest period of 2 minutes was provided between series of each muscle group and 5 rest periods between different movement patterns. For each angular velocity, the first trial was subtracted, and the average peak torque value of the remaining repetitions (the force produced by the individuals at the maximum during the angular velocity) was recorded in Newton-meters (Nm).

  "8 weeks"."Two measurements were made to evaluate the change before treatment (baseline) and at the end of treatment (8 weeks later).".

• Disabilities of the Arm, Shoulder, and Hand (DASH)

  The scale includes 30 questions about symptoms (5 items) and functionality (25 items). In this study, business/sport-specific additional modules of the scale were not used. Each item offers 5 answer options and is scored on a likert scale from 1 to 5. 1: reflects 'no difficulty' and 5: reflects 'serious difficulties'. The resulting scores for all items are then used to calculate the total score from 0 (no disability) to 100 (most severe disability) (16). It is accepted as the most consistent test in terms of construct validity and responsiveness in examining upper extremity problems in individuals undergoing breast cancer treatment.

  "8 weeks"."Two measurements were made to evaluate the change before treatment (baseline) and at the end of treatment (8 weeks later).".

• Visual Analogue Scale (VAS)

  The patients were asked to mark their pain levels in the breast, shoulder and axilla regions on the affected side during rest and activities of daily living on a 10 cm scale (0=no pain, 10=worst pain ever experienced). The distance (cm) between the zero point and the point marked by the patient indicates the level of pain.

  "8 weeks". "Two measurements were made to evaluate the change before treatment (baseline) and at the end of treatment (8 weeks later).".

• Global Rating Of Change Scale (GRC)

  The Global Rating of Change Scale (GRC) contains a single question in which the patient can rate how much he has improved retrospectively from his own perspective. The validity and reliability of the GRC scale has been verified and is widely used in the assessment of change for musculoskeletal problems. 7 different answers (-3: much worse, 2: worse, -1: slightly worse, 0: the same, 1: a little better, 2: quite good, 3 They were asked to answer by choosing one of the :much better) options. In scoring, scoring can be done according to a 7-point Likert evaluation, as well as calculations can be made using negative scores. This scale was applied only to the study groups in the post-treatment measurement.

  "8 weeks". "Baseline and 8th week".

Study Arms (3)

Proprioceptive Neuromuscular Rehabilitation group

EXPERIMENTAL

PNF techniques; It is based on facilitating the responses of neuromuscular mechanisms by stimulating proprioceptors. It is a method used to improve active movement ability by increasing muscle strength, to increase muscle endurance, to improve stabilization at the point where the technique is applied within the movement pattern.

Other: Proprioceptive Neuromuscular Rehabilitation group

Progressive Resistance Exercise Group

EXPERIMENTAL

Progressive resistance training (PRT) is a method for increasing muscle strength and endurance based on the determination of the amount of resistance appropriate for the individual. Free weights and resistance machines are used in the practice of this technique.To facilitate continued adaptation, training intensity (i.e. load) and training volume (i.e. number of sets) are progressively increased, and exercises are adjusted as indicated throughout the training regimen, to attenuate the onset of a plateau in physiological adaptation.

Other: Progressive Resistance Exercise Group

Control Group

ACTIVE COMPARATOR

This group was created to determine the amount of self-healing of the disease in the process. The approach was taken in a way that did not affect the outcome measures.

Other: Control Group

Interventions

Proprioceptive Neuromuscular Rehabilitation group OTHER

The PNF technique was performed in the supine position with the hip joints of the patients in 30° flexion and the lower extremities in semi-flexion. The application was performed in 2 different diagonal and 4 different patterns (flexion-abduction-external rotation/extension-abduction-internal rotation, and flexion-adduction-external rotation/extension-abduction-internal rotation) of the upper extremity. When starting the exercise, the muscles were first brought to their longest position and the patient was asked to move in the direction of the pattern with resistance (concentric contraction) and to maintain this position for 6 seconds at the end of the pattern (isometric contraction). Then, while the therapist was taking the patient's arm to the starting position, the patient was asked to prevent movement (eccentric contraction). All of these moves counted as one repetition. 3 sets of 8-12 repetitions were performed for each pattern.

Also known as: PNF

Proprioceptive Neuromuscular Rehabilitation group

Progressive Resistance Exercise Group OTHER

Strengthening exercises targeting the upper extremity main muscles were applied to the PRE group with progressive resistance. Dumbbells and sandbags were used as resistance equipment. resistance intensity; 50-80% of a repetition maximum (RM) was determined according to the patient's tolerance. The exercises were applied as 8-12 repetitions and 3 sets. A rest period of 60-90 seconds was allowed between each set. After the 4th week of the training, 1 RM was measured again and the resistance density was updated. The 8 strengthening exercises to be applied were created by taking examples from the literature and in accordance with the "Guidelines for implementing exercise programs exercise programs for cancer patients". These exercises are: "dumbbell fly", "triceps extension", "biceps curl up", "one-arm bent over row", "dumbbell sides rise", "lifting the arm forward", "wrist curl" and side lying shoulder internal -external rotation".

Also known as: PRE

Progressive Resistance Exercise Group

Control Group OTHER

The patients in the control group were instructed to continue their usual daily lives (not changing their physical activity levels, diet, drug use, etc.) until the date of re-evaluation after the initial evaluation. Information was given about the upper extremity normal range of motion exercises that they could apply at home, and a brochure was given.

Control Group

Eligibility Criteria

• Age: 30 Years - 65 Years
• Gender Eligibility Details: Only female patients were included in the study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals diagnosed with stage II-III breast cancer
• years old
• ALND was performed by the same surgeon regardless of breast resection level.
• Receiving radiotherapy
• Individuals who spent the first six months after surgery were included in the study.

You may not qualify if:

• Diagnosed with stage IV or metastatic breast cancer
• Developing bilateral breast cancer
• Developing lymphedema in the postoperative period
• Any contraindication to exercise
• Participating in any physiotherapy program for the upper extremity in the last 6 months
• Have significant cardiac, pulmonary or metabolic comorbid disease
• Individuals with communication problems were excluded from the study.

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Medipol Mega University Hospital

Istanbul, 34214, Turkey (Türkiye)

Location

Related Publications (5)

• Hindle KB, Whitcomb TJ, Briggs WO, Hong J. Proprioceptive Neuromuscular Facilitation (PNF): Its Mechanisms and Effects on Range of Motion and Muscular Function. J Hum Kinet. 2012 Mar;31:105-13. doi: 10.2478/v10078-012-0011-y. Epub 2012 Apr 3.

  PMID: 23487249 BACKGROUND

• da Silveira DSP, Dos Santos MJ, da Silva ET, Sarri AJ, das Neves LMS, Guirro ECO. Proprioceptive neuromuscular facilitation in the functionality and lymphatic circulation of the upper limb of women undergoing breast cancer treatment. Clin Biomech (Bristol). 2020 Dec;80:105158. doi: 10.1016/j.clinbiomech.2020.105158. Epub 2020 Aug 31.

  PMID: 32896753 BACKGROUND

• Kraemer WJ, Ratamess NA. Fundamentals of resistance training: progression and exercise prescription. Med Sci Sports Exerc. 2004 Apr;36(4):674-88. doi: 10.1249/01.mss.0000121945.36635.61.

  PMID: 15064596 BACKGROUND

• Cormie P, Singh B, Hayes S, Peake JM, Galvao DA, Taaffe DR, Spry N, Nosaka K, Cornish B, Schmitz KH, Newton RU. Acute Inflammatory Response to Low-, Moderate-, and High-Load Resistance Exercise in Women With Breast Cancer-Related Lymphedema. Integr Cancer Ther. 2016 Sep;15(3):308-17. doi: 10.1177/1534735415617283. Epub 2015 Nov 17.

  PMID: 26582633 BACKGROUND

• Guloglu S, Basim P, Algun ZC. Efficacy of proprioceptive neuromuscular facilitation in improving shoulder biomechanical parameters, functionality, and pain after axillary lymph node dissection for breast cancer: A randomized controlled study. Complement Ther Clin Pract. 2023 Feb;50:101692. doi: 10.1016/j.ctcp.2022.101692. Epub 2022 Nov 11.

  PMID: 36528984 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Pain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Pelin Basim, Assoc. prof.

  Medipol University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2021
• First Posted: March 18, 2022
• Study Start: December 12, 2019
• Primary Completion: June 15, 2021
• Study Completion: July 1, 2021
• Last Updated: March 18, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)