PNF and Frenkel's Exercises for Postmenopausal Women

February 10, 2020 updated by: Hilal Yeşil

The Effects of PNF and Frenkel's Exercises on Balance, Fall Risk, and Quality of Life in Postmenopausal Women

Postural stability is impaired due to the decrease in estrogen in the postmenopausal period, which may lead to disruption of balance and risk of falling. Our objective was to investigate the effects of PNF and Frenkel's exercises on balance, fall risk, and quality of life in postmenopausal women.

Methods: Forty-eight postmenopausal women were randomized into PNF (n = 24) (5 days a week) and Frenkel (n = 24) (5 days a week as a home exercise program) exercise groups. Hand grip strength, quality of life (short form- 36), falling risk (Falls Risk of Older People-Community Setting [FROP-COM]), and balance (functional reach test [FRT], one - leg stand test [OLST], timed up and go test [TUG], and Berg balance scale [BBS]) of all patients were evaluated prior to treatment, and at 4th week follow-up. The treatment responses were evaluated at the beginning, and at the 4th week.

Study Overview

Status

Completed

Detailed Description

In this study, we aimed to investigate the effects of PNF and Frenkel's exercises on balance, fall risk, and quality of life in postmenopausal women.

Methods: Forty-eight postmenopausal women were randomized into PNF (n = 24) (5 days a week) and Frenkel (n = 24) (5 days a week as a home exercise program) exercise groups. Hand grip strength, quality of life (short form- 36), falling risk (Falls Risk of Older People-Community Setting [FROP-COM]), and balance (functional reach test [FRT], one - leg stand test [OLST], timed up and go test [TUG], and Berg balance scale [BBS]) of all patients were evaluated prior to treatment, and at 4th week follow-up. The treatment responses were evaluated at the beginning, and at the 4th week. A total of 13 patients (27.1%) had a history of falls in the last 6 months and 12 months. According to the intra-group assessment; there was a significant improvement in all parameters in PNF group (p<0.05). In Frenkel group, there was a significant improvement in all evaluations except the OLST (p=0.064), and the short form-36 mental health score (p=0.057). Among the groups; no significant difference was detected in terms of hand grip strength, FROP-COM, FRT and TUG scores (p > 0.05). The OLST and BBS scores was significantly higher in the PNF group (p=0.022, and p= 0.002, respectively). To conclude, PNF and Frenkel exercise programs had significant effects on balance parameters, risk of falling and quality of life in postmenopausal women. Frenkel home exercise program is cheaper, easier, and requires less manpower, therefore, we think that it may be more preferable in terms of improving balance and reducing fall risk in postmenopausal women.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Eyalet/Yerleşke
      • Afyon, Eyalet/Yerleşke, Turkey, 0300
        • Hilal Yeşil

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

46 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

- Postmenopausal women aged between 50-80 years who can walk independently were included in the study

Exclusion Criteria:

  • 1. Having diabetic retinopathy and nephropathy, 2. The presence of plantar ulcers, 3. Presence of coronary artery disease, 4. Presence of peripheral vascular disease, 5. Presence of vision disorders, 6. Having a history of use of assistive walking device, 7. Presence of severe neurological, muscular or rheumatologic disease, 8. History of alcohol use, 9. Having lower limb amputation, 10. Presence of dementia, 11. Having a malignancy history, 12. Having a hearing problem, 13. Using a drug affecting balance, 14. Patients included in regular exercise program, and 15. Presence of neurological diseases affecting balance (stroke, multiple sclerosis, Parkinson's disease, epilepsy, etc.).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PNF exercise
In the PNF exercise group; exercises were performed in company with a physiotherapist 5 days a week (30 minutes ) for 4 weeks. Five specific techniques were applied to the patients: dynamic stabilization, rhythmic stabilization, combined isotonic contractions, and hold-relax active motion
Proprioceptive neuromuscular facilitation (PNF) is a form of neuromuscular retraining type containing the stimulation of sensory receptors to provide information about the body position and movement to facilitate the intended movement
Active Comparator: Frenkel exercise
In the Frenkel exercise group, Frenkel coordination exercises were given in home exercise program 5 days a week for 4 weeks.The physiotherapist demonstrated Frenkel exercises to them once.
The Frenkel exercises consist of a series of slow, repetitive movements performed in different positions while lying, sitting and standing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline Falls Risk for Older People-Community Setting (FROP-COM) score at 4 th week.
Time Frame: up to 4 weeks
FROP-COM); includes 13 fall risk factor sections. The sum of the individual scores provides a total fall risk score ranging between 0 and 60 and higher scores refer to higher risks. While scores between 0-20 are evaluated as low- moderate fall risk, those between 21-60 scores are evaluated as high fall risk
up to 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change from baseline Functional reach test score at 4 th week
Time Frame: up to 4 weeks
Functional reach test is a performance-based test measuring the maximum distance a person can reach while standing in a fixed position without losing balance, taking a step or touching a wall. The patients were asked to reach forward as far as possible without falling and stepping. The distance between the start and end positions was measured and recorded. Three trials were conducted and the average of the last two was noted .
up to 4 weeks
change from baseline one leg stand test score at 4 th week
Time Frame: up to 4 weeks
One leg stand test; as the starting position, the patients were asked to stand in a relaxed way with their eyes open with evenly distributed weight on both feet. The patients were then asked to stand freely on one leg for as long as possible. The test was terminated after 30 seconds or when the patient's foot touched to the ground. Then, the time was recorded
up to 4 weeks
change from baseline timed up and go test score at 4 th week
Time Frame: up to 4 weeks
Timed up and go test; the patient was asked to stand up while sitting in a chair, to walk to a line three meter away at a comfortable and safe speed and then return back and sit again on the chair. In this process, time was kept with stopwatch. In order to determine fall risk, a cut-off point of ≥13.5 seconds was used
up to 4 weeks
change from baseline berg balance scale score at 4 th week
Time Frame: up to 4 weeks
Berg balance scale (BBS) is a scale consisting of 14 items. Each of these items is scored between 0 and 4. "0" indicates that the task cannot be done. As the score goes to 4, the patient completes the task independently. Total score range is between 0 and 56. Here, while 0 point reflect the worst balance, 56 points refer to the best balance
up to 4 weeks
change from baseline hand grip strength test score at 4 th week
Time Frame: up to 4 weeks
Hand grip strength test; was evaluated with JAMAR dynamometer (BASELINE hydraulic hand dynamometer FEI White Plains, NY 10602 USA). The patients were asked to sit flat, hold their upper arm in a neutral position and keep their elbows at 90° flexion. The forearm was held in a neutral position and they were asked to hold their elbow in extension between 0 and 30°. The patient was then asked to grip the device with all of his/her strength.
up to 4 weeks
change from baseline short form 36 score at 4 th week
Time Frame: up to 4 weeks
Short form (SF)- 36; is a generic scale frequently used to assess quality of life. SF-36 is composed of 36 items used in the calculation of 8 different scale scores and consists of the following eight subscales. While 0 point indicates the worst health status, 100 points signify best health status.
up to 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2018

Primary Completion (Actual)

August 30, 2019

Study Completion (Actual)

August 30, 2019

Study Registration Dates

First Submitted

February 10, 2020

First Submitted That Met QC Criteria

February 10, 2020

First Posted (Actual)

February 12, 2020

Study Record Updates

Last Update Posted (Actual)

February 12, 2020

Last Update Submitted That Met QC Criteria

February 10, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • HYSS2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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