NCT04266067

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 12, 2020

Completed
Last Updated

February 12, 2020

Status Verified

February 1, 2020

Enrollment Period

1.1 years

First QC Date

February 10, 2020

Last Update Submit

February 10, 2020

Conditions

Keywords

PNF exerciseFrenkel exercise

Outcome Measures

Primary Outcomes (1)

  • Change from baseline Falls Risk for Older People-Community Setting (FROP-COM) score at 4 th week.

    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 Outcomes (6)

  • change from baseline Functional reach test score at 4 th week

    up to 4 weeks

  • change from baseline one leg stand test score at 4 th week

    up to 4 weeks

  • change from baseline timed up and go test score at 4 th week

    up to 4 weeks

  • change from baseline berg balance scale score at 4 th week

    up to 4 weeks

  • change from baseline hand grip strength test score at 4 th week

    up to 4 weeks

  • +1 more secondary outcomes

Study Arms (2)

PNF exercise

ACTIVE COMPARATOR

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

Other: PNF exercise

Frenkel exercise

ACTIVE COMPARATOR

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.

Other: Frenkel exercise

Interventions

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

PNF exercise

The Frenkel exercises consist of a series of slow, repetitive movements performed in different positions while lying, sitting and standing.

Frenkel exercise

Eligibility Criteria

Age50 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \. 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.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hilal Yesil

Afyonkarahisar, Eyalet/Yerleşke, 0300, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Muscle Stretching Exercises

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

February 10, 2020

First Posted

February 12, 2020

Study Start

August 1, 2018

Primary Completion

August 30, 2019

Study Completion

August 30, 2019

Last Updated

February 12, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations