NCT04338230

Brief Summary

Changes and limitations in the aging process affect adaptation to old age. It is important for women to adapt to the problems of old age, find a solution and cope. This study was aimed to determine the effect of progressive muscle relaxation exercises on the level of depression and adaptation to old women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2019

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 30, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 8, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

February 17, 2021

Status Verified

February 1, 2021

Enrollment Period

6 months

First QC Date

April 4, 2020

Last Update Submit

February 15, 2021

Conditions

Keywords

Relaxation exercisesElderlyWomenAdaptation to old age

Outcome Measures

Primary Outcomes (1)

  • Standardized Mini Mental Test (SMMT)

    SMMT evaluates cognitive status. Women with a SMMT score 23 and above (min.0 - max. 30) were included in the study.

    Pretest of study

Secondary Outcomes (2)

  • Geriatric Depression Scale-Short Form (GDS-SF)

    2 month

  • Assessment Scale of Adaptation Difficulty for the Elderly

    2 month

Study Arms (2)

Experimental: Experimental group

EXPERIMENTAL

Women aged 65 and over (the standardized Mini-Mental State Examination (MMSE) test cognitive levels score of 23 and above points). Progressive muscle relaxation exercises are applied to the intervention group as 30-minute sessions three times a week for eight weeks.

Other: Progressive muscle relaxation exercise

No Intervention: Control group

NO INTERVENTION

Women aged 65 and over (the standardized Mini-Mental State Examination (MMSE) test cognitive levels score of 23 and above points).

Interventions

"Relaxation Exercises CD Audio Records" prepared by Turkish Psychological Association is used. Before starting the PMR exercises, the woman in the intervention group is provided to lie on a comfortable seat or bed, stretching the muscles of the face and all body for about 10 seconds starting from the hands to the foot in line with the sound recordings of the PKG exercises and then holding the deep breath while each muscle group is stretching, It is applied as a slow release of this breath during relaxation. In this way, the muscle groups in the hands, arms, neck, shoulders, chest, abdomen, hips, feet and fingers, the face and the whole body are tensioned and relaxed, and the woman is relaxed. During the eight-week period, the women are called by the researcher once a week and the exercises are reminded. Home visit There are 2 home visits at week 1 and at week 8. In case of need, repeated home visits are provided to ensure the continuity of the application.

Experimental: Experimental group

Eligibility Criteria

Age65 Years - 100 Years
Sexfemale
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • years and above,
  • Do not have a diagnosis of dementia and psychiatric disease by the doctor and have a mini-mental test score of 23 and above,
  • Being independent in practicing daily living activities
  • There is no problem with communication

You may not qualify if:

  • Under the age of 65
  • Being addicted in daily life activities
  • Being diagnosed with dementia and psychiatric illness
  • Mini-mental test score below 23

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aksaray University

Aksaray, 68000, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: A Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Assistant Professor

Study Record Dates

First Submitted

April 4, 2020

First Posted

April 8, 2020

Study Start

December 30, 2019

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

February 17, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations