NCT05342142

Brief Summary

The aim of this study is to investigate the effects of aerobic and resistance exercises on depression, alexithymia levels and quality of life of elderly individuals.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
unknown

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

February 23, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 12, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 22, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

April 22, 2022

Status Verified

April 1, 2022

Enrollment Period

4 months

First QC Date

April 12, 2022

Last Update Submit

April 18, 2022

Conditions

Keywords

DepressionAlexithymiaQuality of LifeElderlyExercise

Outcome Measures

Primary Outcomes (3)

  • Depression

    depression level as measured by the geriatric depression scale (min:0, max:15, 5 or more means more depression)

    1 week

  • Alexythimia

    Alexythimia level as measured by the toronto Alexythimia scale (min:0, max:100, 61 ore more means more alexythimia)

    1 week

  • quality of life

    level of quality of life measured by health related quality of life scale(min:24, max:120, high levels means low quality of life)

    1 week

Study Arms (2)

Exercise

ACTIVE COMPARATOR

Exercise program consisting of 12 weeks of aerobic and resistance exercises

Behavioral: Aerobic and ResistanceExercise

Control

NO INTERVENTION

No intervention will be made

Interventions

Exercise program consisting of 12 weeks of aerobic and resistance exercises

Exercise

Eligibility Criteria

Age65 Years+
Sexall(Gender-based eligibility)
Gender Eligibility Details65 years and over
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Individuals aged 65 and over who volunteered to participate in the study,
  • Conscious and without communication problems,
  • No orthopedic injury that prevents walking
  • Those who are physically inactive according to the International Physical Activity Assessment Questionnaire
  • Those who have sufficient motivation to participate in the exercise program (will be evaluated by a one-on-one interview by the researchers)
  • Being eligible to participate in an exercise program after a cardiac examination (resting ECG and questioning of cardiac symptoms, advanced tests such as exercise ECG test if necessary) performed by the physician.

You may not qualify if:

  • Having a history of neuromuscular disease
  • Serious medical condition (eg advanced malignancy or major neurological, psychiatric or endocrine disease, respiratory failure, etc.) that would prevent the person from participating in exercise training.
  • Less than 1 year life expectancy
  • Having an orthopedic injury that prevents walking
  • Presence of advanced sensory deficit
  • Having visual and hearing problems
  • Not having sufficient communication skills (Mini Mental Test score below 24 points)
  • Not having agreed to participate in the study
  • Uncontrolled hypertension
  • Not being found suitable for exercise in the examination performed by physicians and physiotherapists

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sultan Abdülhamid Training and Research Hospital

Istanbul, Uskudar, 34366, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

DepressionAffective SymptomsSedentary BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Elif Yıldırım Ayaz, M.D.

    Sultan Abdülhamid Training And Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elif Yıldırım Ayaz, M.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2022

First Posted

April 22, 2022

Study Start

February 23, 2022

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

April 22, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations