NCT04663256

Brief Summary

Mild cognitive impairment is becoming one of the most common cynical manifestations that affect older people. That is why there is a need to investigate non-pharmacological interventions that help to improve or maintain this problem.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2020

Completed
25 days until next milestone

First Posted

Study publicly available on registry

December 10, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

January 11, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2021

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2021

Completed
Last Updated

May 26, 2022

Status Verified

May 1, 2022

Enrollment Period

3 months

First QC Date

November 15, 2020

Last Update Submit

May 20, 2022

Conditions

Outcome Measures

Primary Outcomes (4)

  • MMSE (mini-mental state examination)

    A tool that can be used to systematically and thoroughly assess mental status.

    Baseline-8 weeks

  • Yesavage Geriatric Depression Scale Adjetivo 1 relating to old people, especially with regard to their healthcare. a geriatric hospital Sustantivo 1 an old person, especially one receiving special care. a rest home for geriatrics.

    Hetero-administered questionnaire used to detect depression in people over 65 years of age.

    Baseline-8 weeks

  • Hamilton Scale for Anxiety.

    Hetero-administered scale used for the detection of anxiety, exploring the interruption of the emotional continum and subjective feelings of tension, restlessness or nervousness.

    Baseline-8 weeks

  • SF-36 (The Short Form-36 Health Survey)

    Used extensively for assessing health-related quality of life.

    Baseline-8 weeks

Study Arms (2)

Cognitive Stimulation Group

EXPERIMENTAL

This group receives physical training based on exercises for cognitive stimulation.

Other: Cognitive stimulation group

Control Group

NO INTERVENTION

This group does not receive any treatment.

Interventions

Each week for 12 weeks, GE participants attend three 60-minute sessions of cognitive exercises.

Cognitive Stimulation Group

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • With or without dependency to move.
  • People who show mild cognitive impairment.
  • That they were able to carry out the different selected questionnaires.

You may not qualify if:

  • People with visual deficit.
  • People already enrolled in a cognitive program.
  • Score between 24 and 10 in the Mini Cognitive Exam (MEC).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

U.E.D. Virgen de la Capilla

Jaén, 23330, Spain

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

November 15, 2020

First Posted

December 10, 2020

Study Start

January 11, 2021

Primary Completion

April 5, 2021

Study Completion

April 12, 2021

Last Updated

May 26, 2022

Record last verified: 2022-05

Locations