Effectiveness of a Dual Program for Improving Sleep in Older Adults.

NCT ID: NCT07251452

Last Updated: 2025-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-01

Study Completion Date

2026-02-28

Brief Summary

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The present clinical trial aims to test whether a dual program of physical activity and cognitive training improves sleep and quality of life in people over 65 years of age.

Detailed Description

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The intervention is being carried out in different day centers and co-housing centers in Toledo, Spain, where participants were recruited. A three-arm study was also conducted: a control group that received talks on health topics; a physical activity intervention group that followed the Otago physical activity program, tailored to; and a physical activity and cognitive training intervention group that used a mobile app known as Cognifit to develop the cognitive intervention.

Conditions

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Sleep Gerontology Physical Therapy Cognitive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Control

Talks are given on health education topics that are not related to the intervention to the participants.

Group Type PLACEBO_COMPARATOR

Control

Intervention Type BEHAVIORAL

Talks about topics of interest in health sciences not related to sleep

Otago programme

a physical activity intervention is applied to the participants.

Group Type EXPERIMENTAL

Otago programme

Intervention Type BEHAVIORAL

Otago physical activity program adapted to elderly people

Otago programme + Cognitift

a physical activity and cognitive training intervention is applied to the participants.

Group Type EXPERIMENTAL

Otago programme + Cognifit

Intervention Type BEHAVIORAL

Otago physical activity program adapted for seniors and cognitive training with the Cognifit app for smartphones or tablets.

Interventions

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Otago programme

Otago physical activity program adapted to elderly people

Intervention Type BEHAVIORAL

Otago programme + Cognifit

Otago physical activity program adapted for seniors and cognitive training with the Cognifit app for smartphones or tablets.

Intervention Type BEHAVIORAL

Control

Talks about topics of interest in health sciences not related to sleep

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* know how to use smartphones.
* have the ability to perform physical activity.

Exclusion Criteria

* be under 65 years of age.
* suffer from serious pathologies that prevent the intervention from being carried out.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Castilla-La Mancha

OTHER

Sponsor Role lead

Responsible Party

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Laura Pilar de Paz Montón

Predoctoral researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Physiotherapy and Nursing, Arms Factory, Toledo, 45071 Spain

Toledo, Toledo, Spain

Site Status

Countries

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Spain

Other Identifiers

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Gerontology-sleep

Identifier Type: -

Identifier Source: org_study_id

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