NCT07251452

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2025

Shorter than P25 for phase_1

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

September 1, 2025

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 26, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
Last Updated

April 28, 2026

Status Verified

December 1, 2025

Enrollment Period

14 days

First QC Date

November 17, 2025

Last Update Submit

April 27, 2026

Conditions

SleepGerontologyPhysical TherapyCognitive

Keywords

quality of lifesleepphysical activitycognitive intervention

Outcome Measures

Primary Outcomes (1)

  • Sleep

    Latency, sleep efficiency, number of awakenings during the night will be measured by actigraphy. The Pittsburgh Sleep Quality Index (PSQI) questionnaire will be used to asees objetive sleep quality and patterns in adults. It consists of 19 self-reported items. The 9 self-reported items of the PSQI generate seven component scores (with subscales ranging from 0 to 3): sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleep medication, and daytime dysfunction. The sum of these seven component scores produces an overall subjective sleep quality score (ranging from 0 to 21). Higher scores indicate poorer subjective sleep quality.

    Pre intervention T0 (one week before intervention started), post intervention T1 (after 12 weeks of intervention) and follow up T2 (8 weeks after the end of the intervention).

Secondary Outcomes (10)

  • Quality of life in older people

    Pre intervention T0 (one week before intervention started), post intervention T1 (after 12 weeks of intervention) and follow up T2 (8 weeks after the end of the intervention).

  • Cognitive assessment and training

    Pre intervention T0 (one week before intervention started), post intervention T1 (after 12 weeks of intervention) and follow up T2 (8 weeks after the end of the intervention).

  • Sociodemographic variables

    Pre intervention T0 (one week before intervention started), post intervention T1 (after 12 weeks of intervention) and follow up T2 (8 weeks after the end of the intervention).

  • Degree of independence of older people in performing Basic Activities of Daily Living (BADLs)

    Pre intervention T0 (one week before intervention started), post intervention T1 (after 12 weeks of intervention) and follow up T2 (8 weeks after the end of the intervention).

  • Functional capacity in Instrumental Activities of Daily Living

    Pre intervention T0 (one week before intervention started), post intervention T1 (after 12 weeks of intervention) and follow up T2 (8 weeks after the end of the intervention).

  • +5 more secondary outcomes

Study Arms (3)

Control

PLACEBO COMPARATOR

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

Behavioral: Control

Otago programme

EXPERIMENTAL

a physical activity intervention is applied to the participants.

Behavioral: Otago programme

Otago programme + Cognitift

EXPERIMENTAL

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

Behavioral: Otago programme + Cognifit

Interventions

Otago programmeBEHAVIORAL

Otago physical activity program adapted to elderly people

Otago programme
Otago programme + CognifitBEHAVIORAL

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

Otago programme + Cognitift
ControlBEHAVIORAL

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

Control

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • be under 65 years of age.
  • suffer from serious pathologies that prevent the intervention from being carried out.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Toledo, Toledo, 45005, Spain

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Predoctoral researcher

Study Record Dates

First Submitted

November 17, 2025

First Posted

November 26, 2025

Study Start

September 1, 2025

Primary Completion

September 15, 2025

Study Completion

February 28, 2026

Last Updated

April 28, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)