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SleepPhase 1/2NCT07251452

Nurse-Led Elderly Sleep Intervention

A Phase 1/2 study testing Otago programme and Otago programme + Cognifit in people with Sleep and Gerontology, run by University of Castilla-La Mancha at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Sleep, Gerontology, Physical Therapy
What is being tested?
Otago programme and Otago programme + Cognifit
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
66 participants
Where
1 siteSpain
Study dates
1 Sep 2025to 28 Feb 2026
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Faculty of Physiotherapy and Nursing, Arms Factory, Toledo, 45071 Spain

    Toledo, Toledo, 45005

Other trials in Spain

About this study

Official title: Efficacy of a Nurse-developed Physical and Cognitive Program to Improve Sleep and Quality of Life in Elderly: Randomized Clinical Trial

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.

Read the detailed description

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.

Being tested
Otago programme, Otago programme + Cognifit, Control
Keywords
quality of life, sleep, physical activity, cognitive intervention
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Otago programmeBehavioural

    Otago physical activity program adapted to elderly people

  • Otago programme + CognifitBehavioural

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

  • ControlBehavioural

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

Study groups in NCT07251452
Study groupRoleWhat they receive
ControlPlacebo comparatorTalks are given on health education topics that are not related to the intervention to the participants.
Receives: Behavioral: Control
Otago programmeExperimentala physical activity intervention is applied to the participants.
Receives: Behavioral: Otago programme
Otago programme + CognitiftExperimentala physical activity and cognitive training intervention is applied to the participants.
Receives: Behavioral: Otago programme + Cognifit

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)
  1. Quality of life in older people

    European Quality of Life 5 Dimensions (EQ-5D) will be used. Maximum score: 100, representing "best possible health." Minimum score: 0, representing "worst possible health."

    Measured: 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).

  2. Cognitive assessment and training

    The CogniFit® computerized battery for smart devices is used for neurocognitive assessment and training of various cognitive functions, such as memory, attention, planning, processing speed, and cognitive flexibility. The CogniFit® neurocognitive assessment uses a series of interactive tasks and exercises to measure the status of different cognitive domains, providing detailed quantitative and graphical results that allow for the identification of strengths and areas for improvement. It has been previously validated in older adults, demonstrating good internal consistency (Cronbach's alpha = 0.85-0.88) and test-retest reliability (r = 0.69-0.92). The neurological assessment provides an overall score expressed in normative scores compared to similar populations, facilitating its interpretation in both clinical and research contexts. In addition, it offers cognitive training exercises.

    Measured: 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).

  3. Sociodemographic variables

    Questionnaire on sociodemographic variables of own elaboration will be used for the collection of sociodemographic, anthropometric and health and drug-related data.

    Measured: 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).

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

    The Katz Index, will be used to assess the level of independence of older adults in performing Basic Activities of Daily Living (BADLs). This instrument measures functional capacity in essential daily living tasks, providing an objective view of the level of dependence or autonomy of the person being evaluated. The index assesses six basic functions: bathing, dressing, toileting, mobility, continence, and feeding. (6) points: Independent in all activities. (0) points: Dependent in all activities.

    Measured: 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. Functional capacity in Instrumental Activities of Daily Living

    The Lawton and Brody scale will be used to assess functional capacity in Instrumental Activities of Daily Living (IADLs), which are more complex tasks than basic activities and require more advanced cognitive and physical skills.

    0 points: Total dependence. 8 points: Total independence (for women, and 5 for men).

    Measured: 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).

  6. Level of social support and social network of older adults

    The Lubben Social Network Scale (LSCS) will be used to assess the level of social support and social network of older adults. It consists of six items scored on a 0-to-5 Likert scale. Higher scores reflect larger social networks and greater availability of social support. Conversely, scores below indicate a high risk of social isolation.

    Measured: 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).

  7. Depression

    Yesavage Geriatric Depression Scale will be used. Consists of 15 dichotomous (yes/no) questions, in which each item is scored 0 or 1 depending on the response.

    0-5 points: Normal. 6-9 points: Mild depression. > 10 points: Established depression.

    Measured: 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).

  8. Mobility

    The Timed Up and Go (TUG) test will be used to assess balance, mobility, and fall risk in older adults. The test involves recording the time it takes a person to perform the following tasks: stand up from a chair with armrests, walk a distance of 3 meters marked on the floor, turn around, return to the chair, and sit down again. The total time is measured in seconds using a stopwatch. According to the standards, a time of less than 10 seconds indicates excellent mobility, while times greater than 20 seconds suggest limited mobility and a higher risk of falls.

    Measured: 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.

  9. Memory

    The Memory Failures of Everyday (MFE) questionnaire will be used to assess everyday memory lapses. It consists of 28 items and is answered using a three-point Likert scale (Montejo et al. version) ranging from 'never in the last three months' to 'more than once a day'. Lower scores indicate fewer lapses, while higher scores indicate more lapses.

    Measured: 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.

  10. Cognitive disorders

    Lobo Mini-Mental State Examination (36-item version) will be used to assess cognitive impairment associated with neurodegenerative diseases. It consists of several items that evaluate five cognitive domains: memory, orientation, attention span, calculation, concentration, and language. In geriatric patients over 65 years of age, scores below 23 are considered indicative of cognitive impairment; in patients under 65 years of age, scores of 27 or below are considered indicative of cognitive impairment.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Nov 2025
  2. Study start1 Sep 2025
  3. Primary completion15 Sep 2025
  4. Study completion28 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07251452
Sponsor's protocol ID
Gerontology-sleep
Status last verified
Dec 2025
First submitted
17 Nov 2025
Last updated
22 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Otago programme and Otago programme + Cognifit in people with Sleep and Gerontology, run by University of Castilla-La Mancha at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sleep (time frame: 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).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.

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