Nurse-Led Elderly Sleep Intervention

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.

Study Overview

• Status: Completed
• Conditions: Sleep; Physical Therapy; Gerontology; Cognitive
• Intervention / Treatment: Behavioral: Control; Behavioral: Otago programme; Behavioral: Otago programme + Cognifit

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.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Spain
  • Toledo
    • Toledo, Toledo, Spain, 45005
      • Faculty of Physiotherapy and Nursing, Arms Factory, Toledo, 45071 Spain

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control; Talks are given on health education topics that are not related to the intervention to the participants.	Behavioral: Control; Talks about topics of interest in health sciences not related to sleep
Experimental: Otago programme; a physical activity intervention is applied to the participants.	Behavioral: Otago programme; Otago physical activity program adapted to elderly people
Experimental: Otago programme + Cognitift; a physical activity and cognitive training intervention is applied to the participants.	Behavioral: Otago programme + Cognifit; Otago physical activity program adapted for seniors and cognitive training with the Cognifit app for smartphones or tablets.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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."	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	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.	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	Questionnaire on sociodemographic variables of own elaboration will be used for the collection of sociodemographic, anthropometric and health and drug-related data.	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)	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.	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	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).	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).
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.	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).
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.	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).
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.	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.
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.	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 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.	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.

Collaborators and Investigators

• Sponsor: University of Castilla-La Mancha

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2025
• Primary Completion (Actual): September 15, 2025
• Study Completion (Actual): February 28, 2026

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 24, 2025
• First Posted (Actual): November 26, 2025

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: physical activity; sleep; quality of life; cognitive intervention
• Additional Relevant MeSH Terms: Behavior; Motor Activity
• Other Study ID Numbers: Gerontology-sleep

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No