Clinical trial NCT03757806: Lifestyle Integrated Functional Exercise for People With Dementia: a Home-based Physical Activity Program
Official title: LiFE4D: a Home-based Physical Activity Program for Community-dwelling People With Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: Dementia
Physical activity
Home-based
Lifestyle
Lead sponsor: Aveiro University
Sponsor class: OTHER
Collaborators: name: School of Health, Polytechnic Institute of Setúbal (ESS/IPS)
First posted: 2018-11-29
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled trial will be conducted. Participants will be randomized to the control group or intervention group.

The control group will receive usual care only (e.g., pharmacologic treatment), whilst the experimental group will receive an individualized home-based physical activity program at home (LiFE4D) in addition to usual care.
Primary purpose: TREATMENT

Brief summary: Physical activity improves cognitive function and the ability to perform activities of daily living in people with dementia and reduces caregivers' burden thus, enhancing quality of life of people with dementia and their caregivers. The wish of most people with dementia, and their caregivers, is to live at their home, for as long as possible. However community-dwelling people with dementia have low levels of physical activity, increasing dependency, which often leads to institutionalization. The Lifestyle Integrated Functional Exercise (LiFE) program has been shown to decrease sedentary activity time and dependency in activities of daily living of older people, however, it has never been implemented in people with dementia. LiFE might be promising as it focuses on establishing new behaviors within selected contexts to stimulate physical activity at home. Therefore, a home-based physical activity program, based on LiFE and involving caregivers, LiFE4D, will be implemented and evaluated in community-dwelling people with dementia.

Detailed description: Sustaining levels of regular physical activity of people with dementia is essential to maintain independence on activities of daily living, increase health-related quality of life and delay the need for institutionalization. Home-based physical activity programs, involving the caregivers, may overcome the drawbacks of the low adherence and high dropout rates by including physical activity in daily routines of people with dementia, thus increasing their motivation and confidence levels. LiFE is a home-based physical activity program which embeds training into patients' daily routines. It has shown to be well accepted and effective in healthy older people, however its effectiveness in people with dementia remains unknown.

Therefore, the primary aim of this study is to assess the impact of a home-based physical activity program, based on the LiFE program and involving the caregivers (LiFE4D), on exercise tolerance of community-dwelling people with dementia, using a randomized controlled design. The secondary aims are to:

* establish the feasibility of LiFE4D and adherence to the intervention;
* explore the impact of the LiFE4D on other health-related physical fitness components, (i.e., neuromotor, muscular strength, flexibility and body composition); physical activity, health-related quality of life, social networks and informal care time provision;
* assess the cost-effectiveness of the LiFE4D on the number of falls, healthcare resources utilization, length of hospital stay and number of respiratory infections.

To accomplish these aims, a pilot (task 1) and a randomized controlled study (task 2) will be conducted. LiFE4D will be centered on the duo participant/caregiver capacities and potentialities and it will be a significant contribution towards the development and implementation of an innovative home-based physical activity intervention. Additionally, it will inform the cost-effectiveness of this intervention in people with dementia. Ultimately, findings from this project will provide guidance to national and international health policies on physical activity promotion in community-dwelling people with dementia.

Task 1: LiFE4D - Pilot study

A pilot study will inform sample size, recruitment/randomization procedures and feasibility of LiFE4D.

Ethical approval will be obtained from Ethics and Data Protection Committees. People with dementia will be included if they: have a diagnosis of mild/moderate dementia according to Diagnostic and Statistical Manual of Mental Disorders (DSM-V); are living at home; are not participating in exercise training; are able to follow instructions and have a caregiver. People with dementia will be excluded if they: have been hospitalized in the previous month; present any clinical condition that precludes them to be involved in physical activity; have been taking medication that affect exercise capacity/bone density. Eligible participants will be identified via care homes, day care centers and Alzheimer Cafes (meetings with people with dementia and families). These institutions will contact eligible participants. Informed consent will be obtained from interested people with dementia and legal representatives.

The Experimental Group (EG) will receive the LiFE4D in addition to usual care (e.g., pharmacologic treatment), whilst the Control Group (CG) will receive usual care only.

Protocol will take approximately 1h and data will be collected at participants' home at baseline and after 12 weeks. ActiGraph will be used during one week before and one week after the 12 weeks. Participants will wear the ActiGraph for at least 6 consecutive days. Additionally, at baseline the EG group will be assessed (with observation and a structured questionnaire) on their daily routines to adjust the intervention to each participant's needs.

Feasibility measures. Adherence to LiFE4D and number/reasons of dropouts will be collected.

Intervention LiFE4D information will be offered during a collective session for the EG, i.e., people with dementia and their caregivers. Then, the individualized program will be set up, adapted to the participant's needs/preferences.

People with dementia will train balance, flexibility, endurance and strength multiple times/day in their everyday tasks with the support/supervision of their caregivers. Strategies to improve balance include "reduce base of support" (e.g., working at the kitchen while standing on one leg), "move to limits of sway", "shift weight from foot to foot", "step over objects" and "turning and changing direction". Strategies to increase strength and endurance include "bend your knees" (e.g., squatting instead of bending at the waist to close a drawer or to picking things up from the floor), "on your toes", "up the stairs", "on your heels", "sit to stand", "walk sideways" and "tighten muscles". Intensity of training will be adjusted throughout the program based on the regular evaluation of balance and strength.

The program will last for 12 weeks, with a lower face tracking over time with the health professional but replaced by involvement of caregivers. Specifically includes:

* Weeks 1-4: 3 face-to-face sessions/week;
* Weeks 5-8: 2 face-to-face sessions/week and a biweekly phone call;
* Weeks 9-11: 1 face-to-face session/week and a phone call;
* Week 12: 1 phone call. Face-to-face sessions aim to adapt physical activity to everyday tasks, increase tasks frequency and/or intensity, monitor progress, clarify doubts, motivate higher daily energy expenditure and manage expectations. Telephone contacts aim to monitor people with dementia's motivation/evolution and clarify doubts of people with dementia and caregivers.

Task 2: Implementation and evaluation of LiFE4D

Informed by task 1, a powered (80%, alpha=0.05) randomized controlled trial will be designed.

Data collection times: as described in task 1, however, additional assessments for follow up will be conducted at 3, 6 months after the LiFE4D, to assess short- and long-term results.

Eligibility criteria: Inclusion Criteria:

* have a diagnosis of mild/moderate dementia according to Diagnostic and Statistical Manual of Mental Disorders (DSM-V); are living at home; are not participating in exercise training; are able to follow instructions and have a caregiver.

Exclusion Criteria:

* have been hospitalized in the previous month; present any clinical condition that precludes them to be involved in physical activity; have been taking medication that affect exercise capacity/bone density.

Primary outcomes:
measure: 2 Minute Step test - change in exercise tolerance
timeFrame: Assessment at baseline, post (3 months) and 3 months and 6 months follow-up for experimental and control groups.
Secondary outcomes:
measure: Addenbrooke's Cognitive Examination III - change in cognitive function
timeFrame: Assessment at baseline, post (3 months) and 3 months and 6 months follow-up for experimental and control groups.
measure: Brief Balance Evaluation System Test - change in balance
timeFrame: Assessment at baseline, post (3 months) and 3 months and 6 months follow-up for experimental and control groups.
measure: Brief Physical Activity Assessment tool - change in self-reported physical activity
timeFrame: Assessment at baseline, post (3 months) and 3 months and 6 months follow-up for experimental and control groups.
measure: Accelerometer-based activity monitors - change in physical activity levels
timeFrame: Assessment at baseline, post (3 months) and 3 months and 6 months follow-up for experimental and control groups.
measure: Handgrip Dynamometer - change in maximum isometric strength of the hand and forearm muscles
timeFrame: Assessment at baseline, post (3 months) and 3 months and 6 months follow-up for experimental and control groups.
measure: 30 second sit to stand test - change in lower limb strength
timeFrame: Assessment at baseline, post (3 months) and 3 months and 6 months follow-up for experimental and control groups.
measure: Grocery Shelving Task - change in upper limb functionality
timeFrame: Assessment at baseline, post (3 months) and 3 months and 6 months follow-up for experimental and control groups.
measure: Chair sit and reach test - change in flexibility
timeFrame: Assessment at baseline, post (3 months) and 3 months and 6 months follow-up for experimental and control groups.
measure: Functional Reach Test - change in functionality
timeFrame: Assessment at baseline, post (3 months) and 3 months and 6 months follow-up for experimental and control groups.
measure: Timed Up and Go test - change in functional mobility
timeFrame: Assessment at baseline, post (3 months) and 3 months and 6 months follow-up for experimental and control groups.
measure: Physical Performance Test - change in overall functionality
timeFrame: Assessment at baseline, post (3 months) and 3 months and 6 months follow-up for experimental and control groups.
measure: Peak Flow Meter - change in lung function
timeFrame: Assessment at baseline, post (3 months) and 3 months and 6 months follow-up for experimental and control groups.
measure: Maximal inspiratory (MIP) and expiratory (MEP) pressures and Sniff Nasal Inspiratory Pressure (SNIP) - change in respiratory muscle strength
timeFrame: Assessment at baseline, post (3 months) and 3 months and 6 months follow-up for experimental and control groups.
measure: Quality of Life in Alzheimer's Disease scale - change in health-related quality of life
timeFrame: Assessment at baseline, post (3 months) and 3 months and 6 months follow-up for experimental and control groups.
measure: Short Form Zarit Burden Interview - change in caregivers' burden
timeFrame: Assessment at baseline, post (3 months) and 3 months and 6 months follow-up for experimental and control groups.
measure: Resource Utilization in Dementia - Lite - change in informal time provision
timeFrame: Assessment at baseline, post (3 months) and 3 months and 6 months follow-up for experimental and control groups.
Other outcomes:
Locations:
city: Aveiro
country: Portugal
facility: University of Aveiro
Study officials:
affiliation: School of Health Sciences of the University of Aveiro (ESSUA)
name: Alda S Marques, PhD
role: PRINCIPAL_INVESTIGATOR
References: