Lifestyle Integrated Functional Exercise for People With Dementia: a Home-based Physical Activity Program

NCT ID: NCT03757806

Last Updated: 2022-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2021-05-01

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.

Conditions

Dementia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental group

The experimental group will receive the LiFE4D in addition to usual care (e.g., pharmacologic treatment).

Group Type: EXPERIMENTAL

Experimental group

Intervention Type: OTHER

LiFE4D is an individualised programme, adapted to the participant's needs/preferences.

People with Dementia will receive assistance to increase their physical activity multiple times/day in their everyday tasks with the support/supervision of their caregivers.

The programme last for 12 weeks, with a lower face tracking over time with the health professional but replaced by caregivers. The intervention includes face-to-face sessions and phone calls. Face-to-face sessions aim to adapt physical activity to everyday tasks, increase tasks frequency and intensity, monitor progress, clarify doubts, motivate and manage expectations. Phone calls aim to monitor motivation/evolution and clarify doubts.

Control group

The control group will receive usual care only.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Experimental group

LiFE4D is an individualised programme, adapted to the participant's needs/preferences.

People with Dementia will receive assistance to increase their physical activity multiple times/day in their everyday tasks with the support/supervision of their caregivers.

The programme last for 12 weeks, with a lower face tracking over time with the health professional but replaced by caregivers. The intervention includes face-to-face sessions and phone calls. Face-to-face sessions aim to adapt physical activity to everyday tasks, increase tasks frequency and intensity, monitor progress, clarify doubts, motivate and manage expectations. Phone calls aim to monitor motivation/evolution and clarify doubts.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

School of Health, Polytechnic Institute of Setúbal (ESS/IPS)

UNKNOWN

Sponsor Role: collaborator

Aveiro University

OTHER

Sponsor Role: lead

Responsible Party

Alda Sofia Pires de Dias Marques

Senior lecturer, Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alda S Marques, PhD

Role: PRINCIPAL_INVESTIGATOR

School of Health Sciences of the University of Aveiro (ESSUA)

Locations

University of Aveiro

Aveiro, , Portugal

Countries

Portugal

Other Identifiers

SFRH/BD/120695/2016

Identifier Type: -

Identifier Source: org_study_id