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

LiFE4D: a Home-based Physical Activity Program for Community-dwelling People With Dementia

Sponsors

Lead Sponsor: Aveiro University

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

Source Aveiro University
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.

Overall Status Recruiting
Start Date December 1, 2018
Completion Date May 1, 2021
Primary Completion Date August 1, 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
2 Minute Step test - change in exercise tolerance Assessment at baseline, post (3 months) and 3 months and 6 months follow-up for experimental and control groups.
Secondary Outcome
Measure Time Frame
Addenbrooke's Cognitive Examination III - change in cognitive function Assessment at baseline, post (3 months) and 3 months and 6 months follow-up for experimental and control groups.
Brief Balance Evaluation System Test - change in balance Assessment at baseline, post (3 months) and 3 months and 6 months follow-up for experimental and control groups.
Brief Physical Activity Assessment tool - change in self-reported physical activity Assessment at baseline, post (3 months) and 3 months and 6 months follow-up for experimental and control groups.
Accelerometer-based activity monitors - change in physical activity levels Assessment at baseline, post (3 months) and 3 months and 6 months follow-up for experimental and control groups.
Handgrip Dynamometer - change in maximum isometric strength of the hand and forearm muscles Assessment at baseline, post (3 months) and 3 months and 6 months follow-up for experimental and control groups.
30 second sit to stand test - change in lower limb strength Assessment at baseline, post (3 months) and 3 months and 6 months follow-up for experimental and control groups.
Grocery Shelving Task - change in upper limb functionality Assessment at baseline, post (3 months) and 3 months and 6 months follow-up for experimental and control groups.
Chair sit and reach test - change in flexibility Assessment at baseline, post (3 months) and 3 months and 6 months follow-up for experimental and control groups.
Functional Reach Test - change in functionality Assessment at baseline, post (3 months) and 3 months and 6 months follow-up for experimental and control groups.
Timed Up and Go test - change in functional mobility Assessment at baseline, post (3 months) and 3 months and 6 months follow-up for experimental and control groups.
Physical Performance Test - change in overall functionality Assessment at baseline, post (3 months) and 3 months and 6 months follow-up for experimental and control groups.
Peak Flow Meter - change in lung function Assessment at baseline, post (3 months) and 3 months and 6 months follow-up for experimental and control groups.
Maximal inspiratory (MIP) and expiratory (MEP) pressures and Sniff Nasal Inspiratory Pressure (SNIP) - change in respiratory muscle strength Assessment at baseline, post (3 months) and 3 months and 6 months follow-up for experimental and control groups.
Quality of Life in Alzheimer's Disease scale - change in health-related quality of life Assessment at baseline, post (3 months) and 3 months and 6 months follow-up for experimental and control groups.
Short Form Zarit Burden Interview - change in caregivers' burden Assessment at baseline, post (3 months) and 3 months and 6 months follow-up for experimental and control groups.
Resource Utilization in Dementia - Lite - change in informal time provision Assessment at baseline, post (3 months) and 3 months and 6 months follow-up for experimental and control groups.
Enrollment 76
Condition
Intervention

Intervention Type: Other

Intervention Name: Experimental group

Description: 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.

Arm Group Label: Experimental group

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Alda S Marques, PhD Principal Investigator School of Health Sciences of the University of Aveiro (ESSUA)
Overall Contact

Last Name: Alda S Marques, PhD

Phone: 00351234372462

Email: [email protected]

Location
Facility: Status: Contact: Investigator: University of Aveiro Alda S Marques, PhD 00351 234 372 462 [email protected] Alda S Marques, PhD Principal Investigator
Location Countries

Portugal

Verification Date

July 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Aveiro University

Investigator Full Name: Alda Sofia Pires de Dias Marques

Investigator Title: Senior lecturer, Dr.

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Experimental group

Type: Experimental

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

Label: Control group

Type: No Intervention

Description: The control group will receive usual care only.

Acronym LiFE4D
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

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

Masking: None (Open Label)

Source: ClinicalTrials.gov