Plain English Summary
Background and study aims:
The aim of our study is to improve the physical activity level in seniors with an intellectual disability. Regular physical activity is very important to their health and is specifically important for the prevention and reduction of falls and functional limitations. We developed a new physical activity program and we determined if it indeed improved the physical activity and health of the seniors.
Who can participate?
People with a mild or moderate intellectual disability, aged 45 years and older.
What does the study involve?
The physical activity program will be conducted in the participants day care centers. Day care centers will be randomly allocated to participate in the program or serve as a control group. Those who participate in the study will be divided into two groups. One group will conduct the physical activity program for eight months, three times a week. The program includes education about the importance of physical activity to their health and performing physical activities.
The other group will conduct normal activities at the day care center as usual; there will be no changes in their daily program.
What are the possible benefits and risks of participating?
Participants will learn about the importance of physical activity and increase their self-confidence and enjoyment in participating in physical activities. Participants who will actively perform the physical activities, will become more healthy and their fitness may increase and they will feel more flexible and fit. Before the program starts, the general practitioner will be asked to provide a medical advice about participating safely. If no positive advice is provided, the participant cannot continue in the program. Heart-rate monitors will be used to evaluate the heart-rate changes during the activities. If there are falls or other undesirable situations, the researcher, the conductors and physical therapist and or the general practitioner will discuss the continuation of the program.
Where is the study run from?
Ipse de Bruggen and Amarant en Abrona
When is study starting and how long is it expected to run for?
The study started in March 2010 and the last health measurements were taken in October 2011.
Who is funding the study?
The Netherlands Organization for Health Research and Development ref: 57000003
Who is the main contact?
Professor Heleen M Evenhuis
h.evenhuis@debruggen.nl
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
57000003 / 62-614000-98-006_02
Study information
Scientific title
Improving physical activity among older adults with a mild or moderate intellectual disability by a structured day care program: a cluster randomized trial
Acronym
IPAD-ID
Study hypothesis
The physical activity level of participants will improve, whereas the physical activity level of the control group remains on the same (low) level.
The physical fitness level of participants will remain equal or will improve a little, whereas the physical fitness level of the control group remains equal or declines. This hypothesis is also applicable to the secondary outcome measures.
Ethics approval
Erasmus University Medical Center Ethics Committee, 03 December 2009 ref: NL 29573.078.09
Study design
Cluster randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Seniors with a mild or moderate intellectual disability with a low physical activity level. Also a low fitness level is to be expected.
Intervention
Participants:
1: physical activity program, during eight months, three times a week, 45 minutes per time AND
2: an education program, during eight months, two times a week, 45 minutes per time
Control group: No intervention.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Physical activity (Steps per day)
Secondary outcome measures
1. Motor fitness (strength, balance, walking speed)
2. Cardio respiratory fitness (blood pressure, aerobic capacity)
3. Morphological fitness (weight, waist circumference, skin fold measurements)
4. Metabolic fitness (glucose, cholesterol)
5. Functioning in daily life (mobility, ADL, IADL, depression, functional deterioration)
6. Chronic illness
7. Quality of life
8. Interviews with seniors and/or their staff (Motivation, Quality of life)
9. Physical measurements on seniors (Motor fitness, Cardio respiratory fitness, Morphological fitness, Metabolic fitness, Functioning in daily life),
10. Questionnaires to be filled in by staff (Functioning in daily life)
11. Medical files (Chronic illness)
Overall trial start date
01/03/2010
Overall trial end date
01/11/2011
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged 50 years and over (1-9-2010), maximum 75 years old
2. Mild or moderate intellectual disability
3. Being able to participate in activities in groups of around 10 seniors with ID
4. Being able to conduct physical activities after demonstration by staff
5. Being able to wear a pedometer during several days
6. Having sufficient visual function to performing fitness measurements
7. Declaration of physician that the senior is able to perform physical activities safely, in view of his medical condition
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
160 participants: 80 participants and 80 controls
Participant exclusion criteria
1. Seniors with moderate or severe pain when moving will be excluded from the study
2. Seniors with an active lifestyle will be excluded from the study (more than 7500 steps per day)
Recruitment start date
01/03/2010
Recruitment end date
01/11/2011
Locations
Countries of recruitment
Netherlands
Trial participating centre
Erasmus Medical Center Rotterdam
Rotterdam
3000 CA
Netherlands
Sponsor information
Organisation
The Netherlands Organization for Health Research and Development (Netherlands)
Sponsor details
Laan van Nieuw Oost- Indie 334
The Hague
2593 CE
Netherlands
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
The Netherlands Organization for Health Research and Development (Netherlands) ref: 57000003
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23938154
Publication citations
-
Protocol
van Schijndel-Speet M, Evenhuis HM, van Empelen P, van Wijck R, Echteld MA, Development and evaluation of a structured programme for promoting physical activity among seniors with intellectual disabilities: a study protocol for a cluster randomized trial., BMC Public Health, 2013, 13, 746, doi: 10.1186/1471-2458-13-746.