Condition category
Not Applicable
Date applied
21/09/2012
Date assigned
23/10/2012
Last edited
23/01/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Mrs Marieke van Schijndel-Speet

ORCID ID

Contact details

Erasmus Medical Center Rotterdam
Department of Intellectual Disability Medicine
PO box 2040
Rotterdam
3000 CA
Netherlands

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

http://www.zonmw.nl/en/

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

  1. 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.

Additional files

Editorial Notes