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Clinical Trial Summary

Medical condition or disease under investigation : Quantitative and qualitative aspects of sleep, quality of life, functional ability and well-being in older adults (>55years)

Purpose of clinical trial : To study the prospective effects of a walking intervention (Health promotion program) on quantitative and qualitative aspects of sleep, quality of life, functional ability and well-being in older adults.

Primary objective : Measure the effects of walking intervention on quantitative and qualitative aspects of sleep

Secondary objective (s) : Measure the effects of walking intervention on physical activity, quality of life, functional ability and well-being Social identity and leadership, social support and motivation

Trial Design : Intervention study : controlled before-and-after study

Sample Size : total sample size : 400 participants

Summary of eligibility criteria : Older adults aged above 55years

Included in intervention group : adults who are participating in the health promotion program 'Lekker Actief', organized by OKRA

Included in control group : waitlist controls of controls (adults, members of OKRA, not participating in the health promotion program 'Lekker Actief')

Maximum duration of treatment of a Subject :

- Start of Health promotion program 'Lekker Actief' : September 2018

- Measurements with accelerometers will start prior to the Health promotion program 'Lekker Actief' : July 2018

- End of Health promotion program 'Lekker Actief' : December 2018

- Duration of Health promotion program 'Lekker Actief': 12 weeks

- Follow up measurements : October-December 2019

- Maximal duration : July 2018-December 2019


Clinical Trial Description

this trial will consist of 3 visits : Pretest, Posttest and Follow up measurements

- Pretest measurements (week 0)

o Accelerometry : a subsample of participants form intervention and control groups (n=100) will be asked to wear an accelerometer (type GT3X) during 7 entire days prior to baseline measurements. (Timing : July-August 2018)

o Baseline measurements : during the start up moment of the program all participants from intervention and control groups will be asked : (Timing : September-October 2018)

- To fill out the self-reported questionnaire (survey) : the survey is composed of existing validated scales : IPAQ, PSQI, SF-12, WEMWBS, HAQ-DI. (references of validated scales are provided in the 'outcome measures' section)

- To perform a walk test over 20 meters in order to determine the individual stride length

- To perform a 6 minute walking test in order to self-report perceived exertion and physical fitness (by Borg Scale) and to determine the individual entry level of the program (entry levels vary between 1-12)

- To wear the Pedometer (Omron® Walking Style one 2.0) on a daily basis and register the amount of daily steps in their personal registration forms

- Posttest measurements (week 12)

- Accelerometry : a subsample of participants form intervention and control groups (n=100) will be asked to wear an accelerometer (type GT3X®) during 7 days prior to posttest measurements. (Timing : October-November 2018)

- Posttest measurements : at the end of the program all participants will be asked :

(Timing : October-December 2018)

- To fill out the self-reported questionnaire (survey). In addition to the pretest questionnaire, the validated scales ILI, Mael and Ashford (1992) and BREQ-3 will be added and will be filled out only by participants of the intervention groups

- To perform a 6 minute walking test in order to self-report perceived exertion and physical fitness (by Borg Scale)

- To inform the investigators on the amount of daily steps (measured with pedometer type : Omron® Walking Style one 2.0) during the 12 week program

- Focus groups : a subsample will be invited to take part in focus groups. During these focus groups, participants will be encouraged to discuss the program and possible effects in small groups (5 participants per group). A semi-structured interview guide will be used to guide the discussions.

• Follow-up measurements (1 year after completing the program)

- Accelerometry : a subsample of participants form intervention and control groups (n=100) will be asked to wear an accelerometer (type GT3X) during 7 days, one year after finishing the program (follow up measurements) (Timing : October-November 2019)

- Follow-up measurements : one year after completing the 12 week program, all participants will be asked :

(Timing : October-December 2019)

- To fill out the self-reported questionnaire (survey)

- To perform a 6 minute walking test in order to self-report perceived exertion and physical fitness (by Borg Scale) o Focus groups : a subsample will be invited to take part in focus groups. During these focus groups, participants will be encouraged to discuss the program and possible effects, 1 year after the program. The focus groups are organized in small groups (5 participants per group) and a semi-structured interview guide will be used to guide the discussions. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03576209
Study type Interventional
Source Katholieke Universiteit Leuven
Contact Julie Vanderlinden, Drs,Msc
Phone +32 16 32 18 61
Email julie.vanderlinden@kuleuven.be
Status Not yet recruiting
Phase N/A
Start date July 1, 2018
Completion date December 31, 2019

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