The Effects of a Walking Program on Balance, Falls and Well Being in Individuals Residing in Long-term Care
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|ClinicalTrials.gov Identifier: NCT01277809|
Recruitment Status : Active, not recruiting
First Posted : January 17, 2011
Last Update Posted : June 23, 2017
|First Submitted Date ICMJE||January 13, 2011|
|First Posted Date ICMJE||January 17, 2011|
|Last Update Posted Date||June 23, 2017|
|Study Start Date ICMJE||December 2010|
|Estimated Primary Completion Date||December 2018 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
||Falls [ Time Frame: Eight months ]
The incidence and nature of falls will be prospectively collected using a simple daily Fall Diary for the period of the intervention (4 months) and for 4 months following intervention. The Fall Diary will be kept at the residents' bedside and will staff will be asked to record the nature and location of the fall, activity and symptoms at the time of the fall, type of footwear, injuries resulting from the fall. Diaries will be collected every week by study personnel.
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT01277809 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||The Effects of a Walking Program on Balance, Falls and Well Being in Individuals Residing in Long-term Care|
|Official Title ICMJE||Community Alliance for Quality of Life in Long Term Care: The Effects of a Walking Program on Balance, Falls and Well Being in Individuals Residing in Long-term Care|
The purpose of this study is to assess the effectiveness of a regular walking program (which inevitably involves human interaction) compared to a usual care condition and to a human interaction condition (without the extra walking program) in individuals residing in Long-Term Care (LTC). Outcomes of interest include: balance, strength, mobility, endurance, walking distance; rate and severity of falls; activities of daily living; mood and behaviour.
It is hypothesized that participants taking part in the walking program will demonstrate maximal benefits compared to the no treatment control group (usual care) and the participants who will only receive social interaction. It is expected that benefits of the walking program will include decreased fall rates, and improved balance, endurance, strength, mood, behaviour, activities of daily living and quality of life indices. Given research findings that the addition of pleasant activities improves resident mood (Teri et al, 1997; 2003), it is expected that participants in the social interaction only group will demonstrate improvements in mood and other indices of quality of life.
Residents in LTC facilities in the Saskatoon Health Region and Regina Qu'Appelle Region will be recruited.
Inclusion criteria: Male or female residents who are able to follow simple instructions, who can ambulate with or without a walking aid for at least 10 meters, and who are willing to participate in the study procedures will be eligible to participate in the study.
Exclusion criteria: Residents who have experienced a recent cardiovascular event (within past 6 months) or have severe arthritis, cardiac instability, a vestibular disorder, uncontrolled hypertension, uncontrolled epilepsy, a recent fracture (past 4 months), who have had a recent admission into an acute care facility (past 4 months), who are scheduled for surgery or hospitalization in next 6 months or who are participating in another regular exercise program (three or more times per week) aimed at improving balance or strength will be excluded from the study.
Based on the sample size calculations, a sample size of 129 participants will provide ample power for the repeated measures analyses. Data will be collected from an additional 50 participants in order to deal with the possibility of attrition. Thus, total sample size is 179 participants.
The investigators will meet with the LTC facilities' administrators and staff to inform them of the study, inclusion and exclusion criteria, study procedures and interventions. They will be provided with copies of a one page information form which includes a space for residents (or substitute medical decision-maker, if appropriate) to indicate their signed consent to be approached by research staff with more detailed information (Appendix). Staff will provide this form to potential/eligible subjects, and will collect these forms when completed. Subjects who have consented to be contacted by research staff will be provided with more detailed information about the study by the research coordinator. If the resident is in agreement, he or she will then give written consent and will be entered into the study. The consent will include written permission for researchers to consult with the subject's family physician about the subject's health, and to ensure optimization of vitamin D intake prior to enrollment.
Although some subjects may have cognitive problems, the majority of subjects will be clearly competent to provide their own consent. However, some subjects may have more advanced cognitive problems than others and may therefore not fully appreciate the consequences of participation. In this situation the person who normally provides consent for medical treatment will provide appropriate consent. When capacity to provide full, informed consent is not clear, both the subject and the substitute decision-maker will be asked to sign the consent forms.
Step 1: Baseline assessment. All participants regardless of group will undergo the following assessments. The assessment of the outcome measures will be conducted by trained study personnel who will be blinded to group allocation.
The participant's family physician will be asked to optimize vitamin D level of participants at baseline according to Canadian guidelines, as this can impact fall risk. This will involve measuring the Vitamin D level at baseline, and ordering Vitamin D 1,000 units daily if the participant is not already taking this.
Step 2: Randomization into one of three groups:
Participants will wear a gait belt during all and with walking (if in the walking program group) and will be closely monitored by the research assistant who will be trained in safety issues.
Step 3: Subjects will participate in a four month intervention, as outlined in Step 2 above.
Step 4: After 2 months of the intervention (outlined in Step 2 above), all subjects will be re-tested as per baseline assessment (Step 1) with the exception of height and knee-floor height.
Step 5: After 4 months of intervention (outlined in Step 2 above), all subjects will be re-tested as per baseline assessment (Step 1) with the exception of height and knee-floor height.
Step 6: At 2 months and 4 months post-intervention, all subjects will be re-tested as per baseline assessment (Step 1) with the exception of height and knee-floor height.
A. In order to control for confounding variables and to characterize the sample, the following data will be extracted from the chart, including the chart copy of admission, date of admission, personal health number and most recent quarterly Minimum Data Set (MDS), by research personnel. The MDS is a computerized long-term care assessment system designed to improve the care given to long-term care residents, and has been utilized province-wide since 2001. Personal identifying information will only be extracted for the purpose of accurate linking to other study information, and will be removed prior to data analysis.
Data to be collected: date of birth, race/ethnicity, gender, highest level of education, diagnoses on admittance, medications, health conditions (CHESS Scale: health instability); Cognitive Performance Scale; Depression Rating Scale; Index of Social Engagement; ADL Self-Performance Hierarchy Scale; Pain; Continence; Oral/Nutritional status; Communication; Mood and Behaviour Patterns; Physical Functioning and Structural problems; Activity Pursuit Patterns; Special Treatments and Procedures.
B. Record of Falls: The incidence and nature of falls will be prospectively collected from the standard Saskatoon Health Region falls documentation for the period of the intervention (4 months) and for 4 months following intervention. Copies of falls documentation will be made from the clinical chart every week by study personnel.
Any participants' health concerns (identified by the participant and/or nursing staff) will be reviewed by the research coordinator and discussed with the Medical Safety Committee as appropriate.
7. Time Period (indicate the dates when the research project is expected to begin and to be completed. A final status report must be filed with the Ethics Office once data collection from the last subject is complete. The Ethics Office should be notified once the study site is closed.):
Anticipated start date is December 2010. We anticipate the study will take about 2 years to complete. Expected completion date is December 31, 2016.
8. Data Storage (In accordance with recommended guidelines provide a statement outlining the procedures you will use to store securely the research data. State how long and where the data will be stored and identify the person who will be assuming responsibility for data storage):
Study participant information will be stored according to HIPA guidelines. All documents and data collection forms will be stored in the School of Physical Therapy, in a locked filing cabinet in the office of Vanina Dal Bello-Haas (P.I.) for the required 10-year period. Signed consent forms will be stored separately from the study data in locked files. Study subjects will be identified by research study number only. Only study numbers and aggregate information will be used for data analysis.
|Study Type ICMJE||Interventional|
|Study Phase||Not Applicable|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
|Publications *||Dal Bello-Haas VP, Thorpe LU, Lix LM, Scudds R, Hadjistavropoulos T. The effects of a long-term care walking program on balance, falls and well-being. BMC Geriatr. 2012 Dec 18;12:76. doi: 10.1186/1471-2318-12-76.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Active, not recruiting|
|Estimated Enrollment ICMJE
|Original Estimated Enrollment ICMJE||Same as current|
|Estimated Study Completion Date||December 2018|
|Estimated Primary Completion Date||December 2018 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
|Ages||60 Years and older (Adult, Older Adult)|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Canada|
|Removed Location Countries|
|NCT Number ICMJE||NCT01277809|
|Other Study ID Numbers ICMJE||BIO-BEB 10-125|
|Has Data Monitoring Committee||No|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Lilian Thorpe, University of Saskatchewan|
|Study Sponsor ICMJE||University of Saskatchewan|
|Collaborators ICMJE||Saskatchewan Health Research Foundation|
|PRS Account||University of Saskatchewan|
|Verification Date||June 2017|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP