The Effects of a Walking Program on Balance, Falls and Well Being in Individuals Residing in Long-term Care
|ClinicalTrials.gov Identifier: NCT01277809|
Recruitment Status : Active, not recruiting
First Posted : January 17, 2011
Last Update Posted : June 23, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Accidental Falls Muscle Weakness Gait, Unsteady Depression Behavior||Behavioral: Interpersonal Interaction Behavioral: Walking Program||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||179 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||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|
|Study Start Date :||December 2010|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
No Intervention: Usual Care
Participants will receive care as usual (Usual Care Group; UCG) that is provided by their long-term care unit.
Active Comparator: Interpersonal Interaction
Participants will receive stationary 1:1 interaction time with the same research personnel who conduct the third group walking session at each individual care facility in order to control for the interpersonal interaction likely to be involved in the walking program. This group will receive the equivalent interpersonal interaction time with research personnel as those participating in the walking group. This interaction time will occur with the participant stationary, rather than walking with the researcher.
Behavioral: Interpersonal Interaction
Participants will receive stationary 1:1 interaction time with the same research personnel who conduct the third group walking session at each individual care facility in order to control for the interpersonal interaction likely to be involved in the walking program (Interpersonal Interaction Group; IIG). This group will receive the equivalent interpersonal interaction time with research personnel as those participating in the WPG group. This interaction time will occur with the participant stationary, rather than walking with the researcher.
Experimental: Walking Program
Participants will walk five times per week under the supervision of a licensed physiotherapist.
Behavioral: Walking Program
Participants will walk five times per week, supervised by a licensed physiotherapist. Subjects will in general gradually increase their daily supervised walking time as tolerated to a maximum of 30 minutes once per day. The distance and number of minutes walked each time will be recorded. Interpersonal interaction will occur during the walking sessions, and will be similar in quality and quantity to that during the Interpersonal Interaction Group.
- 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.
- Fitness [ Time Frame: Eight months ]The Senior Fitness Test (SFT) (Rikli & Jones 1999a; 1999b) will assess dynamic upper and lower extremity strength and flexibility, aerobic endurance, and dynamic balance and agility.
- Balance [ Time Frame: Eight months ]The Berg Balance Scale will be used to objectively assess a person's ability to safely perform several common daily living tasks
- Grip Strength [ Time Frame: Eight months ]Grip strength of the dominant and non-dominant hand-held dynamometer will be measured. Strength will be tested 3 times with each hand and the maximum score will be recorded
- Gait speed [ Time Frame: Eight months ]Participants will be asked to walk a distance of 6 metres over a portable, computerized walkway (the GAITRite® system (CIR Systems Inc., Clifton, NJ). An additional two metres of walking will be added at the beginning and end of the walkway to accommodate for acceleration and deceleration. Subjects will be asked to walk along the walkway. Gait parameters, including gait speed, will be recorded.
- Physical Activities of Daily Living [ Time Frame: Eight months ]OARS Physical Activities of Daily Living (PADL) Sub-Scale (Fillenbaum 1988)will be used as a clinical assessment of functional status. The OARS-PADL will be completed by the research assistant with information provided by subjects' care provider.
- Depression [ Time Frame: Eight months ]Mood will be assessed using the Cornell Scale for Depression in Dementia, a well- validated scale designed for the assessment of depression in individuals with dementia and individuals residing in long-term care. The CSDD will be completed by the research assistant with information provided by subjects' care provider.
- Behavioral problems [ Time Frame: Eight months ]Behavioral problems will be assessed with the use of the Revised Memory and Behavior Problems Checklist (RMBPC), a 24-item report that measures observable behavioral and memory problems (Appendix). The RMBPC will be completed by the research assistant with information provided by subjects' care provider.
- Vital signs [ Time Frame: Eight months ]We will measure lying and standing blood pressure as well as heart rate and respiratory rate at baseline and every two months throughout the study.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01277809
|Saskatoon Health Region|
|Saskatoon, Saskatchewan, Canada, S7K 0M7|
|Principal Investigator:||Lilian U Thorpe, MD, PhD||University of Saskatchewan|
|Principal Investigator:||Vanina Dal Bello-Haas, Ph. D, P.T.||McMaster University|