NCT01277809

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
179

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 13, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 17, 2011

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 19, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 19, 2018

Completed
Last Updated

October 23, 2018

Status Verified

October 1, 2018

Enrollment Period

7.9 years

First QC Date

January 13, 2011

Last Update Submit

October 19, 2018

Conditions

Keywords

Long term careAgingAccidental FallsMuscle WeaknessGaitPhysical FitnessMuscle StrengthPostural BalanceActivities of Daily LivingBody WeightBlood PressureDepressionBehaviorDementia

Outcome Measures

Primary Outcomes (1)

  • Falls

    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.

    Eight months

Secondary Outcomes (8)

  • Fitness

    Eight months

  • Balance

    Eight months

  • Grip Strength

    Eight months

  • Gait speed

    Eight months

  • Physical Activities of Daily Living

    Eight months

  • +3 more secondary outcomes

Study Arms (3)

Usual Care

NO INTERVENTION

Participants will receive care as usual (Usual Care Group; UCG) that is provided by their long-term care unit.

Interpersonal Interaction

ACTIVE COMPARATOR

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

Walking Program

EXPERIMENTAL

Participants will walk five times per week under the supervision of a licensed physiotherapist.

Behavioral: Walking Program

Interventions

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.

Interpersonal Interaction
Walking ProgramBEHAVIORAL

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.

Walking Program

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults residing in a long term care facility
  • Able to follow simple instructions
  • Can ambulate with or without a walking aid for at least 10 meters

You may not qualify if:

  • Cardiovascular event within past 6 months
  • Severe arthritis
  • Clinical significant vestibular disorder
  • Uncontrolled hypertension
  • Uncontrolled epilepsy
  • Fracture within the past 4 months
  • Admission into an acute care facility in last 4 months
  • Scheduled for surgery or hospitalization in next 6 months
  • Already participating in another regular exercise program (three or more times per week) aimed at improving balance or strength

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saskatoon Health Region

Saskatoon, Saskatchewan, S7K 0M7, Canada

Location

Related Publications (2)

  • Kalu ME, Dal Bello-Haas V, Hadjistavropoulos T, Thorpe L, Griffin M, Ploeg J, Richardson J. The Effects of a Walking Intervention on Gait Parameters in Older Adults Residing in Long-Term Care: A Randomized Controlled Trial. J Nutr Health Aging. 2021;25(9):1099-1105. doi: 10.1007/s12603-021-1683-6.

  • 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.

MeSH Terms

Conditions

Muscle WeaknessGait Disorders, NeurologicDepressionBehaviorBody WeightDementia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsBehavioral SymptomsBrain DiseasesCentral Nervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Lilian U Thorpe, MD, PhD

    University of Saskatchewan

    PRINCIPAL INVESTIGATOR
  • Vanina Dal Bello-Haas, Ph. D, P.T.

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

January 13, 2011

First Posted

January 17, 2011

Study Start

December 1, 2010

Primary Completion

October 19, 2018

Study Completion

October 19, 2018

Last Updated

October 23, 2018

Record last verified: 2018-10

Locations