- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04861831
Power Centering for Seniors (PCS)
January 31, 2022 updated by: University Department of Geriatric Medicine FELIX PLATTER
Power Centering for Seniors: A Multimodal Intervention to Improve Mobility and Quality of Life in Older Adults
Walking difficulties, mobility decline and falls are prevalent among older adults.
The incidence of each of these increases with age and the presence of each can negatively affect the quality of life in older adults.
The purpose of this prospective clinical trial is to evaluate the efficacy of the Power Centering for Seniors multimodal, twice weekly, 12-week group intervention program to improve the mobility and quality of life in older, community-dwelling adults.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
63
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Basel, Switzerland, 4055
- University Department of Geriatric Medicine FELIX PLATTER
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
70 years and older (Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 70 years or older
- Community-dwellers (i.e. not living in a skilled care or other institution)
- Able to walk at least 5 meters with or without a walking aid but without the assistance of another person
- Normal (habitual, self-paced) walking speed 80-100 cm/s
- Montreal Cognitive Assessment score 18 or more points
- lnformed Consent as documented by signature
Exclusion Criteria:
- Clinically significant neurologic or musculoskeletal diseases which severely affect walking, e.g. advanced Parkinson's disease or hemiplegia
- Other clinically significant non-stable medical or psychiatric conditions (e.g., renal failure, hepatic dysfunction, cardiovascular disease, advanced chronic pulmonary disease, psychosis, schizoaffective disorder, etc.) that, according to the study investigators, could endanger the participant and/or negatively affect study adherence
- Terminal illness
- Fracture (exception: teeth) in the previous 3 months
- Blindness
- lnability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- Previous participation in the Power Centering for Seniors program
- Current participation in another (non-observational) clinical study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Immediate PCS Intervention
After the pre-intervention clinical assessments, immediate (within one week) begin with the PCS exercise program (75-minute group class, twice weekly for 12 weeks; home practice of exercises recommended but not required).
Post-intervention clinical assessments within one week after the last intervention class, followed by a 12-week follow-up period (continuation of exercise program at home recommended but not required).
Final clinical assessments within one week after the 12-week follow-up period.
|
Power Centering for Seniors is an innovative East-meets-West intervention (75-minute, twice weekly, supervised group classes over 12 weeks) that integrates Western best practice muscle strength and balance training components with Chinese Tai Chi/Qi Gong to improve mobility and quality of life in older, community-dwelling adults.
Home practice is recommended (approximately 30 minutes three times per week on non-course days).
The modularly designed course consists of four cycles with six themes repeated in each cycle.
Course exercises increase in intensity throughout the twelve-week intervention period.
Repetition of cycles and themes prepares participants for continuing their individualized version of the program after the group course intervention is complete.
This should lead to long-term practice of the exercises learned in the intervention and to sustained positive effects of the training.
|
|
Experimental: Delayed PCS Intervention
During the 12 weeks that the Immediate Intervention (II) group participates in the PCS intervention, the Delayed Intervention (DI) group waits (there is no control intervention) and serves as a control arm comparison for the II group during this time.
After the 12 weeks, the DI group will undergo a second pre-intervention assessment to document any change in baseline measures that may have occurred in those 12 weeks.
No significant changes are expected.
The DI group then begins the same exercise intervention (75-minute group class, twice weekly for 12 weeks; home practice of exercises recommended but not required) that the II group underwent, given by the same instructors.
Post-intervention clinical assessments, 12-week follow-up period, and final clinical assessments after the follow-up period as described for the II group.
After the trial, pooled data from both groups will provide results on the overall changes in outcome measures post- versus pre-intervention.
|
Power Centering for Seniors is an innovative East-meets-West intervention (75-minute, twice weekly, supervised group classes over 12 weeks) that integrates Western best practice muscle strength and balance training components with Chinese Tai Chi/Qi Gong to improve mobility and quality of life in older, community-dwelling adults.
Home practice is recommended (approximately 30 minutes three times per week on non-course days).
The modularly designed course consists of four cycles with six themes repeated in each cycle.
Course exercises increase in intensity throughout the twelve-week intervention period.
Repetition of cycles and themes prepares participants for continuing their individualized version of the program after the group course intervention is complete.
This should lead to long-term practice of the exercises learned in the intervention and to sustained positive effects of the training.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gait speed
Time Frame: II Group: pre-intervention (Week 1), post-intervention (Week 12), post-follow-up (Week 24); DI Group: first pre-intervention (Week 1), second pre-intervention (Week 12), post-intervention (Week 24), post-follow-up (Week 36)
|
Change in the ratio of post- to pre-intervention normal (habitual, self-selcted) walking speed (cm/s) in the immediate intervention group compared to the ratio of post- to pre-waiting normal walking speed in the delayed intervention group.
|
II Group: pre-intervention (Week 1), post-intervention (Week 12), post-follow-up (Week 24); DI Group: first pre-intervention (Week 1), second pre-intervention (Week 12), post-intervention (Week 24), post-follow-up (Week 36)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cadence
Time Frame: II Group: pre-intervention (Week 1), post-intervention (Week 12), post-follow-up (Week 24); DI Group: first pre-intervention (Week 1), second pre-intervention (Week 12), post-intervention (Week 24), post-follow-up (Week 36)
|
Cadence (number of steps per minute) quantified during gait analysis using the GAITRite electronic walkway system
|
II Group: pre-intervention (Week 1), post-intervention (Week 12), post-follow-up (Week 24); DI Group: first pre-intervention (Week 1), second pre-intervention (Week 12), post-intervention (Week 24), post-follow-up (Week 36)
|
|
Base of support
Time Frame: II Group: pre-intervention (Week 1), post-intervention (Week 12), post-follow-up (Week 24); DI Group: first pre-intervention (Week 1), second pre-intervention (Week 12), post-intervention (Week 24), post-follow-up (Week 36)
|
Base of support (cm), the distance between heels, quantified during gait analysis using the GAITRite electronic walkway system.
|
II Group: pre-intervention (Week 1), post-intervention (Week 12), post-follow-up (Week 24); DI Group: first pre-intervention (Week 1), second pre-intervention (Week 12), post-intervention (Week 24), post-follow-up (Week 36)
|
|
Step width variability
Time Frame: II Group: pre-intervention (Week 1), post-intervention (Week 12), post-follow-up (Week 24); DI Group: first pre-intervention (Week 1), second pre-intervention (Week 12), post-intervention (Week 24), post-follow-up (Week 36)
|
Step width variability (%) quantified during gait analysis using the GAITRite electronic walkway system.
Variability calculated by the coefficient of varation=(standard deviation/mean)x100.
|
II Group: pre-intervention (Week 1), post-intervention (Week 12), post-follow-up (Week 24); DI Group: first pre-intervention (Week 1), second pre-intervention (Week 12), post-intervention (Week 24), post-follow-up (Week 36)
|
|
Single support time
Time Frame: II Group: pre-intervention (Week 1), post-intervention (Week 12), post-follow-up (Week 24); DI Group: first pre-intervention (Week 1), second pre-intervention (Week 12), post-intervention (Week 24), post-follow-up (Week 36)
|
Single support time (s), an indirect measure of dynamic balance and gait certainty, quantified during gait analysis using the GAITRite electronic walkway system
|
II Group: pre-intervention (Week 1), post-intervention (Week 12), post-follow-up (Week 24); DI Group: first pre-intervention (Week 1), second pre-intervention (Week 12), post-intervention (Week 24), post-follow-up (Week 36)
|
|
Double support time
Time Frame: II Group: pre-intervention (Week 1), post-intervention (Week 12), post-follow-up (Week 24); DI Group: first pre-intervention (Week 1), second pre-intervention (Week 12), post-intervention (Week 24), post-follow-up (Week 36)
|
Double support time (s), an indirect measure of dynamic balance and gait certainty, quantified during gait analysis using the GAITRite electronic walkway system
|
II Group: pre-intervention (Week 1), post-intervention (Week 12), post-follow-up (Week 24); DI Group: first pre-intervention (Week 1), second pre-intervention (Week 12), post-intervention (Week 24), post-follow-up (Week 36)
|
|
Stride time
Time Frame: II Group: pre-intervention (Week 1), post-intervention (Week 12), post-follow-up (Week 24); DI Group: first pre-intervention (Week 1), second pre-intervention (Week 12), post-intervention (Week 24), post-follow-up (Week 36)
|
Stride time (s), also referred to as gait cycle time, quantified during gait analysis using the GAITRite electronic walkway system
|
II Group: pre-intervention (Week 1), post-intervention (Week 12), post-follow-up (Week 24); DI Group: first pre-intervention (Week 1), second pre-intervention (Week 12), post-intervention (Week 24), post-follow-up (Week 36)
|
|
Stride time variability
Time Frame: II Group: pre-intervention (Week 1), post-intervention (Week 12), post-follow-up (Week 24); DI Group: first pre-intervention (Week 1), second pre-intervention (Week 12), post-intervention (Week 24), post-follow-up (Week 36)
|
Stride time variability (percent) quantified during gait analysis using the GAITRite electronic walkway system.
Variability calculated by the coefficient of varation=(standard deviation/mean)x100.
|
II Group: pre-intervention (Week 1), post-intervention (Week 12), post-follow-up (Week 24); DI Group: first pre-intervention (Week 1), second pre-intervention (Week 12), post-intervention (Week 24), post-follow-up (Week 36)
|
|
Swing time
Time Frame: II Group: pre-intervention (Week 1), post-intervention (Week 12), post-follow-up (Week 24); DI Group: first pre-intervention (Week 1), second pre-intervention (Week 12), post-intervention (Week 24), post-follow-up (Week 36)
|
Swing time (s), the time one leg is in the air during one gait cycle, quantified during gait analysis using the GAITRite electronic walkway system.
|
II Group: pre-intervention (Week 1), post-intervention (Week 12), post-follow-up (Week 24); DI Group: first pre-intervention (Week 1), second pre-intervention (Week 12), post-intervention (Week 24), post-follow-up (Week 36)
|
|
Swing time variability
Time Frame: II Group: pre-intervention (Week 1), post-intervention (Week 12), post-follow-up (Week 24); DI Group: first pre-intervention (Week 1), second pre-intervention (Week 12), post-intervention (Week 24), post-follow-up (Week 36)
|
Swing time variability (percent) quantified during gait analysis using the GAITRite electronic walkway system.
Variability calculated by the coefficient of varation=(standard deviation/mean)x100.
|
II Group: pre-intervention (Week 1), post-intervention (Week 12), post-follow-up (Week 24); DI Group: first pre-intervention (Week 1), second pre-intervention (Week 12), post-intervention (Week 24), post-follow-up (Week 36)
|
|
Timed Up and Go Test
Time Frame: II Group: pre-intervention (Week 1), post-intervention (Week 12), post-follow-up (Week 24); DI Group: first pre-intervention (Week 1), second pre-intervention (Week 12), post-intervention (Week 24), post-follow-up (Week 36)
|
Standardized assessment of general mobility in older adults, time measured in seconds using a stopwatch
|
II Group: pre-intervention (Week 1), post-intervention (Week 12), post-follow-up (Week 24); DI Group: first pre-intervention (Week 1), second pre-intervention (Week 12), post-intervention (Week 24), post-follow-up (Week 36)
|
|
Timed Up and Go Test, imagined
Time Frame: II Group: pre-intervention (Week 1), post-intervention (Week 12), post-follow-up (Week 24); DI Group: first pre-intervention (Week 1), second pre-intervention (Week 12), post-intervention (Week 24), post-follow-up (Week 36)
|
After performing the Timed Up and Go Test, the participant remains seated and imagines performing the Timed Up and Go Test.
Test time is measured in seconds using a stopwatch.
Time for imagined test performance that is twice as fast or faster than real test performance time reflect possible cognitive difficulties as well as walking difficulties, particularly under dual or multi-task conditions.
|
II Group: pre-intervention (Week 1), post-intervention (Week 12), post-follow-up (Week 24); DI Group: first pre-intervention (Week 1), second pre-intervention (Week 12), post-intervention (Week 24), post-follow-up (Week 36)
|
|
Short Physical Performance Battery
Time Frame: II Group: pre-intervention (Week 1), post-intervention (Week 12), post-follow-up (Week 24); DI Group: first pre-intervention (Week 1), second pre-intervention (Week 12), post-intervention (Week 24), post-follow-up (Week 36)
|
Standardized assessment of physical performance with measurements of muscle strength, balance and walking.
Results range from 0 to 12 points, higher point score represents better physical performance.
|
II Group: pre-intervention (Week 1), post-intervention (Week 12), post-follow-up (Week 24); DI Group: first pre-intervention (Week 1), second pre-intervention (Week 12), post-intervention (Week 24), post-follow-up (Week 36)
|
|
Continuous Scale of Physical Functional Performance Test
Time Frame: II Group: pre-intervention (Week 1), post-intervention (Week 12), post-follow-up (Week 24); DI Group: first pre-intervention (Week 1), second pre-intervention (Week 12), post-intervention (Week 24), post-follow-up (Week 36)
|
Strandardized assessment of physical functional performance of 10 tasks of daily living.
Task results measured as time (s), weight (kg) and/or distance (cm or m, depending on task) are transformed by the assessment software into scaled scores ranging from 0 to 100 points, with higher point scores reflecting better performance and greater liklihood of independent living.
Total score (0-100 points) and well as subscores (0-100 points) of five domains of physical functional perfomance are provided: upper body strength, upper body flexibility, lower body strength, balance and coordination, and endurance
|
II Group: pre-intervention (Week 1), post-intervention (Week 12), post-follow-up (Week 24); DI Group: first pre-intervention (Week 1), second pre-intervention (Week 12), post-intervention (Week 24), post-follow-up (Week 36)
|
|
Physical Activity Scale for the Elderly
Time Frame: II Group: pre-intervention (Week 1), post-intervention (Week 12), post-follow-up (Week 24); DI Group: first pre-intervention (Week 1), second pre-intervention (Week 12), post-intervention (Week 24), post-follow-up (Week 36)
|
Standardized, self-report questionnaire to measure physical activity levels in older people as well as to assess the effectiveness of exercise interventions.
From a list of 12 types of activities and referring to the previous week, participants report how many days per week and for how many hours per day they performed each activity.
Scores are calculated by multiplying the weight (activity weights are provided in a table for PASE scoring) by the frequency values for each of 12 types of activities.
Scores may range from zero to 400 or more.
Higher scores reflect higher levels of physical activity.
|
II Group: pre-intervention (Week 1), post-intervention (Week 12), post-follow-up (Week 24); DI Group: first pre-intervention (Week 1), second pre-intervention (Week 12), post-intervention (Week 24), post-follow-up (Week 36)
|
|
Grip strength
Time Frame: II Group: pre-intervention (Week 1), post-intervention (Week 12), post-follow-up (Week 24); DI Group: first pre-intervention (Week 1), second pre-intervention (Week 12), post-intervention (Week 24), post-follow-up (Week 36)
|
Grip strength, as a surrogate marker of overall muscle strength, measured using a Martin vigorimater (kPa)
|
II Group: pre-intervention (Week 1), post-intervention (Week 12), post-follow-up (Week 24); DI Group: first pre-intervention (Week 1), second pre-intervention (Week 12), post-intervention (Week 24), post-follow-up (Week 36)
|
|
5x Sit to Stand Test
Time Frame: II Group: pre-intervention (Week 1), post-intervention (Week 12), post-follow-up (Week 24); DI Group: first pre-intervention (Week 1), second pre-intervention (Week 12), post-intervention (Week 24), post-follow-up (Week 36)
|
General functional measure of lower body strength, measured in seconds using a stop watch, performed as part of the Short Physical Performance Battery.
|
II Group: pre-intervention (Week 1), post-intervention (Week 12), post-follow-up (Week 24); DI Group: first pre-intervention (Week 1), second pre-intervention (Week 12), post-intervention (Week 24), post-follow-up (Week 36)
|
|
Modified Clinical Test of Sensory lnteraction and Balance
Time Frame: II Group: pre-intervention (Week 1), post-intervention (Week 12), post-follow-up (Week 24); DI Group: first pre-intervention (Week 1), second pre-intervention (Week 12), post-intervention (Week 24), post-follow-up (Week 36)
|
Assesses balance under four test conditions.
Time to perform each task is measured in seconds with a stopwatch, results range from not being able to perform a task to maximal task time of 30 seconds.
Postural sway will be measured during each task with the APDM system (measured in angle, m/s2, Hz or m2/s4, depending on paramter)
|
II Group: pre-intervention (Week 1), post-intervention (Week 12), post-follow-up (Week 24); DI Group: first pre-intervention (Week 1), second pre-intervention (Week 12), post-intervention (Week 24), post-follow-up (Week 36)
|
|
Falls
Time Frame: II Group: pre-intervention (Week 1), post-intervention (Week 12), post-follow-up (Week 24); DI Group: first pre-intervention (Week 1), second pre-intervention (Week 12), post-intervention (Week 24), and monthly throughout the trial duration for II and DI
|
Fall incidence will be documented from the pre-intervention assessment until the end of the follow-up period via monthly diaries completed by study participants as well as via monthly phone calls with the study team.
|
II Group: pre-intervention (Week 1), post-intervention (Week 12), post-follow-up (Week 24); DI Group: first pre-intervention (Week 1), second pre-intervention (Week 12), post-intervention (Week 24), and monthly throughout the trial duration for II and DI
|
|
Fear of falling
Time Frame: II Group: pre-intervention (Week 1), post-intervention (Week 12), post-follow-up (Week 24); DI Group: first pre-intervention (Week 1), second pre-intervention (Week 12), post-intervention (Week 24), post-follow-up (Week 36)
|
Self-reported using the Falls Efficacy Scale-lnternational version (FES-I) questionnaire (scores range from 1 to 64 points, higher point scores reflect greater subjective fear of falling), as well as binary responses (yes/no) of participants at each clinical visit
|
II Group: pre-intervention (Week 1), post-intervention (Week 12), post-follow-up (Week 24); DI Group: first pre-intervention (Week 1), second pre-intervention (Week 12), post-intervention (Week 24), post-follow-up (Week 36)
|
|
Montreal Cognitive Assessment test
Time Frame: II Group: pre-intervention (Week 1), post-intervention (Week 12), post-follow-up (Week 24); DI Group: first pre-intervention (Week 1), second pre-intervention (Week 12), post-intervention (Week 24), post-follow-up (Week 36)
|
Standardized test of general cognition, administered by trained site staff.
Scores range from 0 to 30 points, higher point scores reflect better cognition
|
II Group: pre-intervention (Week 1), post-intervention (Week 12), post-follow-up (Week 24); DI Group: first pre-intervention (Week 1), second pre-intervention (Week 12), post-intervention (Week 24), post-follow-up (Week 36)
|
|
Short Form-36, version 2, acute recall assessment of health-related quality of life
Time Frame: II Group: pre-intervention (Week 1), post-intervention (Week 12), post-follow-up (Week 24); DI Group: first pre-intervention (Week 1), second pre-intervention (Week 12), post-intervention (Week 24), post-follow-up (Week 36)
|
This self-report questionnaire is a reliable and valid tool for measuring health-related quality of life.
It consists of 36 questions (acute recall = previous week) reflecting eight domains of health and provides eight scaled scores, which are the weighted sums of the questions in each respective domain.
Each scale is directly transformed into a score of 0 to 100 points on the assumption that each question carries equal weight.
Lower scores are associated with greater disability and lower quality of life.
|
II Group: pre-intervention (Week 1), post-intervention (Week 12), post-follow-up (Week 24); DI Group: first pre-intervention (Week 1), second pre-intervention (Week 12), post-intervention (Week 24), post-follow-up (Week 36)
|
|
lntervention course attendance
Time Frame: At each course lesson (twice weekly throughout the 12 week intervention period) for the II and the DI group
|
Number of intervention courses from maximum 24 that each participant attends, as a marker of intervention adherence, will be documented by course instructors at each class
|
At each course lesson (twice weekly throughout the 12 week intervention period) for the II and the DI group
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Stephanie A. Bridenbaugh, M.D., University Department of Geriatric Medicine FELIX PLATTER
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 29, 2021
Primary Completion (Actual)
January 20, 2022
Study Completion (Actual)
January 20, 2022
Study Registration Dates
First Submitted
April 9, 2021
First Submitted That Met QC Criteria
April 22, 2021
First Posted (Actual)
April 27, 2021
Study Record Updates
Last Update Posted (Actual)
February 1, 2022
Last Update Submitted That Met QC Criteria
January 31, 2022
Last Verified
July 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BASEC ID 2018-00067
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy Aging
-
Florida Institute for Human and Machine CognitionNot yet recruitingAging | Healthy Aging | Aging WellUnited States
-
University of CopenhagenRecruitingAging | Healthy Aging | Aging FrailtyDenmark
-
Centre Hospitalier Universitaire de NiceNot yet recruitingAging | Aging, HealthyFrance
-
Arizona State UniversityActive, not recruiting
-
San Diego State UniversityCompleted
-
Lithuanian Sports UniversityCompletedAging | Healthy AgingLithuania
-
Beijing HospitalBGI-ShenzhenCompletedAging | Healthy Aging
-
Synbiotic HealthMusB ResearchRecruitingHealthy Aging | Anti AgingUnited States
-
Research Centre for Natural SciencesSemmelweis University; HUN-REN Institute of Experimental MedicineActive, not recruitingHealthy Aging | Neurocognitive AgingHungary
-
Northumbria UniversityUniversity of East AngliaSuspendedSleep | Aging | Healthy AgingUnited Kingdom
Clinical Trials on Power Centering for Seniors intervention
-
National Taipei University of Nursing and Health...Recruiting
-
Fraser HealthCompleted
-
National Taiwan University HospitalCompleted
-
Johns Hopkins UniversityCompletedMild Cognitive Impairment | Probable Alzheimer's DiseaseUnited States
-
Oswaldo Cruz FoundationMontefiore Medical CenterUnknown
-
University of DelawareCompletedObesity | Intellectual Disability | ExerciseUnited States
-
Seton Hall UniversityUnknown
-
University of North Carolina, Chapel HillCenters for Disease Control and PreventionCompletedHIV InfectionsUnited States
-
Norwegian Institute of Public HealthCompletedMental Health Wellness 1 | Mental Stress | Mental DepressionNorway
-
Seton Hall UniversityNot yet recruiting