Clinical trial NCT04861831: Power Centering for Seniors
Official title: Power Centering for Seniors: A Multimodal Intervention to Improve Mobility and Quality of Life in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Aging
Mobility Limitation
Walking, Difficulty
Keywords: Elderly
Walking speed
Gait
Falls
Quality of life
Independent living
Gait analysis
Physical functional performance
Montral Cognitive Assessment
Multimodal exercise
Exercise movement techniques
Muscle strength
Postural balance
Tai chi
Qi gong
Lead sponsor: University Department of Geriatric Medicine FELIX PLATTER
Sponsor class: OTHER
First posted: 2021-04-27
Enrollment: 63
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This delayed intervention trial begins as a parallel group design with the Delayed Intervention (Dl) group serving as a control arm comparison for the Immediate Intervention (II) group. There is no control intervention. The ll and the Dl groups will be assessed pre-intervention. After the 12-week intervention for the II group, resp. the waiting period for the DI group, the lI group will undergo their post-intervention assessment. At that time, the Dl group will undergo their 2nd pre-intervention assessment to document any change in baseline measures that may have occurred. No significant changes are expected, so that at the end of the trial, data from the ll and the Dl groups can be pooled to provide results on the overall changes in outcome measures for all participants post- versus pre-intervention. After the 2nd pre-intervention assessment, the Dl group will have their intervention, post-intervention assessment, follow-up period and final assessment, as with the II group.
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Gait speed
timeFrame: 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 outcomes:
measure: Cadence
timeFrame: 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)
measure: Base of support
timeFrame: 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)
measure: Step width variability
timeFrame: 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)
measure: Single support time
timeFrame: 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)
measure: Double support time
timeFrame: 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)
measure: Stride time
timeFrame: 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)
measure: Stride time variability
timeFrame: 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)
measure: Swing time
timeFrame: 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)
measure: Swing time variability
timeFrame: 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)
measure: Timed Up and Go Test
timeFrame: 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)
measure: Timed Up and Go Test, imagined
timeFrame: 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)
measure: Short Physical Performance Battery
timeFrame: 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)
measure: Continuous Scale of Physical Functional Performance Test
timeFrame: 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)
measure: Physical Activity Scale for the Elderly
timeFrame: 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)
measure: Grip strength
timeFrame: 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)
measure: 5x Sit to Stand Test
timeFrame: 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)
measure: Modified Clinical Test of Sensory lnteraction and Balance
timeFrame: 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)
measure: Falls
timeFrame: 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
measure: Fear of falling
timeFrame: 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)
measure: Montreal Cognitive Assessment test
timeFrame: 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)
measure: Short Form-36, version 2, acute recall assessment of health-related quality of life
timeFrame: 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)
measure: lntervention course attendance
timeFrame: At each course lesson (twice weekly throughout the 12 week intervention period) for the II and the DI group
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Department of Geriatric Medicine FELIX PLATTER
Study officials:
affiliation: University Department of Geriatric Medicine FELIX PLATTER
name: Stephanie A. Bridenbaugh, M.D.
role: PRINCIPAL_INVESTIGATOR
References: