Power Centering for Seniors

Healthy Aging Clinical Trial

— PCS  

Official title:

Power Centering for Seniors: A Multimodal Intervention to Improve Mobility and Quality of Life in Older Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04861831
• Other study ID #: BASEC ID 2018-00067
• Status: Completed
• Phase: N/A
• Start date: January 29, 2021
• Est. completion date: January 20, 2022

Study information

• Verified date: July 2021
• Source: University Department of Geriatric Medicine FELIX PLATTER
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: January 20, 2022
• Est. primary completion date: January 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy Aging
• Mobility Limitation
• Walking, Difficulty

Intervention

Other:
• Power Centering for Seniors 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.

Locations

Country	Name	City	State
Switzerland	University Department of Geriatric Medicine FELIX PLATTER	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Department of Geriatric Medicine FELIX PLATTER

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gait speed	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	Cadence	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)
Secondary	Base of support	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)
Secondary	Step width variability	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)
Secondary	Single support time	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)
Secondary	Double support time	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)
Secondary	Stride time	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)
Secondary	Stride time variability	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)
Secondary	Swing time	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)
Secondary	Swing time variability	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)
Secondary	Timed Up and Go Test	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)
Secondary	Timed Up and Go Test, imagined	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)
Secondary	Short Physical Performance Battery	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)
Secondary	Continuous Scale of Physical Functional Performance Test	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)
Secondary	Physical Activity Scale for the Elderly	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)
Secondary	Grip strength	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)
Secondary	5x Sit to Stand Test	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)
Secondary	Modified Clinical Test of Sensory lnteraction and Balance	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)
Secondary	Falls	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
Secondary	Fear of falling	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)
Secondary	Montreal Cognitive Assessment test	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)
Secondary	Short Form-36, version 2, acute recall assessment of health-related quality of life	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)
Secondary	lntervention course attendance	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

External Links

•   Power Centering for Seniors website of the Legacy of Wisdom Swiss Association
•   study site website and trial description (in German)