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Completed

NCT Number: NCT04861831

Power Centering for Seniors

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.

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Key information

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Department of Geriatric Medicine FELIX PLATTER

Basel, 4055, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Power Centering for Seniors intervention

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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

  5. 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

  6. 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

  7. 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.

  8. 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.

  9. 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.

  10. 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

  11. 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.

  12. 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.

  13. 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

  14. 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.

  15. 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)

  16. 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.

  17. 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)

  18. 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.

  19. 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

  20. 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

  21. 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.

  22. 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

Sponsors and collaborators

Lead sponsor

University Department of Geriatric Medicine FELIX PLATTER

Other

Registry information

Official study title

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

Acronym: PCS

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 27, 2021
Registry last updated
Feb 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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