NCT04861831

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

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

January 29, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 27, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2022

Completed
Last Updated

February 1, 2022

Status Verified

July 1, 2021

Enrollment Period

12 months

First QC Date

April 9, 2021

Last Update Submit

January 31, 2022

Conditions

Keywords

ElderlyWalking speedGaitFallsQuality of lifeIndependent livingGait analysisPhysical functional performanceMontral Cognitive AssessmentMultimodal exerciseExercise movement techniquesMuscle strengthPostural balanceTai chiQi gong

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (22)

  • Cadence

    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

    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

    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

    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

    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)

  • +17 more secondary outcomes

Study Arms (2)

Immediate PCS Intervention

EXPERIMENTAL

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.

Other: Power Centering for Seniors intervention

Delayed PCS Intervention

EXPERIMENTAL

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.

Other: Power Centering for Seniors intervention

Interventions

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.

Delayed PCS InterventionImmediate PCS Intervention

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Department of Geriatric Medicine FELIX PLATTER

Basel, 4055, Switzerland

Location

Related Publications (1)

  • Rossler R, Birrer M, Haslbauer A, Goldfarb J, De Spiegeleer A, Hardi I, Kressig RW. Efficacy of the power centering for seniors intervention on physical functional performance in older community-dwelling adults: a secondary analysis of a randomised controlled trial. Sci Rep. 2025 Aug 7;15(1):28908. doi: 10.1038/s41598-025-13404-6.

Related Links

MeSH Terms

Conditions

Mobility Limitation

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Stephanie A. Bridenbaugh, M.D.

    University Department of Geriatric Medicine FELIX PLATTER

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2021

First Posted

April 27, 2021

Study Start

January 29, 2021

Primary Completion

January 20, 2022

Study Completion

January 20, 2022

Last Updated

February 1, 2022

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations