NCT06133894

Brief Summary

The general aim of the present study is to create and empirically evaluate (RCT trial) an online education and exercise program (called PERMANENTO) to help older adults to understand the wider consequences of being active and offer them easy to follow exercise program inspired by developmental kinesiology.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 13, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 6, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

3 months

First QC Date

November 6, 2023

Last Update Submit

November 14, 2023

Conditions

Keywords

preventionolder adultsfunctional statusfrailtysarcopeniaexerciseon-line programsustainability

Outcome Measures

Primary Outcomes (6)

  • Timed up-and go test

    Performance-based measure of functional mobility and balance in older adults.The test requires the participant to rise from a chair, walk 3.0 m at a comfortable pace to a mark placed on the floor, turn around at the 3.0 m mark, walk back to the starting point, and return to sitting in the chair. The test's score is the time it takes the subject takes to complete the test. Lower score is better result.

    Within a week prior the intervention and within a week after the intervention

  • Limits of stability on NeuroCom

    The Limits of Stability (LOS) test quantifies the maximum distance participant can lean own body (i.e. intentionally weight shift) in a given direction without losing balance, stepping, or reaching for assistance as would be required for function and gait. The scores for each parameter and movement direction are represented by a numeric value. Higher score is better result.

    Within a week prior the intervention and within a week after the intervention

  • The Sensory Organization Test on NeuroCom

    The Sensory Organization Test (SOT) objectively identifies abnormalities in the patient's use of the three sensory systems that contribute to postural control: somatosensory, visual, and vestibular. The scores summarize the overall function of the three systems and the ability to resolve conflicting sensory inputs. Scores range from 0 to 100 (higher score, better result). Composite score identifies the presence of a balance control problem. Scores range from 0 to 100 (higher score, better result).

    Within a week prior the intervention and within a week after the intervention

  • Body composition on InBody 720

    The multifrequency body composition analyser InBody720 analyses body composition via the method of bioelectrical impedance (DSM-BIA) for every part of the body using 6 different frequencies (1kHz, 5kHz, 50kHz, 250kHz, 500kHz, 1000kHz) in each one of the five parts of the body with the quadrupole 8-point tactile system. It provides wide range of outcomes (main focus on: Body fat mass - lower score, better result, Skeletal muscle mass - higher score, better result, Visceral Fat - lower score, better result).

    Within a week prior the intervention and within a week after the intervention

  • Handgrip strength on dynanometr

    Handgrip strength test is to measure the maximum isometric strength of the hand and forearm muscles. Participant is instructed to squeezes the dynamometer with maximum isometric effort, which is maintained for about 5 seconds. No other body movement is allowed. Higher score, better result.

    Within a week prior the intervention and within a week after the intervention

  • Perceived functional fitness and health status

    Measured by questions "In general, would you say your health is poor, fair, good, very good, or excellent?" and "In general, would you say your functional fitness is poor, fair, good, very good, or excellent?". Score are represented on 5-point scale: (1) Excellent, 2) Very Good, 3) Good, 4) Fair, or 5) Poor). Lower score, better result.

    Within a week prior the intervention and within a week after the intervention

Secondary Outcomes (1)

  • Long-term sustainability

    6 and 12 months after the end of the intervention

Study Arms (2)

Experimental group

EXPERIMENTAL

The experimental group was educated and instructed and agaged in a 12-week exercise program - 15 minutes 6 times per week of complex daily routines delivered via on-line platform.

Behavioral: Exercise program PERMANENTO inspired by developmental kinesiology

Contol group

NO INTERVENTION

The control group continued in regular daily activities and was offered the same intervention as the experimental group after the research trial.

Interventions

The intervention is based on activation of reflexive movement patterns which ensures the original reflexive control of strength, mobility and stability. After birth, we cannot control our body movements - they are reflexes "hard-wired" into our brains and vitally important for proper development of our body (muscular system, vestibular system, sensory system, cardiovascular system or digestive system) as well as our brain and nervous systems. During early childhood, everything becomes integrated and works perfectly according to the original design. But this design is slowly abandoned due to for example sedentary lifestyle and replaced by compensatory movement patterns that are making us weaker and defective with all the consequences that are becoming more severe as we age. The aim is restore the original design and improve posture and other crucial components of functional fitness and move better and more.

Experimental group

Eligibility Criteria

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

You may qualify if:

  • permanent residency in Prague
  • being at least 70 years of age or older
  • living independently at home

You may not qualify if:

  • significant mobility limitation
  • any health condition preventing from physical activity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre of Expertise oi Longevity and Long-term Care

Prague, 182 00, Czechia

Location

MeSH Terms

Conditions

FrailtySarcopeniaMotor Activity

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalSigns and SymptomsBehavior

Study Officials

  • Katerina Machacova

    Centre of Expertise in Longevity and Long-term care, Faculty of Humanities, Charles University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Single blinded study
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized controlled trial of volunteers over 70 years of age
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 6, 2023

First Posted

November 18, 2023

Study Start

February 13, 2023

Primary Completion

May 15, 2023

Study Completion

June 15, 2023

Last Updated

November 18, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations