NCT03782922

Brief Summary

In this study, i.e. randomized controlled trial, the effect of an exercise training program on mental and anatomical characteristics of physiotherapy students is measured.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Dec 2018

Shorter than P25 for not_applicable healthy

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

December 1, 2018

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

December 5, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 20, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
Last Updated

April 11, 2019

Status Verified

December 1, 2018

Enrollment Period

3 months

First QC Date

December 5, 2018

Last Update Submit

April 9, 2019

Conditions

Keywords

exerciseanatomicalmentaltraining program

Outcome Measures

Primary Outcomes (5)

  • d2-R-Test

    Mental

    Change from baseline attention and concentration at 4 weeks (objective)

  • AKA-Questionnaire (attention, concentration, learning ability)

    Participants fill out a questionnaire about attention, concentration and learning ability. There are five possible answers for each item from 1 (completely disagree) to 5 (completely agree).

    Change from baseline attention and concentration at 4 weeks (subjective)

  • M360 - physiological parameter of the spine

    Participants are measured in different positions (upright, flexion, extension; measured in degrees) to assess position, stability and mobility of the spine. The M360 will be guided along the back and the data will be collected electronically (https://www.idiag.ch/idiag-m360/).

    Change from baseline position and mobility of the spine at 4 weeks

  • Pain (Visual Analogue Scale)

    Participants can use this scale to classify their pain from "No pain" and "Maximum pain imaginable" by means of a slider.

    Change from baseline pain (back) at 4 weeks

  • FAW-Questionnaire (Actual physical well-being)

    Participants fill out a questionnaire with 58 questions. Each question has five possible answers from 0 (completely disagree) to 4 (completely agree). The highter the score the better the actual physical well-being.

    Change from baseline physical well-being at 4 weeks

Study Arms (2)

Exercise Training Program

EXPERIMENTAL
Other: Exercise Training Program

Control

NO INTERVENTION

Interventions

10min of coordination and strength training (2-3x per week) during 2-6 weeks

Exercise Training Program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age ≥18
  • signed consent
  • THIM student
  • good health status

You may not qualify if:

  • alcohol
  • drugs
  • smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

THIM University of Applied Sciences

Landquart, 7302, Switzerland

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2018

First Posted

December 20, 2018

Study Start

December 1, 2018

Primary Completion

February 28, 2019

Study Completion

March 31, 2019

Last Updated

April 11, 2019

Record last verified: 2018-12

Locations