Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Quality Assessment of a Training Period for Physical and Mentally Disabled People

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03898492
Recruitment Status : Completed
First Posted : April 2, 2019
Last Update Posted : April 2, 2019
Sponsor:
Collaborator:
TRYG Foundation
Information provided by (Responsible Party):
University College of Northern Denmark

Brief Summary:
The aim of the study was to evaluate the effect of a 8 week training period compared with control group in physical and mentally disabled adults. The effect was evaluated in relation to their physical status. Furthermore, physical activity was measured using steps and active minutes.

Condition or disease Intervention/treatment Phase
Disabled Persons Exercise Other: Physical training Not Applicable

Detailed Description:

This study aimed at making a quality assessment of a 8 week training period for adults with physical and mental disabilities. A control group was added to compare the effect of the training with no training. Before the training period the participants were tested in relation to their physical status: weight, height, fat%, blood pressure, Aastrand test, chair stand test and waist circumference. In addition to this, the participants were instructed to wear an accelerometer to measure step and active minutes for 2-3 days a work.

The staff at the day center, where the participants works in daytime, were responsible for the physical training 2 times/week for 8 weeks. The training was an hour of combined aerobic, strength, balance and flexibility training.

The participants were tested after the training period using the same test-protocol as before.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: One intervention group and one control group
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Quality Assessment of a Training Period for Physical and Mentally Disabled People
Actual Study Start Date : January 3, 2018
Actual Primary Completion Date : May 31, 2018
Actual Study Completion Date : May 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Intervention
The participants in this group participated in exercise two times/week for 8 weeks
Other: Physical training
Training two times/week for an hour each time in 8 weeks. The training included strength training, aerobic training, balance training and flexibility training. The training was modified to the participants and initiated by the staff at the center.

No Intervention: Control
The participants in the control group were instructed to maintain their daily routines.



Primary Outcome Measures :
  1. Body mass index [ Time Frame: Through study completion, an average of 8 weeks ]
    weight (kg)/height (m) x height (m)

  2. Blood pressure [ Time Frame: Through study completion, an average of 8 weeks ]
    Diastolic pressure (mmHg) Systolic pressure (mmHg)

  3. Completed chair stands [ Time Frame: Through study completion, an average of 8 weeks ]
    Number of completed chair stands

  4. Aastrand test [ Time Frame: Through study completion, an average of 8 weeks ]
    Bike test to measure the physical fitness.

  5. Waist circumference [ Time Frame: Through study completion, an average of 8 weeks ]
    Measured in cm

  6. Physical activity [ Time Frame: During test session - 2-3 days ]
    Number of steps and active minutes



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • User of the centers included in the study
  • Being able to stand alone
  • Being able to use an exercise bike
  • Being able to understand danish

Exclusion Criteria:

  • Pregnancy
  • Pacemaker
  • Not being able to stand up by themselves

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03898492


Locations
Layout table for location information
Denmark
Department of Physiotherapy, University College of Northern Jutland
Aalborg, Denmark, 9220
Sponsors and Collaborators
University College of Northern Denmark
TRYG Foundation
Investigators
Layout table for investigator information
Study Director: Dorte Drachmann, Msc University College of Northern Jutland, Denmark. Department of Physiotherapy

Layout table for additonal information
Responsible Party: University College of Northern Denmark
ClinicalTrials.gov Identifier: NCT03898492     History of Changes
Other Study ID Numbers: FOU-UU-2018-001
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: March 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No