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

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.

Study Overview

• Status: Completed
• Conditions: Exercise; Disabled Persons
• Intervention / Treatment: Other: Physical training

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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark, 9220
    • Department of Physiotherapy, University College of Northern Jutland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body mass index	weight (kg)/height (m) x height (m)	Through study completion, an average of 8 weeks
Blood pressure	Diastolic pressure (mmHg) Systolic pressure (mmHg)	Through study completion, an average of 8 weeks
Completed chair stands	Number of completed chair stands	Through study completion, an average of 8 weeks
Aastrand test	Bike test to measure the physical fitness.	Through study completion, an average of 8 weeks
Waist circumference	Measured in cm	Through study completion, an average of 8 weeks
Physical activity	Number of steps and active minutes	During test session - 2-3 days

Collaborators and Investigators

• Sponsor: University College of Northern Denmark
• Collaborators: TRYG Foundation
• Investigators: Study Director: Dorte Drachmann, Msc, University College of Northern Jutland, Denmark. Department of Physiotherapy

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2018
• Primary Completion (Actual): May 31, 2018
• Study Completion (Actual): May 31, 2018

Study Registration Dates

• First Submitted: March 26, 2019
• First Submitted That Met QC Criteria: April 1, 2019
• First Posted (Actual): April 2, 2019

Study Record Updates

• Last Update Posted (Actual): April 2, 2019
• Last Update Submitted That Met QC Criteria: April 1, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: FOU-UU-2018-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No