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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	German Clinical Trials Register
Last refreshed on:	8 April 2024
Main ID:	DRKS00005048
Date of registration:	30/07/2014
Prospective Registration:	No
Primary sponsor:	Klinik für Palliativmedizin, Universitätsklinikum Freiburg
Public title:	Training intervention with Palliative Patients (TiPP) - pilot study
Scientific title:	Training intervention with Palliative Patients (TiPP) - pilot study - TiPP
Date of first enrolment:	11/12/2013
Target sample size:	25
Recruitment status:	Recruiting stopped after recruiting started
URL:	http://drks.de/search/en/trial/DRKS00005048
Study type:	interventional
Study design:	Allocation: N/A: single arm study; Masking: Open (masking not used); Control: uncontrolled; Assignment: single; Study design purpose: treatment
Phase:	N/A

Countries of recruitment
Germany

Contacts

Name:	Gerhild Becker
Address:	Robert-Koch-Straße 3 79106 Freiburg Germany
Telephone:	+49 761 270-95412
Email:	gerhild.becker@uniklinik-freiburg.de
Affiliation:	Klinik für Palliativmedizin, Universitätsklinikum Freiburg

Name:	Gerhild Becker
Address:	Robert-Koch-Straße 3 79106 Freiburg Germany
Telephone:	+49 761 270-95412
Email:	gerhild.becker@uniklinik-freiburg.de
Affiliation:	Klinik für Palliativmedizin, Universitätsklinikum Freiburg

Key inclusion & exclusion criteria

Inclusion criteria: Inclusion criteria of palliative care patients:
- palliative patients
- = 18 years
- life expectancy 6-12 months
- ECOG: = 2
- numerical rating scale for pain = 3
- adequate cognitive status

Exclusion criteria: Exclusion criteria:
- neurological or orthopaedic diseases
- osseous metastases
- heart diseases: NYHA III-IV
- hypertensive emergency last 12 months
- bleeding tendency
- dyspnea during movement (VRS = 2)

Age minimum: 18 Years
Age maximum: None
Gender: All

Health Condition(s) or Problem(s) studied

All diseases needing palliative care.

Intervention(s)

Group 1: The exercise program consists of a strength- (KE) and a balance-endurance-flexibility-training (GABE) and has a length of 6 weeks. All exercises should be executed not exceeding 13-14 point on Borg Scale (range 6-20).
KE is performed three times per week (35 minutes) and GABE two times (25-30 minutes).

Primary Outcome(s)

De Morton Mobility Index (DEMMI); questionnaire: mobility; measurement after 3 and 6 weeks ///
Caregiver:
IRES-24; questionnaire: health status and physical functioning; measurement after 3 and 6 weeks

Secondary Outcome(s)

All measurements on week 3 and 6:
Patients:
- QLQ-C30; questionnaire: quality of life
- balance path length for Rombergstand via force plate
- 6 Minute Walk Test (6MWT); distance walked
- Barthel Index (BI); questionnaire: activities of daily living
- Five Times Sit to Stand Test (FTSS) on a force plate; repetitions
- Hand grip strength; Newton
- Qualitative interviews after intervention (nur bei T2)
/// Caregiver: - balance path length for Rombergstand via force plate
- Hand grip strength; Newton
- 30s chair stand test; repetitions

Secondary ID(s)

Source(s) of Monetary Support

Klinik für Palliativmedizin

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date: 25/06/2013
Contact:

ekfr.mpg@uniklinik-freiburg.de

Ethik-Kommission der Albert-Ludwigs-Universität Freiburg

+49-761-27072600

ekfr.mpg@uniklinik-freiburg.de

Results

Results available:	Yes
Date Posted:	02/10/2015
Date Completed:	31/01/2014
URL:	http://drks.de/search/en/trial/DRKS00005048#studyResults

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