Physical Function and Activities of Daily Living in Cancer Patients During Chemotherapy

Advanced Gastrointestinal Cancer Clinical Trial

Official title:

Physical Function and Activities of Daily Living in Cancer Patients During Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02677129
• Other study ID #: SPM2015-003
• Status: Completed
• Phase: N/A
• First received: February 2, 2016
• Last updated: April 11, 2017
• Start date: August 2014
• Est. completion date: November 2016

Study information

• Verified date: April 2017
• Source: Goethe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is a randomized controlled trial with the aim to examine the feasibility and the effects of a home-based exercise intervention program on activities of daily living (ADL) in patients with advanced gastrointestinal cancer undergoing chemotherapeutic treatment. Further outcomes include functional and body status, quality of life, body composition, and chemotherapy completion rate. Study participants will be randomized to an exercise intervention group or a wait-list control group

Description:

A randomised longitudinal study. A total of 44 gastrointestinal cancer patients before their first-line chemotherapy are recruited and randomised into one of two treatment groups A: Home based- physical activity or B: wait-control. The intervention period is 12 weeks. Primary outcome are the ADLs (iADL 1-8; FIM 1-7).Secondary outcomes are the physical activity, quality of life, peripheral polyneuropathy, chemotherapy regimen, gait speed, postural stability, maximal isometric voluntary force of the upper extremity, Maximal isometric voluntary force (MIVF) and strength endurance of the lower extremity, nutritional state, body composition and perceive functional ability. All measurements are standardized and are performed before chemotherapy, after 2 cycles of chemotherapy (4-6weeks) and after 12 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: November 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Histologically classified gastrointestinal cancer

• UICC III-IV

• Prior to (planned) first-line chemotherapy (curative und palliative)

• =50 years

Exclusion Criteria:

• ECOG > 2

• Systemic diseases (MS, ALS)

• disorders (neurological, skeletal, muscular, mental or cognitive) or drug use (irrespective of the cancer therapy) that may affect gait, balance or muscular strength

• chronic infection, uncontrolled hypertension (diastolic pressure over 95 mmHg)

• vestibulopathies

• uncorrected visual deficits

Related Conditions & MeSH terms

• Advanced Gastrointestinal Cancer
• Gastrointestinal Neoplasms

Intervention

Other:
• home-based exercise intervention
Endurance training (moderate intensity; walking), 3-5 times per week Patients will receive exercise counselling how to realize the planned intervention home-based. Further, they will be asked to fill out an exercise log. The study team will periodically review adherence to the intervention and identify problems.

Locations

Country	Name	City	State
Germany	Agaplesion Markus Hospital	Frankfurt

Sponsors (2)

Lead Sponsor	Collaborator
Goethe University	Agaplesion Markus Krankenhaus gGmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short Physical Performance Battery	Short battery of physical performance tests used to assess lower extremity function. Balance, gait, strength, and endurance are evaluated.	Change between the first 12 weeks of chemotherapy
Secondary	Daily physical activity	7 days accelerometry	3 times in the course of 12 weeks of chemotherapy
Secondary	Polyneuropathy	Measuring the sensibility with a Rydel-Seiffer tuning fork	3 times in the course of 12 weeks of chemotherapy
Secondary	Gait speed	usual gait speed (km/h) on a capacitive force-measuring platform (30Hz) WinFDM v0.0.41® (Zebris© GmbH, Isny, Germany)	3 times in the course of 12 weeks of chemotherapy
Secondary	Postural sway	balance measuring (COP) on a capacitive force-measuring platform (30Hz) WinFDM v0.0.41® (Zebris© GmbH, Isny, Germany)	3 times in the course of 12 weeks of chemotherapy
Secondary	Maximum isometric voluntary force of the upper extremity	JAMAR Hand Dynamometer	3 times in the course of 12 weeks of chemotherapy
Secondary	Maximum isometric voluntary force of the lower extremity	The maximal isometric voluntary force (MIVF) of the randomly chosen knee extensor is measured with a strain gauge force transducer (ASYS®; SPOREG; 100 Hz) in a standardised seating position (predefined knee and hip angle = 90°).	3 times in the course of 12 weeks of chemotherapy
Secondary	Muscular endurance (Chair-Rise Test)	For the five times sit to stand test patients start in a standard position sitting on a chair that is placed next to the wall with the arms folded across their chest. They are asked to stand up from a chair to a full standing position and sit down again keeping the arms crossed for five times as quickly as possible.	3 times in the course of 12 weeks of chemotherapy
Secondary	Quality of life	European Organisation for Research and Treatment of Cancer (EORTC_QLQ-C30)	3 times in the course of 12 weeks of chemotherapy
Secondary	Quality of life	The 36-Items Short Form Health Survey (SF-36)	3 times in the course of 12 weeks of chemotherapy
Secondary	Nutrition Assessment	Mini Nutritional Assessment (MNA)	3 times in the course of 12 weeks of chemotherapy
Secondary	Phase angle	multifrequent bioelectrical impedance analysis (DATA-Input) measuring the phase angle	3 times in the course of 12 weeks of chemotherapy
Secondary	Body cell mass	multifrequent bioelectrical impedance analysis (DATA-Input) measuring the body cell mass (BCM)	3 times in the course of 12 weeks of chemotherapy
Secondary	Fat mass	multifrequent bioelectrical impedance analysis (DATA-Input) measuring the fat mass	3 times in the course of 12 weeks of chemotherapy
Secondary	Perceived functional ability	perceived functional ability scale	3 times in the course of 12 weeks of chemotherapy
Secondary	Activities of daily living	Functional Independence Measurement (FIM) Questionnaire	Change between the first 12 weeks of chemotherapy
Secondary	Activities of daily living	- instrumental Activity of Daily Living (iADL)	Change between the first 12 weeks of chemotherapy