Training Effects Following Resection Surgery in Patients With Lung Cancer

NCT01771796 | Completed

• 1 other identifier: PSM/RHB/CR/12
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine the potential benefits resulting from a specific training on exercise tolerance and muscle function at the medium and long-time, as well as study its effects on plasmatic mediators (sMICA, IGF-I and IGFBP-3) in patients with lung cancer following resection surgery.

Conditions

Lung Cancer

Keywords

Exercise; lung cancer; aerobic training, resistance training; respiratory muscle training

Outcome Measures

Primary Outcomes (1)

• Peak oxygen uptake (VO2peak) determined by a cardiopulmonary effort test (CPET)

  VO2peak is determined by a standardised incremental exercise test. Subjects are instructed to pedal in an electrically braked cycloergometer and are encouraged to continue until they are not able to sustain the target frequency (55-65 rpm). Loads are increased by 25 watts every 2 minutes. Different ventilatory, cardiovascular, metabolic and oxygenation variables are monitored throughout the test using a calibrated exercise system, a standard electrocardiograph, an automatic sphygmomanometer and a finger probe connected to the aforementioned digital recorder. Normal values published by Jones et al are used as the reference for physiological parameters, except for the maximum heart rate which was calculated from a standard equation published by Wassermann et al.

  3 times a week during 8 weeks

Secondary Outcomes (3)

• Other effort parameters determined by the CPET

  Before training (8-10 weeks post-surgery) and after (8-week training, 16-18 weeks post-surgery)

• Peripheral muscle strength

  Before training (8-10 weeks post-surgery) and after (8-week training, 16-18 weeks post-surgery)

• Plasmatic levels of sMICA, IGF-I, IGFBP-3.

  Before training (8-10 weeks post-surgery) and after (8-week training, 16-18 weeks post-surgery)

Study Arms (2)

Aerobic and muscle resistance training

EXPERIMENTAL

Behavioral: Aerobic and muscle resistance training

Usual care group

NO INTERVENTION

All patients (intervention and usual care group) are patients with lung cancer who underwent a resection surgery.

Interventions

Aerobic and muscle resistance training BEHAVIORAL

After having been allocated randomly to one of the two groups, patients of Intervention Group are encouraged to follow a training program (aerobic and endurance muscle training) during 8 weeks.

Aerobic and muscle resistance training

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) age under 80 years.
• \) patients with lung cancer stage I or II with surgery indication.
• \) ability to understand and accept the trial procedures and to sign an informed consent.

You may not qualify if:

• \) Serious cardiovascular, neuromuscular or metabolic conditions that could interfere with the results and/or interfere with the measurements.
• \) complementary cancer treatment pre-or post-surgery.
• \) treatment with drugs with potential effect on muscle structure and function (steroids, anabolic steroids, thyroid hormones and immunosuppressive).
• \) cognitive or language barriers that impede the realization of the objective of the study and / or collaboration in the exercise program.

Sponsors & Collaborators

• Parc de Salut Mar: lead
• Hospital de Sant Pau: collaborator

Study Sites (2)

1) Physical Medicine and Rehabilitation Dpt. Parc de Salut Mar.

Barcelona, Barcelona, 08003, Spain

Location

2) Respiratory Medicine Dpt. Hospital de la Santa Creu i Sant Pau.

Barcelona, Barcelona, 08025, Spain

Location

MeSH Terms

Conditions

Lung Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: January 10, 2013
• First Posted: January 18, 2013
• Study Start: November 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: February 1, 2016
• Last Updated: February 17, 2016

Record last verified: 2016-02

Locations

ES (2)