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OpenTrials
Completed

NCT Number: NCT02512874

Does Pulmonary Rehabilitation Improve Frailty?

Frailty is a state of health with predisposition to adverse events, morbidity and mortality. Frailty consists of weakness, slowness, low physical activity, exhaustion, and wasting. Frailty is associated with increased hospitalizations and death in lung disease. It is unknown if pulmonary rehabilitation will improve frailty markers.

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Key information

Conditions

Disease, Pulmonary Lung Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

Individuals referred to pulmonary rehabilitation will be examined for frailty markers. After completing pulmonary rehabilitation, the same tests will be performed. The effects of pulmonary rehabilitation will be examined.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Referred for pulmonary rehabilitation
  • consenting to research

Exclusion criteria

-Under 18 years of age

Treatment and study plan

Pulmonary Rehabilitation

Other

Measures of frailty taken before and after pulmonary rehabilitation.

Dynamometer

Device

Grip Test

DEXA

Radiation

Body Composition Testing

Gait Speed Test

Other

15 foot walk test

Activity monitor

Device

Measures energy expenditure and activity

questionnaires

Other

Health-related questionnaires measuring self-reported exhaustion, emotions and disease symptoms.

Primary outcomes

  1. Number of Participants With Frailty Phenotype at Baseline and 6 Months

    Time frame: Baseline, Six months

    Frailty phenotype is 3 or more of: slow gait speed, exhaustion, decreased hand grip strength, decreased activity level, or wasting. Grip strength parameters, gait speed, exhaustion per Fried et al. 2001. Wasting is defined as further decrease in fat free mass by body composition measurement using DEXA. Low physical activity would be activity monitor in lower quartile.

Secondary outcomes

  1. Wasting

    Time frame: after pulmonary rehabilation completion, appoximately 8 weeks

    DXA measurement of body mass index pre- and post- PR.

  2. Change in Strength

    Time frame: after completion of pulmonary rehab, approximately 8 weeks

    Change in Grip Strength as measured by hand dynamometer.

  3. Change in Gait Speed

    Time frame: pre and post pulmonary rehab, approximately 8 weeks

    gait speed test measured over 15 feet

  4. Improvement in Exhaustion

    Time frame: pre and post pulmonary rehab, approximately 8 weeks

    Self-reported exhaustion - measured by two questions in the Center for the Epidemiological Studies in Depression (CES-D) scale and reported as a dichotomous variable (exhausted or not exhausted).

  5. Change in Physical Activity Level

    Time frame: pre and post pulmonary rehab, approximately 8 weeks

    Measured by Body Media armband activity monitor using total energy expenditure divided by the resting metabolic rate

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Does Pulmonary Rehabilitation Improve Frailty in Chronic Lung Disease?

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jul 31, 2015
Registry last updated
Jun 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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