Active for Life: Chronic Obstructive Pulmonary Disease

NCT03201198 | Completed Results DMC

• 2 other identifiers: HUM00119545R01NR016093
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

Brief Summary

This study examines the effects of an exercise and behavioral program, called Active-Life, to promote physical activity in people with chronic obstructive pulmonary disease. A sedentary lifestyle is very common in older people with chronic disease and if this program is successful it will be used to promote physical activity and improve the health of people with chronic obstructive pulmonary disease.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

physical activity; Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (2)

• Time Spent in Physical Activity as Measured by Upright Time (Minutes Per Day) Monitored by ActivPal Monitor

  The primary dependent variables are the time spent in physical activity (PA) as measured by Upright time monitored in each of the five intervals of the study over a 15-month period. PA will be measured for 7 consecutive days at each measurement using the ActivPal monitor. Each subject must have at least 4 of 7 valid monitoring days in each monitored period. The monitored periods are: baseline (T1), immediate post-intervention (T2), 3-month follow-up post intervention (T3), 6 month follow-up (T4), 12 month follow-up period (T5)

  7 days of continuous activity monitoring w as monitored on each participants at each of five test periods (T1-T5)

• Time Spent in Sedentary Behavior

  The primary dependent variable are the time spent in sedentary activity as measured as Sedentary Activity (SA) time monitored in each of the five intervals of the study over a 15-month period. SA will be measured for 7 consecutive days at each interval using the ActivPal monitor. Each subject must have at least 4 of 7 valid monitoring days in each monitored period. The monitored periods are: baseline (T1), immediate post-intervention (T2), 3-month follow-up post intervention (T3), 6 month follow-up (T4), 12 month follow-up period (T5)

  7 days of continuous activity monitoring at each interval

Secondary Outcomes (1)

• Six-minute Walk Test

  Measured at baseline, end of 10 week intervention and at 3, 6, and 12 months after the completion of the 10 week intervention

Study Arms (2)

Active Life

EXPERIMENTAL

The Active Life intervention includes structured walking, functional circuit training, stretching and behavior/educational components.

Behavioral: Active Life

Chair exercises

SHAM COMPARATOR

The Chair exercise intervention includes chair exercises, behavioral relaxation and health education.

Behavioral: Chair exercises

Interventions

Active Life BEHAVIORAL

The Active Life intervention focuses on increasing light physical activity (LPA) with 18 sessions over 10 weeks. Each session starts with 20 minutes of walking followed by functional circuit training. The intensity of the exercises and the speed of execution are adjusted to attain a rating of perceived exertion equal to somewhat hard to hard at the end of each circuit. Sessions end with stretching the major muscle groups. Sessions include a behavioral component (self-efficacy enhancing or confidence building) and health education. Subjects are encouraged to increase their total PA by at least 60 minutes a day, focusing on LPA. After completion of the structured intervention subjects will receive 11 5-minute phone coaching sessions and two booster sessions over the next 12 months.

Active Life

Chair exercises BEHAVIORAL

Chair exercises focus on toning and stretching from a seated position with 18 sessions over 10 weeks. Each session includes 5 minutes of slow stretching, 20 minutes of faster paced exercises, 5 minutes of slower paced stretches, followed by 5-10 minutes of massage and imagery. Guided imagery is used to promote relaxation. Health education includes topics of interest to people with COPD such as basic lung physiology, pathophysiology of COPD, commonly used medications, breathing techniques, healthy eating and physical activity, relaxation, travel considerations, and energy conservation. After completion of the structured intervention subjects will receive 11 5-minute phone coaching sessions and two booster sessions over the next 12 months.

Chair exercises

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• No acute exacerbations or major illnesses requiring hospitalization in the last 8 weeks.
• No history of other major lung diseases as primary pulmonary problem, history of a recent heart attack or recent onset of chest pains with activity or increasing episodes of chest pain (unstable angina).
• No other health problems or mobility problems that limit physical activity.
• Sedentary (less than 30 minutes of moderate activity 3 days/week)

You may not qualify if:

• Acute exacerbations or major illnesses requiring hospitalization in the last 8 weeks.
• History of other major lung diseases as primary pulmonary problem, history of a recent heart attack or recent onset of chest pains with activity or increasing episodes of chest pain (unstable angina).
• Other health problems or mobility problems that limit physical activity.
• Participated in a structured exercise program or pulmonary rehabilitation within the last year.

Sponsors & Collaborators

• University of Michigan: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of Michigan School of Nursing

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Limitations and Caveats

Limitations include decreased recruitment in non-white populations. Attempts were made to recruit from minority groups but not successful.

Results Point of Contact

• Title: Dr. Janet Larson
• Organization: University of Michigan School of Nursing

janetlar@med.umich.edu

7346470126

Study Officials

• Janet L Larson, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Shaké Ketefian Collegiate Professor of Nursing

Study Record Dates

• First Submitted: January 4, 2017
• First Posted: June 28, 2017
• Study Start: July 27, 2017
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: April 17, 2024
• Results First Posted: April 17, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)