- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06368128
Climbing Lifestyle Intervention for Modifying Physical Activity Behaviors: Pilot Study (CLIMB)
April 15, 2024 updated by: Megan C. Nelson, Northern Michigan University
Climbing Lifestyle Intervention for Modifying Physical Activity Behaviors (CLIMB): Pilot Study
The aim of this pilot study is to determine the effects of a 12-week indoor rock climbing training program on heart health, mental health, and behavioral health in generally healthy adults aged 18-35 years old who do not exercise.
Participants will learn to rock climb using ropes on an indoor rock climbing wall and participate in the training program 2-3 days per week for 60 minutes each session over 12 weeks.
Health outcomes will be measured at 4 time points over the course of the study (pre-intervention, 6-weeks/mid-intervention, 12-weeks/post-intervention, and 24-weeks post-intervention).
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
The purpose of this study is to determine the effects of a 12-week progressive, supervised indoor rock climbing intervention on physical, mental, and behavioral health outcomes in physically inactive adults.
This will be a pilot study used for informing a larger, randomized controlled trial.
Measurements include: cardiometabolic disease risk factors (e.g., blood pressure, fasting glucose and lipids, hemoglobin a1c), health-related components of physical fitness (e.g., cardiorespiratory fitness, muscular fitness, dynamic balance, body composition), health-related quality of life, and behavior change variables (e.g., attitudes toward physical activity, self-efficacy for exercise, objective physical activity and sedentary behavior).
The majority of rock climbing-related studies focus on enhancing performance in high-level climbing athletes and very little research has examined the specific impact of climbing physical activity on cardiovascular health parameters.
Indoor climbing has demonstrated to be an activity that is safe for many individuals and does not require a high level initial fitness to partake in the activity.
This study will engage generally healthy, physically inactive adults (aged 18-35 y) in an indoor rock climbing program 2 times per week for 60 minutes for the first 4 weeks and progressing to 3 times per week for 60 minutes for the last 8 weeks.
Participants will partake in top-rope style rock climbing and bouldering.
Data collection will occur over three visits to the School of Health and Human Performance Research Lab at four time points throughout the course of the study (baseline/pre-intervention, 6-weeks/mid-intervention, 12-weeks/post-intervention, 24-weeks post-intervention; total of 12 data collection visits).
Study Type
Interventional
Enrollment (Estimated)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lisa Eckert, PhD
- Phone Number: 906-227-1291
- Email: leckert@nmu.edu
Study Locations
-
-
Michigan
-
Marquette, Michigan, United States, 49855
- Recruiting
- Northern Michigan University
-
Contact:
- Lisa Eckert, PhD
- Phone Number: 906-227-1291
- Email: leckert@nmu.edu
-
Principal Investigator:
- Megan C Nelson, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Physically inactive
- Membership to Physical Education Instructional Facility at Northern Michigan University
- No/very little experience with rock climbing
- No diagnosed cardiovascular, metabolic, renal disease
- No current injury
Exclusion Criteria:
- Physically active
- Experience with rock climbing
- No current membership with Physical Education Instructional Facility at Northern Michigan University
- Pregnant and/or breastfeeding
- Diagnosis of cardiovascular disease, metabolic disease, renal disease
- Current or previous injury that would be exacerbated by rock climbing
- Other diagnosed conditions in which rock climbing would be contraindicated
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
Participants in the control arm will be asked to maintain their current lifestyle behaviors.
|
|
Experimental: Intervention
Participants in the intervention arm will be asked to partake in a 12-week progressive, supervised, indoor rock climbing training program.
|
Training will occur 2-3 days per week for 60 minutes; ratings of perceived exertion between 3-7 on a scale of 0-10 will be targeted for the desired intensity throughout the program.
Minutes of rock climbing will also be monitored to develop the progression strategy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fasting lipids
Time Frame: 0, 6, 12, 24 weeks
|
HDL-c; LDL-c; total cholesterol, triglycerides measured via capillary blood sample and point-of-care testing
|
0, 6, 12, 24 weeks
|
Fasting glucose
Time Frame: 0, 6, 12, 24 weeks
|
glucose (mg/dL) measured via capillary blood sample and point-of-care testing
|
0, 6, 12, 24 weeks
|
Hemoglobin a1c
Time Frame: 0, 6, 12, 24 weeks
|
Glycosylated hemoglobin (%) measured via capillary blood sample and point-of-care testing
|
0, 6, 12, 24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical activity and sedentary behavior
Time Frame: 0, 6, 12, 24 weeks
|
Objectively monitored light, moderate, and vigorous physical activity minutes per week
|
0, 6, 12, 24 weeks
|
Sedentary behavior bouts (30 min, 60 min, >60 min)
Time Frame: 0, 6, 12, 24 weeks
|
Objectively monitored number of bouts of sedentary behavior occurring in bouts of 30 minutes or less, 30-60 minutes, and greater than 60 minutes
|
0, 6, 12, 24 weeks
|
Cardiorespiratory fitness
Time Frame: 0, 12 weeks
|
VO2max (mL/kg/min) measured via expired air analysis
|
0, 12 weeks
|
Muscular fitness
Time Frame: 0, 12 weeks
|
Maximal isometric handgrip strength (kg) using an electronic handgrip dynamometer
|
0, 12 weeks
|
Handgrip strength asymmetry
Time Frame: 0, 12 weeks
|
Maximal isometric handgrip strength measured using an electronic handgrip dynamometer on both hands
|
0, 12 weeks
|
Lower-body dynamic balance
Time Frame: 0, 12 weeks
|
Lower-quarter y-balance test distance (cm) on each leg, in the anterior, posteromedial, and posterolateral directions.
|
0, 12 weeks
|
Health-related quality of life using CDC Health-Related Quality of Life Scale
Time Frame: 0, 6, 12, 24 weeks
|
Core healthy days module, activity limitations module.
Core healthy days module measures the number of days over the past 30 days where injury, mental health, was not good and kept individuals from performing usual activities.
Activity limitations asks if individuals are limited by any health problems, how many days they are limited by health problems, and if needs are impaired.
Healthy days symptom module asks if pain, depression, anxiety and sleep were an issue on any number of days over the past 30 days.
Additionally, how many days individuals felt healthy and full of energy over the past 30 days.
|
0, 6, 12, 24 weeks
|
Exercise self-efficacy measured via Self-efficacy for exercise scale
Time Frame: 0, 6, 12, 24 weeks
|
Self-efficacy for exercise scale is 9 items representing various scenarios that are measured on a scale of 1 (not confident) to 10 (very confident) a participant feels to exercise in that scenario.
Higher scores represent higher self-efficacy for exercise participation.
|
0, 6, 12, 24 weeks
|
Perceptions of exercise measured via Views and Attitudes Toward Exercise Scale
Time Frame: 0, 6, 12, 24 weeks
|
Views and attitudes towards exercise scale is 15 items measured on a 7-point Likert scale from strongly disagree (lowest) to strongly agree (highest).
Sum up all responses, higher scores are better perceptions of exercise.
|
0, 6, 12, 24 weeks
|
Perceived stress
Time Frame: 0, 6, 12, 24 weeks
|
Perceived stress scale items are scored from adding up each alternative over 10 items: 0=never, 1=almost never, 2=sometimes, 3=fairly often, 4=very often.
0-13=low stress, 14-26=moderate stress, 27-40=high perceived stress.
|
0, 6, 12, 24 weeks
|
Blood pressure
Time Frame: 0, 6, 12, 24 weeks
|
Systolic and diastolic blood pressure (mmHg) measured via automated blood pressure cuff.
|
0, 6, 12, 24 weeks
|
Body composition
Time Frame: 0, 12, 24 weeks
|
Fat free mass, fat mass in kg using Dual-energy x-ray absorptiometry
|
0, 12, 24 weeks
|
Bone density
Time Frame: 0, 12, 24 weeks
|
Total bone density (g/cm3) using Dual-energy x-ray absorptiometry
|
0, 12, 24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Megan C Nelson, PhD, Northern Michigan University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
April 10, 2024
Primary Completion (Estimated)
December 31, 2024
Study Completion (Estimated)
December 31, 2024
Study Registration Dates
First Submitted
March 18, 2024
First Submitted That Met QC Criteria
April 15, 2024
First Posted (Actual)
April 16, 2024
Study Record Updates
Last Update Posted (Actual)
April 16, 2024
Last Update Submitted That Met QC Criteria
April 15, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- HS-24_51
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
This is a small pilot study; individual participant data will not be shared to protect participants information so that it remains confidential.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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