Climbing Lifestyle Intervention for Modifying Physical Activity Behaviors: Pilot Study (CLIMB)

July 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Michigan
      • Marquette, Michigan, United States, 49855
        • Recruiting
        • Northern Michigan University
        • Contact:
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Indoor Rock Climbing Exercise 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Northern Michigan University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 16, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 18, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 16, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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