Lifestyle FactorsCLIMBNCT06368128
Climbing Lifestyle Intervention for Modifying Physical Activity Behaviors: Pilot Study
A study testing Indoor Rock Climbing Exercise Training Program in people with Lifestyle Factors and Physical Inactivity, run by Northern Michigan University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Lifestyle Factors, Physical Inactivity, Quality of Life
- What is being tested?
- Indoor Rock Climbing Exercise Training Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Northern Michigan University
Marquette, Michigan, 49855
Lisa Eckert, PhD, 906-227-1291, leckert@nmu.edu
Megan C Nelson, PhD
About this study
Official title: 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).
Read the 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).
- Conditions
- Lifestyle Factors, Physical Inactivity, Quality of Life
- Being tested
- Indoor Rock Climbing Exercise Training Program
- Keywords
- Rock Climbing, Cardiovascular Disease Risk Factors, Physical Inactivity, Quality of Life
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indoor Rock Climbing Exercise Training ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants in the control arm will be asked to maintain their current lifestyle behaviors. |
| Intervention | Experimental | Participants in the intervention arm will be asked to partake in a 12-week progressive, supervised, indoor rock climbing training program. Receives: Behavioral: Indoor Rock Climbing Exercise Training Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting lipids
HDL-c; LDL-c; total cholesterol, triglycerides measured via capillary blood sample and point-of-care testing
Measured: 0, 6, 12, 24 weeks
Fasting glucose
glucose (mg/dL) measured via capillary blood sample and point-of-care testing
Measured: 0, 6, 12, 24 weeks
Hemoglobin a1c
Glycosylated hemoglobin (%) measured via capillary blood sample and point-of-care testing
Measured: 0, 6, 12, 24 weeks
Secondary outcomes (13)
Physical activity and sedentary behavior
Objectively monitored light, moderate, and vigorous physical activity minutes per week
Measured: 0, 6, 12, 24 weeks
Sedentary behavior bouts (30 min, 60 min, >60 min)
Objectively monitored number of bouts of sedentary behavior occurring in bouts of 30 minutes or less, 30-60 minutes, and greater than 60 minutes
Measured: 0, 6, 12, 24 weeks
Cardiorespiratory fitness
VO2max (mL/kg/min) measured via expired air analysis
Measured: 0, 12 weeks
Muscular fitness
Maximal isometric handgrip strength (kg) using an electronic handgrip dynamometer
Measured: 0, 12 weeks
Handgrip strength asymmetry
Maximal isometric handgrip strength measured using an electronic handgrip dynamometer on both hands
Measured: 0, 12 weeks
Lower-body dynamic balance
Lower-quarter y-balance test distance (cm) on each leg, in the anterior, posteromedial, and posterolateral directions.
Measured: 0, 12 weeks
Health-related quality of life using CDC Health-Related Quality of Life Scale
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.
Measured: 0, 6, 12, 24 weeks
Exercise self-efficacy measured via Self-efficacy for exercise scale
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.
Measured: 0, 6, 12, 24 weeks
Perceptions of exercise measured via Views and Attitudes Toward Exercise Scale
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.
Measured: 0, 6, 12, 24 weeks
Perceived stress
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.
Measured: 0, 6, 12, 24 weeks
Blood pressure
Systolic and diastolic blood pressure (mmHg) measured via automated blood pressure cuff.
Measured: 0, 6, 12, 24 weeks
Body composition
Fat free mass, fat mass in kg using Dual-energy x-ray absorptiometry
Measured: 0, 12, 24 weeks
Bone density
Total bone density (g/cm3) using Dual-energy x-ray absorptiometry
Measured: 0, 12, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start16 Apr 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lifestyle FactorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial with participants allocated to either a control or intervention group; comparison between groups and within groups
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northern Michigan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Megan C. Nelson, Northern Michigan University
- Investigators
- Megan C Nelson, PhD, Principal investigator, Northern Michigan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06368128
- Sponsor's protocol ID
- HS-24_51
- Acronym
- CLIMB
- Status last verified
- Jul 2024
- First submitted
- 18 Mar 2024
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a small pilot study; individual participant data will not be shared to protect participants information so that it remains confidential.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Climbing Lifestyle Intervention for Modifying Physical Activity Behaviors (CLIMB): Pilot Study
- ClinicalTrials.gov ID
- NCT06368128
- Acronym / sponsor ID
- CLIMB / HS-24_51
- Conditions
- Lifestyle Factors, Physical Inactivity, Quality of Life
- Keywords
- Rock Climbing, Cardiovascular Disease Risk Factors, Physical Inactivity, Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Northern Michigan UniversityUniversity, hospital or other
- Study start
- 16 Apr 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial with participants allocated to either a control or intervention group; comparison between groups and within groups
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants in the control arm will be asked to maintain their current lifestyle behaviors. |
| Intervention | Experimental | Behavioral: Indoor Rock Climbing Exercise Training ProgramParticipants in the intervention arm will be asked to partake in a 12-week progressive, supervised, indoor rock climbing training program. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indoor Rock Climbing Exercise Training ProgramTraining 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. | Behavioural | Intervention |
Primary outcome
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
Fasting glucose
Time frame: 0, 6, 12, 24 weeks
glucose (mg/dL) measured via capillary blood sample and point-of-care testing
Hemoglobin a1c
Time frame: 0, 6, 12, 24 weeks
Glycosylated hemoglobin (%) measured via capillary blood sample and point-of-care testing
13 secondary outcomes
Physical activity and sedentary behavior
Time frame: 0, 6, 12, 24 weeks
Sedentary behavior bouts (30 min, 60 min, >60 min)
Time frame: 0, 6, 12, 24 weeks
Cardiorespiratory fitness
Time frame: 0, 12 weeks
Muscular fitness
Time frame: 0, 12 weeks
Handgrip strength asymmetry
Time frame: 0, 12 weeks
Lower-body dynamic balance
Time frame: 0, 12 weeks
Health-related quality of life using CDC Health-Related Quality of Life Scale
Time frame: 0, 6, 12, 24 weeks
Exercise self-efficacy measured via Self-efficacy for exercise scale
Time frame: 0, 6, 12, 24 weeks
Perceptions of exercise measured via Views and Attitudes Toward Exercise Scale
Time frame: 0, 6, 12, 24 weeks
Perceived stress
Time frame: 0, 6, 12, 24 weeks
Blood pressure
Time frame: 0, 6, 12, 24 weeks
Body composition
Time frame: 0, 12, 24 weeks
Bone density
Time frame: 0, 12, 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Individual participant dataSharing planned: No. This is a small pilot study; individual participant data will not be shared to protect participants information so that it remains confidential.
Related trials for Lifestyle Factors
Active, not recruiting
A Personalized Approach to Abdominal Pain in Irritable Bowel Syndrome
Irritable Bowel Syndrome, Inflammatory Bowel Diseases
RecruitingObservational study
TREC@TAMU Cancer Prevention Registry and Repository
Cancer, Genetics
Active, not recruiting
Healthy Communities: A Healthy City Preventive Program on Cardiovascular Health and Well-being (HC)
Heart Disease Risk Factors, Healthy Lifestyle
Not yet recruiting
Evaluation and Implementation of Digital Health Ecosystem in Academic Health Center
Digital Health Intervention, Remote Consultation, Teleconsultation
Recruiting
Preventative Screening and Health Coaching in a Food Insecure Population
Cardiovascular Disease Prevention, Cardiometabolic Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Megan C Nelson, PhD principal investigator
Northern Michigan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indoor Rock Climbing Exercise Training Program in people with Lifestyle Factors and Physical Inactivity, run by Northern Michigan University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lisa Eckert, PhD (906-227-1291, leckert@nmu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting lipids (time frame: 0, 6, 12, 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2024; AzTrials last refreshed its copy on 30 Oct 2026.